CD3 stimulants(T cell surface glycoprotein CD3 stimulants), GPRC5D inhibitors(G-protein coupled receptor family C group 5member D inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [1]

Active Indication

Refractory Multiple MyelomaRelapse multiple myelomaMultiple Myeloma+ [4]

Inactive Indication-

Originator Organization

Janssen Pharmaceuticals, Inc.

Active Organization

Johnson & Johnson (China) Investment Ltd.

Janssen Pharmaceutica NVJanssen Pharmaceutical KK

+ [8]

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (09 Aug 2023),

Multiple Myeloma

RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (South Korea), Conditional marketing approval (European Union), Priority Review (China)

Structure/Sequence

Sequence Code 10086313H

Source: *****

Sequence Code 10086327L

Source: *****

Sequence Code 453116282H

Source: *****

Sequence Code 525754800L

Source: *****

Clinical Trials associated with Talquetamab

NCT07032714

/ Not yet recruitingPhase 1IIT

MAGENTA: Phase I Study of Mezigdomide and Talquetamab in Relapsed and Refractory Multiple Myeloma

This is a phase 1 study to find the recommended dose and schedule of mezigdomide and talquetamab in relapsed and refractory multiple myeloma (RRMM), and to test the effects of the drugs on cancer. Cohort A will receive talquetamab + dexamethasone, then mezigdomide + talquetamab,+ dexamethasone. After Cohort A, Cohort B will evaluate mezigdomide + dexamethasone followed by step-up dosing of talquetamab (mezigdomide + talquetamab,+ dexamethasone).

Start Date16 Dec 2025

Sponsor / Collaborator

The Massachusetts General Hospital

[+2]

NCT06461988

/ Not yet recruitingPhase 2IIT

An Open-Label, Non-Randomized, Phase II Study to Study the Efficacy of Talquetamab (JNJ-64407564) and Lenalidomide as Post Stem Cell Transplant Maintenance in Multiple Myeloma (OPTIMMAL)

Multiple myeloma (MM) is a heterogenous plasma cell malignancy characterized by clonal proliferation of plasma cells and organ damage. Autologous transplantation with high dose chemotherapy is the standard of care in frontline treatment of eligible patients with MM.

Start Date01 Nov 2025

Sponsor / Collaborator

Stanford University

[+1]

NCT07029776

/ Not yet recruitingPhase 2IIT

A Phase 2 Study Exploring the Use of Bispecific Antibodies to Improve Progression Free Survival in Patients With High-Risk Newly Diagnosed Multiple Myeloma (MMulti-Immune HR)

The purpose of this research is to learn whether using teclistamab and talquetamab at different time points will improve survival in participants with high-risk Multiple Myeloma (MM).
The treatment on this study will consist of Induction chemotherapy and stem cell collection, Immunotherapy 1 chemotherapy and Immunotherapy 2 chemotherapy. For participants whose testing show they are Minimal Residual Disease (MRD) positive (still have myeloma cells present in the bone marrow testing), a Melphalan-based stem cell transplant will be performed. For participants whose testing show they are MRD negative, the stem cell transplant will not be performed. All participants will go on to receive Immunotherapy 3 chemotherapy, Immunotherapy 4 chemotherapy, and Maintenance therapy.

Start Date01 Oct 2025

Sponsor / Collaborator

The University of Arkansas

[+1]

100 Clinical Results associated with Talquetamab

100 Translational Medicine associated with Talquetamab

100 Patents (Medical) associated with Talquetamab

Literatures (Medical) associated with Talquetamab

17 Jul 2025·LARYNGOSCOPE

Talquetamab-Induced Dysgeusia Successfully Treated With Photobiomodulation Therapy.

Article

Author: Kayahara, Giseli Mitsuy ; da Silva, Steffani Nascimento ; Miyahara, Glauco Issamu ; Urazaki, Mariana Stuchi ; Espinhosa, Raissa Baisso ; Bernabé, Daniel Galera ; Cortopassi, Gabriel Macedo ; Pereira, Mariana Aparecida Sanches ; Valente, Vitor Bonetti

Multiple myeloma is a malignancy characterized by clonal proliferation of plasma cells in the bone marrow. The treatment of patients with relapsed or refractory multiple myeloma remains a challenge. Talquetamab is a recently approved drug, a first-in-class GPRC5D-targeting T-cell redirecting bispecific antibody, for treatment of patients with triple-class exposed relapsed/refractory multiple myeloma. Patients who underwent drug therapy have experienced oral side effects such as xerostomia and dysgeusia. This report describes the case of a 61-year old man with triple-class exposed refractory multiple myeloma who developed talquetamab-related dysgeusia that was successfully treated with photobiomodulation (PBM). The patient began to complain of loss of taste three days after the administration of talquetamab. PBM was performed every 48 h with 25 J/cm² per treatment field using the Therapy EC device (DMC; model number: #75153; red: 660 nm ±10 nm; infrared: 808 nm ±10 nm; fixed power of 100 mW ±20%; beam area of 0.04 cm², and irradiance of 2.5 W/cm²) during the talquetamab escalation phase. The application of laser was performed in 78 points distributed throughout the oral cavity. After 7 days/third session of PBM, the patient displayed a significant improvement in sensitivity to tastes, mainly salty and bitter. After 7 weeks of follow-up, there was a slight reduction in sensibility to salty and no change in other tastes. The current clinical report demonstrated the potential effectiveness of a PBM protocol developed for the treatment of talquetamab-related dysgeusia. The management of this oral side effect using PBM could prevent treatment interruption and improve the patients' quality of life.

15 Jul 2025·CANCER

Talquetamab improves patient‐reported symptoms and health‐related quality of life in relapsed or refractory multiple myeloma: Results from the phase 1/2 MonumenTAL‐1 study

Article

Author: Renaud, Thomas ; Kato, Kelly ; Bathija, Sacheeta ; Campagna, Michela ; Katz, Eva G. ; Oriol, Albert ; Qin, Xiang ; Touzeau, Cyrille ; Gries, Katharine S. ; Stevens, Don ; Schinke, Carolina ; Hilder, Brandi W. ; Heuck, Christoph ; Mateos, María‐Victoria ; Tomlinson, Chalmer ; Tolbert, Jaszianne ; Chari, Ajai ; Masterson, Tara ; Rodríguez‐Otero, Paula ; Moreau, Philippe ; San‐Miguel, Jesús ; Rasche, Leo

Abstract:

Background:

Talquetamab is the first approved G protein–coupled receptor family C group 5 member D–targeting bispecific antibody for the treatment of triple‐class exposed relapsed/refractory multiple myeloma (RRMM) on the basis of results from the phase 1/2 MonumenTAL‐1 study (ClinicalTrials.gov identifiers NCT03399799 and NCT04634552). This study describes patient‐reported outcomes (PROs) among patients who received talquetamab in MonumenTAL‐1.

Methods:

PROs were assessed in phase 2 of MonumenTAL‐1. Patients had RRMM with ≥3 prior lines of therapy (proteasome inhibitors, immunomodulatory drugs, and anti‐CD38 antibodies). Patients included in these analyses received talquetamab 0.8 mg/kg every other week. PRO assessments included European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ‐C30), EuroQol 5‐Dimension 5‐Level Visual Analogue Scale (EQ‐5D‐5L VAS), and Patient Global Impression of Severity (PGIS).

Results:

As of January 29, 2024, PRO data were available for 118 patients who received ≥1 dose of talquetamab. Compliance for completion was >95% of patients at baseline and >80% at most posttreatment visits. After an initial worsening in most PROs from baseline through cycle 1, patients reported improvements with continued treatment. At cycle 21, least‐squares mean change from baseline showed improvements in global health status (4.9 points) and emotional functioning (12.5 points), along with reductions in pain (11.4 points) and fatigue (4.0 points). The proportion of patients with clinically meaningful improvements or no change from baseline increased throughout treatment. EQ‐5D‐5L VAS and PGIS scores demonstrated improvement in health‐related quality of life.

Conclusions:

These PRO results complement the efficacy and safety profile of talquetamab, which highlights talquetamab as a viable treatment option for patients with triple‐class exposed RRMM.

08 Jul 2025·Blood Advances

Restarting teclistamab and talquetamab after prolonged dose delay may not require re–step-up dosing

Article

Author: Patel, Dhwani ; Mailankody, Sham ; Hassoun, Hani ; Hamadeh, Issam ; Landau, Heather J. ; Shah, Gunjan L. ; Giralt, Sergio A. ; Hultcrantz, Malin ; Miller, Kevin ; Lesokhin, Alexander ; Wang, Alice ; Hashmi, Hamza ; Nemirovsky, David ; Firestone, Ross ; Korde, Neha ; Tan, Carlyn Rose ; Rajeeve, Sridevi ; Shekarkhand, Tala ; Shah, Urvi A. ; Maclachlan, Kylee ; Usmani, Saad Z. ; Derkach, Andriy ; Jurgens, Eric ; Scordo, Michael

120

News (Medical) associated with Talquetamab

16 Jul 2025

·www.biopharmadive.com

J&J absorbs Stelara, tariff hits to deliver beat-and-raise quarter

Johnson & Johnson on Wednesday reported quarterly prescription drug sales that for the first time surpassed $15 billion, highlighting the strength of the pharmaceutical companys portfolio during a year in which its formerly top-selling drug lost market exclusivity.Second quarter sales for J&Js pharmaceuticals business reached $15.2 billion between April and June, nearly 4% higher than the same period last year on an operational basis. Overall second quarter sales were up 4.6% on the same basis to total $23.7 billion, beating Wall Street forecasts.J&J now expects higher operational growth for 2025, increasing the midpoint of its guidance range for both adjusted sales and earnings per share.The company also halved its estimates for how much U.S. tariffs would weigh on its business this year. It now anticipates a roughly $200 million hit, exclusively within its medical device unit. President Donald Trump has said further levies on pharmaceuticals are coming soon, but indicated the duties would be phased in, potentially giving drugmakers time to adjust their operations and stockpile inventory.J&J shares jumped by more than 6% Wednesday morning following its earnings release.No other healthcare company has grown through the loss of exclusivity of a multibillion-dollar product in the first year, in our case Stelara, J&J CEO Joaquin Duato said on a conference call with analysts, referring to the companys 16-year-old psoriasis and inflammatory bowel disease medicine.Stelara sales during the quarter fell by 43% year over year, to $1.7 billion.J&J has a newer drug, Tremfya, that it has positioned as a successor to Stelara in many of the same diseases and hopes will eventually grow into a $10 billion-a-year product. Sales in the second quarter rose 30% year over year to $1.2 billion as more doctors prescribed it for Crohns disease and ulcerative colitis.But its J&Js oncology business thats providing the most significant counterweight to Stelaras loss of exclusivity. Overall cancer drug sales were $6.3 billion between April and June, more than $1 billion higher than in the same period last year.Over half of that total came from J&Js multiple myeloma medicine Darzalex, which is one of several drugs the company sells for the blood cancer. Duato claimed about 80% of all multiple myeloma patients receive a J&J therapy as some point in their treatment.By the end of the decade, J&J predicts its oncology business will bring in $50 billion in annual sales, notably higher than what analysts on Wall Street currently estimate.Jennifer Taubert, head of the companys pharmaceuticals business, pointed to Darzalex and its multiple myeloma cell therapy Carvykti as key contributors to that goal. Two other J&J medicines, Tecvayli and Talvey, are also approved for the blood cancer, but are early in their respective launches.Taubert also highlighted a drug-device combination called TAR-200 that J&J is targeting for use in non-muscle invasive bladder cancer. That is probably the asset that has the biggest disconnect between our internal forecasts and what the Street expects, she said. If you take a look at 2028 consensus, we actually see our numbers at least three times higher.J&J previously detailed several other drugs for which analysts forecasts diverge from its own. One other is a combination of the medicines Rybrevant and Lazcluze, which are approved for a certain type of metastatic lung cancer. The company aims to win U.S. clearance for a subcutaneous version of Rybrevant, but had its application rejected by the Food and Drug Administration in December.On Wednesdays call, Taubert said the agencys complete response letter related to a manufacturing question or two and J&J has since responded. '

Drug ApprovalCell Therapy

16 Jul 2025

·www.investor.jnj.com

Johnson & Johnson Reports Q2 2025 Results; Raises 2025 Outlook

2025 Second-Quarter reported sales growth of 5.8% to $23.7 Billion with operational growth of 4.6%* and adjusted operational growth of 3.0%* 2025 Second-Quarter reflects earnings per share (EPS) of $2.29 and adjusted EPS of $2.77 Significant new product pipeline progress including approval of IMAAVY for generalized myasthenia gravis, priority review for TAR-200, data for CARVYKTI overall survival and progression-free benefits in multiple myeloma, and continuation of the clinical trial for a general surgery robotic system, OTTAVA Strong operational performance and favorable foreign exchange results in Company increasing full year estimated reported sales5 guidance at the midpoint by $2 billion dollars to 5.4% and full year EPS guidance by $0.25 to $10.85. Adjusted operational EPS increased to $10.68 at the midpoint. NEW BRUNSWICK, N.J.--(BUSINESS WIRE)-- Johnson & Johnson (NYSE: JNJ) today announced results for second-quarter 2025. “Today’s strong results reflect the depth and strength of Johnson & Johnson’s uniquely diversified business operating across both MedTech and Innovative Medicine,” said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. “Our portfolio and pipeline position us for elevated growth in the second half of the year, with game-changing approvals and submissions anticipated in areas like lung and bladder cancer, major depressive disorder, psoriasis, surgery and cardiovascular, which will extend and improve lives in transformative ways.” Overall financial results Q2 ($ in Millions, except EPS) 2025 2024 % Change Reported Sales $23,743 $22,447 5.8% Net Earnings $5,537 $4,686 18.2% EPS (diluted) $2.29 $1.93 18.7% Q2 Non-GAAP* ($ in Millions, except EPS) 2025 2024 % Change Operational Sales1,2 4.6% Adjusted Operational Sales1,3 3.0% Adjusted Net Earnings1,4 $6,699 $6,840 -2.1% Adjusted EPS (diluted)1,4 $2.77 $2.82 -1.8% Free Cash Flow6,7 ~$6,200 $7,507 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency 4 Excludes intangible amortization expense and special items 5 Excludes COVID-19 Vaccine 6 Non-GAAP measure; defined as cash flow from operating activities, less additions to property, plant and equipment. Cash flow from operations, the most directly comparable GAAP financial measure, will be included in subsequent SEC filings. 7 Second-quarter YTD 2025 is estimated as of July 16, 2025 Regional sales results Q2 % Change ($ in Millions) 2025 2024 Reported Operational1,2 Currency Adjusted Operational1,3 U.S. $13,544 $12,569 7.8% 7.8 - 5.0 International 10,199 9,878 3.2 0.6 2.6 0.4 Worldwide $23,743 $22,447 5.8% 4.6 1.2 3.0 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency Segment sales results Q2 % Change ($ in Millions) 2025 2024 Reported Operational1,2 Currency Adjusted Operational1,3 Innovative Medicine $15,202 $14,490 4.9% 3.8 1.1 2.4 MedTech 8,541 7,957 7.3 6.1 1.2 4.1 Worldwide $23,743 $22,447 5.8% 4.6 1.2 3.0 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency Second-Quarter 2025 segment commentary: Operational sales* reflected below excludes the impact of translational currency. Innovative Medicine Innovative Medicine worldwide operational sales grew 3.8%*, with net acquisitions and divestitures positively impacting growth by 1.4%. Growth was primarily driven by DARZALEX, CARVYKTI, ERLEADA and RYBREVANT/LAZCLUZE in Oncology, TREMFYA and SIMPONI/SIMPONI ARIA in Immunology, and SPRAVATO in Neuroscience. Growth was partially offset by an approximate (1,170) basis points impact from STELARA in Immunology, and an approximate (130) basis points impact from COVID-19 in Infectious Diseases. MedTech MedTech worldwide operational sales grew 6.1%*, with net acquisitions and divestitures positively impacting growth by 2.0%. Growth was primarily driven by electrophysiology products and Abiomed in Cardiovascular, as well as wound closure products in General Surgery. Full-year 2025 guidance: Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses, and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson's results computed in accordance with GAAP. ($ in Billions, except EPS) July 2025 April 2025 Adjusted Operational Sales1,2,5 Change vs. Prior Year / Mid-point 3.2% – 3.7% / 3.5% 2.0% – 3.0% / 2.5% Operational Sales2,5 / Mid-point Change vs. Prior Year / Mid-point $92.7B – $93.1B / $92.9B 4.5% – 5.0% / 4.8% $91.6B – $92.4B / $92.0B 3.3% – 4.3% / 3.8% Estimated Reported Sales3,5/ Mid-point Change vs. Prior Year / Mid-point $93.2B – $93.6B / $93.4B 5.1% – 5.6% / 5.4% $91.0B – $91.8B / $91.4B 2.6% – 3.6% / 3.1% 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% $10.50 – $10.70 / $10.60 5.2% – 7.2% / 6.2% 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% $10.50 – $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: July 2025 = $1.13 and April 2025 = $1.10 (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 Supplemental new drug application submitted to U.S. FDA for CAPLYTA® (lumateperone) with data demonstrating significant schizophrenia relapse prevention compared to placebo1 Press Release DARZALEX® (daratumumab) receives the first positive CHMP opinion for patients with high-risk smouldering multiple myeloma Press Release IMBRUVICA® (ibrutinib) receives positive CHMP opinion for the treatment of patients with previously untreated mantle cell lymphoma (MCL) who would be eligible for autologous stem cell transplant Press Release U.S. FDA Oncologic Drugs Advisory Committee votes in favor of the benefit-risk profile of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for high-risk smoldering multiple myeloma Press Release Johnson & Johnson receives FDA approval for IMAAVY™ (nipocalimab-aahu), a new FcRn blocker offering long-lasting disease control in the broadest population of people living with generalized myasthenia gravis (gMG) Press Release Johnson & Johnson MedTech Announces Completion of First Cases with OTTAVA™ Robotic Surgical System Press Release Data Releases IMAAVY™ (nipocalimab-aahu) showed greater sustained disease control versus approved FcRn blockers for generalized myasthenia gravis (gMG) at multiple timepoints over 24 weeks in newly published indirect treatment comparison (ITC) Press Release Investigational combination of first-in-class bispecifics TALVEY® and TECVAYLI® shows deep and durable responses in heavily pretreated multiple myeloma patients with extramedullary disease Press Release Johnson & Johnson's dual-targeting CAR T-cell therapy shows encouraging first results in large B-cell lymphoma Press Release New results for Johnson & Johnson's bleximenib demonstrate promising antileukemic activity in combination with venetoclax and azacitidine for acute myeloid leukemia Press Release Significant efficacy benefit of IMBRUVICA® (ibrutinib) plus venetoclax versus acalabrutinib plus venetoclax in frontline treatment of patients with chronic lymphocytic leukaemia suggested by indirect treatment comparison Press Release New data show TREMFYA® (guselkumab) is the only IL-23 inhibitor proven to significantly inhibit progression of joint structural damage in active psoriatic arthritis Press Release DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based regimen shows 95 percent progression-free survival at four years in transplant-eligible, newly diagnosed patients with multiple myeloma who achieved sustained MRD negativity Press Release Early results from Johnson & Johnson's trispecific antibody show promising response in heavily pretreated multiple myeloma patients Press Release Single infusion of CARVYKTI® (ciltacabtagene autoleucel) delivered lasting treatment-free remissions for at least five years in patients with relapsed or refractory multiple myeloma Press Release Johnson & Johnson leads with first PARP inhibitor combo to improve efficacy in patients with HRR-altered mCSPC Press Release Johnson & Johnson unveils first-in-human results for pasritamig, showing early anti-tumor activity in prostate cancer Press Release Shockwave Medical Study Confirms Benefit of IVL-First Strategy in Real-World Female Patients with Complex Calcified Lesions in Late-Breaking Data Presentation at EuroPCR 2025 Press Release Icotrokinra results show significant skin clearance in patients with difficult-to-treat scalp and genital psoriasis Press Release TREMFYA® (guselkumab) delivers sustained clinical and endoscopic remission in ulcerative colitis through two years Press Release TREMFYA® (guselkumab) positioned to become the first and only IL-23 inhibitor to offer subcutaneous induction in ulcerative colitis as demonstrated in new data through 24 weeks Press Release Johnson & Johnson's TAR-200 monotherapy achieves high disease-free survival of more than 80 percent in BCG-unresponsive, high-risk papillary NMIBC Press Release Johnson & Johnson's TAR-200 monotherapy demonstrates highest complete response rate with sustained clinical benefits in patients with certain types of bladder cancer Press Release Johnson & Johnson MedTech Presents 3-Month Data from Omny-IRE Clinical Trial at 2025 Heart Rhythm Society Annual Meeting Press Release Product Launch Johnson & Johnson Launches First and Only Daily Disposable Multifocal Toric Contact Lens - ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM Press Release Johnson & Johnson Launches VOLT™ Wrist and Proximal Humerus Plating Systems in the U.S. Press Release Johnson & Johnson Launches New TECNIS Odyssey Next-Generation Intraocular Lens in Europe, the Middle East, and Canada Offering Cataract Patients Precise Vision at Every Distance in Any Lighting Press Release Johnson & Johnson Launches KINCISE™ 2 System, the Only Automated Surgical Impactor Approved for Knee and Hip Revision Procedures Press Release Johnson & Johnson MedTech Launches SOUNDSTAR CRYSTAL™ in the US, Redefining Image Clarity in 2D Intracardiac Imaging Press Release Other Johnson & Johnson Elects Daniel Pinto, President, JPMorganChase 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. Percent Change Percent Change 2025 2024 Total Operations Currency 2025 2024 Total Operations Currency $ 9,161 8,510 7.6 % 7.6 - $ 17,253 16,122 7.0 % 7.0 - 6,041 5,980 1.0 (1.6 ) 2.6 11,822 11,930 (0.9 ) (0.1 ) (0.8 ) 15,202 14,490 4.9 3.8 1.1 29,075 28,052 3.6 4.0 (0.4 ) 4,383 4,059 8.0 8.0 - 8,596 8,067 6.6 6.6 - 4,158 3,898 6.7 4.1 2.6 7,965 7,711 3.3 3.6 (0.3 ) 8,541 7,957 7.3 6.1 1.2 16,561 15,778 5.0 5.1 (0.1 ) 13,544 12,569 7.8 7.8 - 25,849 24,189 6.9 6.9 - 10,199 9,878 3.2 0.6 2.6 19,787 19,641 0.7 1.4 (0.7 ) $ 23,743 22,447 5.8 % 4.6 1.2 $ 45,636 43,830 4.1 % 4.4 (0.3 ) Percent Change Percent Change 2025 2024 Total Operations Currency 2025 2024 Total Operations Currency $ 13,544 12,569 7.8 % 7.8 - $ 25,849 24,189 6.9 % 6.9 - 5,387 5,214 3.3 (1.9 ) 5.2 10,497 10,377 1.1 0.2 0.9 1,206 1,212 (0.5 ) 6.2 (6.7 ) 2,373 2,406 (1.3 ) 7.7 (9.0 ) 3,606 3,452 4.4 2.4 2.0 6,917 6,858 0.9 0.9 0.0 10,199 9,878 3.2 0.6 2.6 19,787 19,641 0.7 1.4 (0.7 ) $ 23,743 22,447 5.8 % 4.6 1.2 $ 45,636 43,830 4.1 % 4.4 (0.3 ) 2025 2024 Percent Percent Percent Increase Amount to Sales Amount to Sales (Decrease) $ 23,743 100.0 $ 22,447 100.0 5.8 7,628 32.1 6,869 30.6 11.0 16,115 67.9 15,578 69.4 3.4 5,889 24.8 5,681 25.3 3.7 3,516 14.8 3,440 15.3 2.2 - - 194 0.9 48 0.2 (125 ) (0.6 ) 107 0.5 653 2.9 64 0.3 (13 ) 0.0 6,491 27.3 5,748 25.6 12.9 954 4.0 1,062 4.7 (10.2 ) $ 5,537 23.3 $ 4,686 20.9 18.2 $ 2.29 $ 1.93 18.7 2,419.1 2,422.0 14.7 % 18.5 % $ 8,188 34.5 $ 8,404 37.4 (2.6 ) $ 6,699 28.2 $ 6,840 30.5 (2.1 ) $ 2.77 $ 2.82 (1.8 ) 18.2 % 18.6 % 2025 2024 Percent Percent Percent Increase Amount to Sales Amount to Sales (Decrease) $ 45,636 100.0 $ 43,830 100.0 4.1 14,985 32.8 13,380 30.5 12.0 30,651 67.2 30,450 69.5 0.7 11,001 24.1 10,938 25.0 0.6 6,741 14.8 6,982 16.0 (3.5 ) - - 194 0.4 (80 ) (0.2 ) (334 ) (0.8 ) (7,214 ) (15.8 ) 3,057 7.0 81 0.2 151 0.3 20,122 44.1 9,462 21.6 112.7 3,586 7.9 1,521 3.5 135.8 $ 16,536 36.2 $ 7,941 18.1 108.2 $ 6.82 $ 3.27 108.6 2,423.3 2,428.5 17.8 % 16.1 % $ 16,199 35.5 $ 16,281 37.1 (0.5 ) $ 13,405 29.4 $ 13,420 30.6 (0.1 ) $ 5.53 $ 5.53 0.0 17.2 % 17.6 % 2025 2024 2025 2024 $5,537 $4,686 $16,536 $7,941 57 352 (6,909) 3,078 1,267 1,106 2,387 2,184 - 64 - 73 79 (11) 134 160 - 68 - 119 246 452 378 600 21 431 60 411 - 194 - 194 27 - 27 - (321) (437) 994 (1,293) (214) (65) (202) (47) $6,699 $6,840 $13,405 $13,420 2,419.1 2,422.0 2,423.3 2,428.5 $2.77 $2.82 $5.53 $5.53 $2.71 $5.52 1 2 4.9% 7.3% 5.8% 7.6% 8.0% 7.8% 1.0% 6.7% 3.2% 1.1 1.2 1.2 - - - 2.6 2.6 2.6 3.8% 6.1% 4.6% 7.6% 8.0% 7.8% (1.6)% 4.1% 0.6% (2.2) (0.8) (3.5) (1.1) (0.9) (0.3) (1.4) (0.9) (2.4) (1.7) 0.0 0.0 0.0 0.2 0.1 0.0 0.2 0.0 0.0 0.2 0.1 2.4% 4.1% 3.0% 5.2% 4.7% 5.0% (1.6)% 3.4% 0.4% Innovative Medicine MedTech Total 3.6% 5.0% 4.1% 7.0% 6.6% 6.9% (0.9)% 3.3% 0.7% (0.4) (0.1) (0.3) - - - (0.8) (0.3) (0.7) 4.0% 5.1% 4.4% 7.0% 6.6% 6.9% (0.1)% 3.6% 1.4% (2.7) (1.0) (4.3) (1.5) (1.1) (0.5) (0.8) (0.5) (1.3) (0.9) 0.0 0.0 0.1 0.3 0.2 0.0 0.5 0.2 0.2 0.2 0.2 3.3% 2.7% 3.1% 5.7% 2.8% 4.7% 0.1% 2.7% 1.1% REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) SECOND QUARTER SIX MONTHS % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 3,385 2,636 28.4 % 28.4 % - $ 6,398 5,019 27.5 % 27.5 % - 2,928 2,455 19.3 % 15.7 % 3.6 % 5,592 4,885 14.5 % 15.1 % -0.6 % 6,312 5,090 24.0 % 22.3 % 1.7 % 11,990 9,904 21.1 % 21.3 % -0.2 % 358 167 * * - 676 307 * * - 81 20 * * * 132 36 * * * 439 186 * * * 808 343 * * * 2,017 1,641 23.0 % 23.0 % - 3,846 3,105 23.9 % 23.9 % - 1,521 1,237 23.0 % 19.6 % 3.4 % 2,930 2,465 18.9 % 19.7 % -0.8 % 3,539 2,878 23.0 % 21.5 % 1.5 % 6,776 5,570 21.7 % 22.0 % -0.3 % 378 318 18.6 % 18.6 % - 670 603 11.0 % 11.0 % - 530 418 27.0 % 22.8 % 4.2 % 1,009 822 22.9 % 23.0 % -0.1 % 908 736 23.4 % 21.0 % 2.4 % 1,679 1,425 17.8 % 17.9 % -0.1 % 239 246 -2.7 % -2.7 % - 474 511 -7.3 % -7.3 % - 496 525 -5.4 % -8.4 % 3.0 % 970 1,043 -6.9 % -6.3 % -0.6 % 735 770 -4.5 % -6.6 % 2.1 % 1,444 1,554 -7.0 % -6.6 % -0.4 % 139 52 * * - 252 88 * * - 41 17 * * * 69 28 * * * 179 69 * * * 320 116 * * * 82 59 38.0 % 38.0 % - 150 109 36.7 % 36.7 % - 24 9 * * * 42 17 * * * 106 69 55.0 % 54.3 % 0.7 % 192 127 52.0 % 52.4 % -0.4 % 114 104 8.2 % 8.2 % - 219 205 6.6 % 6.6 % - 52 30 74.8 % 72.0 % 2.8 % 98 63 56.0 % 58.4 % -2.4 % 166 135 23.1 % 22.4 % 0.7 % 317 268 18.2 % 18.7 % -0.5 % 6 11 -38.9 % -38.9 % - 13 20 -31.9 % -31.9 % - 139 154 -9.8 % -13.3 % 3.5 % 257 326 -21.1 % -21.3 % 0.2 % 145 165 -11.6 % -14.9 % 3.3 % 270 346 -21.7 % -21.9 % 0.2 % 50 37 36.9 % 36.9 % - 97 70 39.8 % 39.8 % - 42 45 -8.7 % -12.3 % 3.6 % 84 86 -2.5 % -1.8 % -0.7 % 93 83 11.7 % 9.7 % 2.0 % 182 156 16.4 % 16.8 % -0.4 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) SECOND QUARTER SIX MONTHS % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 2,505 2,978 -15.9 % -15.9 % - $ 4,701 5,431 -13.4 % -13.4 % - 1,489 1,744 -14.6 % -16.2 % 1.6 % 2,999 3,538 -15.2 % -13.8 % -1.4 % 3,993 4,722 -15.4 % -16.0 % 0.6 % 7,700 8,969 -14.1 % -13.6 % -0.5 % 283 231 22.5 % 22.5 % - 597 497 20.1 % 20.1 % - 34 35 -2.6 % -2.6 % - 44 62 -28.7 % -28.7 % - 138 127 8.6 % 8.8 % -0.2 % 281 268 4.8 % 7.7 % -2.9 % 455 393 15.9 % 15.9 % 0.0 % 922 827 11.5 % 12.4 % -0.9 % 305 267 14.0 % 14.0 % - 597 521 14.4 % 14.4 % - 387 270 43.1 % 40.8 % 2.3 % 753 569 32.2 % 35.0 % -2.8 % 690 537 28.6 % 27.5 % 1.1 % 1,349 1,091 23.7 % 25.1 % -1.4 % 1,078 1,855 -41.9 % -41.9 % - 2,059 3,251 -36.7 % -36.7 % - 575 1,030 -44.2 % -45.6 % 1.4 % 1,219 2,085 -41.5 % -40.6 % -0.9 % 1,653 2,885 -42.7 % -43.2 % 0.5 % 3,278 5,336 -38.6 % -38.2 % -0.4 % 796 589 35.2 % 35.2 % - 1,395 1,098 27.1 % 27.1 % - 391 317 23.2 % 20.5 % 2.7 % 747 616 21.2 % 22.4 % -1.2 % 1,186 906 31.0 % 30.1 % 0.9 % 2,142 1,714 25.0 % 25.4 % -0.4 % 8 2 * * - 9 2 * * - 0 0 - - - 0 0 - - - 8 2 * * - 9 2 * * - 1,377 1,102 24.9 % 24.9 % - 2,345 2,156 8.7 % 8.7 % - 674 679 -0.8 % -2.6 % 1.8 % 1,353 1,428 -5.2 % -4.1 % -1.1 % 2,051 1,782 15.1 % 14.4 % 0.7 % 3,698 3,585 3.2 % 3.6 % -0.4 % 211 - * * - 211 - * * - - - - - - - - - - - 211 - * * - 211 - * * - 24 34 -27.7 % -27.7 % - 62 75 -16.6 % -16.6 % - 139 129 7.5 % 7.0 % 0.5 % 249 265 -6.0 % -4.4 % -1.6 % 164 163 0.2 % -0.2 % 0.4 % 312 340 -8.3 % -7.1 % -1.2 % 732 784 -6.7 % -6.7 % - 1,357 1,549 -12.4 % -12.4 % - 260 269 -3.5 % -5.1 % 1.6 % 537 561 -4.2 % -3.1 % -1.1 % 992 1,054 -5.9 % -6.3 % 0.4 % 1,895 2,110 -10.2 % -9.9 % -0.3 % 366 226 61.1 % 61.1 % - 642 417 53.7 % 53.7 % - 50 44 12.8 % 11.0 % 1.8 % 93 78 18.1 % 20.1 % -2.0 % 414 271 53.3 % 53.0 % 0.3 % 734 496 48.1 % 48.4 % -0.3 % 45 57 -23.5 % -23.5 % - 73 115 -37.0 % -37.0 % - 226 237 -4.7 % -7.6 % 2.9 % 474 524 -9.5 % -8.8 % -0.7 % 270 294 -8.4 % -10.7 % 2.3 % 547 639 -14.4 % -13.9 % -0.5 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) SECOND QUARTER SIX MONTHS % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 799 743 7.6 % 7.6 % - $ 1,543 1,509 2.3 % 2.3 % - 314 296 5.8 % 2.8 % 3.0 % 595 579 2.6 % 3.0 % -0.4 % 1,113 1,039 7.1 % 6.2 % 0.9 % 2,138 2,088 2.4 % 2.5 % -0.1 % 403 376 6.9 % 6.9 % - 766 732 4.6 % 4.6 % - 180 171 5.4 % 2.1 % 3.3 % 339 340 -0.3 % -0.2 % -0.1 % 582 548 6.4 % 5.4 % 1.0 % 1,104 1,072 3.0 % 3.1 % -0.1 % 382 349 9.4 % 9.4 % - 747 741 0.8 % 0.8 % - 94 76 22.4 % 19.8 % 2.6 % 180 152 17.9 % 18.7 % -0.8 % 476 426 11.7 % 11.3 % 0.4 % 927 894 3.7 % 3.8 % -0.1 % 16 17 -12.4 % -12.4 % - 31 35 -12.6 % -12.6 % - 40 49 -18.5 % -21.3 % 2.8 % 77 88 -12.4 % -12.1 % -0.3 % 55 67 -16.9 % -19.0 % 2.1 % 107 123 -12.5 % -12.3 % -0.2 % 320 334 -4.3 % -4.3 % - 635 658 -3.6 % -3.6 % - 484 631 -23.4 % -26.8 % 3.4 % 971 1,128 -13.9 % -14.1 % 0.2 % 803 965 -16.8 % -19.0 % 2.2 % 1,605 1,786 -10.1 % -10.2 % 0.1 % 6 8 -25.4 % -25.4 % - 14 16 -13.6 % -13.6 % - 354 288 23.0 % 16.7 % 6.3 % 704 603 16.7 % 15.6 % 1.1 % 360 297 21.6 % 15.5 % 6.1 % 718 620 15.9 % 14.9 % 1.0 % 312 321 -3.0 % -3.0 % - 617 635 -2.9 % -2.9 % - 85 117 -27.0 % -29.4 % 2.4 % 183 221 -17.2 % -15.8 % -1.4 % 396 438 -9.4 % -10.0 % 0.6 % 799 856 -6.6 % -6.3 % -0.3 % 2 5 -51.8 % -51.8 % - 4 7 -37.4 % -37.4 % - 45 227 -80.5 % -80.6 % 0.1 % 84 304 -72.5 % -72.1 % -0.4 % 47 233 -79.8 % -79.9 % 0.1 % 88 311 -71.7 % -71.3 % -0.4 % 776 717 8.2 % 8.2 % - 1,631 1,348 21.0 % 21.0 % - 154 176 -12.3 % -13.2 % 0.9 % 312 373 -16.2 % -14.3 % -1.9 % 930 892 4.2 % 4.0 % 0.2 % 1,943 1,721 12.9 % 13.3 % -0.4 % 621 587 5.6 % 5.6 % - 1,311 1,105 18.6 % 18.6 % - - - - - - - - - - - 621 587 5.6 % 5.6 % - 1,311 1,105 18.6 % 18.6 % - 155 129 20.0 % 20.0 % - 320 243 31.6 % 31.6 % - 154 176 -12.3 % -13.2 % 0.9 % 312 373 -16.2 % -14.3 % -1.9 % 309 305 1.4 % 0.9 % 0.5 % 632 616 2.7 % 3.9 % -1.2 % 9,161 8,510 7.6 % 7.6 % - 17,253 16,122 7.0 % 7.0 % - 6,041 5,980 1.0 % -1.6 % 2.6 % 11,822 11,930 -0.9 % -0.1 % -0.8 % $ 15,202 14,490 4.9 % 3.8 % 1.1 % $ 29,075 28,052 3.6 % 4.0 % -0.4 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) SECOND QUARTER SIX MONTHS % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 1,364 1,119 21.9 % 21.9 % - $ 2,625 2,144 22.4 % 22.4 % - 948 753 25.9 % 22.9 % 3.0 % 1,790 1,534 16.7 % 16.7 % 0.0 % 2,313 1,873 23.5 % 22.3 % 1.2 % 4,416 3,679 20.0 % 20.0 % 0.0 % 741 705 5.1 % 5.1 % - 1,425 1,397 2.0 % 2.0 % - 728 618 17.8 % 15.2 % 2.6 % 1,366 1,270 7.6 % 7.8 % -0.2 % 1,468 1,323 11.0 % 9.8 % 1.2 % 2,791 2,667 4.7 % 4.7 % 0.0 % 360 309 16.6 % 16.6 % - 699 612 14.2 % 14.2 % - 89 72 25.0 % 18.4 % 6.6 % 170 139 22.4 % 20.9 % 1.5 % 448 379 18.2 % 16.9 % 1.3 % 868 750 15.7 % 15.5 % 0.2 % 233 77 * * - 439 77 * * - 58 0 * * * 110 0 * * * 292 77 * * * 550 77 * * - 31 29 5.4 % 5.4 % - 63 59 6.3 % 6.3 % - 72 64 13.4 % 11.6 % 1.8 % 144 126 14.2 % 14.5 % -0.3 % 104 93 10.8 % 9.7 % 1.1 % 207 185 11.7 % 11.8 % -0.1 % 1,420 1,422 -0.2 % -0.2 % - 2,804 2,870 -2.3 % -2.3 % - 885 890 -0.5 % -4.0 % 3.5 % 1,742 1,782 -2.2 % -2.4 % 0.2 % 2,305 2,312 -0.3 % -1.6 % 1.3 % 4,546 4,652 -2.3 % -2.3 % 0.0 % 271 265 2.1 % 2.1 % - 534 535 -0.2 % -0.2 % - 150 152 -1.0 % -4.3 % 3.3 % 296 304 -2.5 % -2.6 % 0.1 % 421 417 1.0 % -0.2 % 1.2 % 830 839 -1.1 % -1.1 % 0.0 % 226 230 -1.9 % -1.9 % - 457 472 -3.1 % -3.1 % - 164 163 0.0 % -2.9 % 2.9 % 322 323 -0.5 % -0.4 % -0.1 % 389 394 -1.1 % -2.3 % 1.2 % 778 795 -2.0 % -2.0 % 0.0 % 501 498 0.7 % 0.7 % - 1,003 1,002 0.1 % 0.1 % - 267 260 2.2 % -1.5 % 3.7 % 537 521 2.9 % 2.8 % 0.1 % 768 759 1.2 % -0.1 % 1.3 % 1,540 1,524 1.1 % 1.0 % 0.1 % 422 430 -1.7 % -1.7 % - 810 862 -6.0 % -6.0 % - 305 314 -2.7 % -6.4 % 3.7 % 588 634 -7.2 % -7.7 % 0.5 % 727 743 -2.1 % -3.7 % 1.6 % 1,398 1,495 -6.5 % -6.7 % 0.2 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) SECOND QUARTER SIX MONTHS % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 1,043 995 4.8 % 4.8 % - $ 2,045 1,982 3.2 % 3.2 % - 1,512 1,493 1.3 % -0.2 % 1.5 % 2,906 2,922 -0.5 % 0.3 % -0.8 % 2,555 2,488 2.7 % 1.8 % 0.9 % 4,951 4,904 1.0 % 1.5 % -0.5 % 477 466 2.2 % 2.2 % - 934 912 2.4 % 2.4 % - 687 675 1.9 % 0.2 % 1.7 % 1,303 1,316 -1.0 % -0.4 % -0.6 % 1,164 1,141 2.0 % 1.0 % 1.0 % 2,237 2,228 0.4 % 0.8 % -0.4 % 567 528 7.2 % 7.2 % - 1,111 1,070 3.8 % 3.8 % - 825 818 0.9 % -0.6 % 1.5 % 1,603 1,606 -0.1 % 0.8 % -0.9 % 1,391 1,346 3.3 % 2.5 % 0.8 % 2,714 2,676 1.4 % 2.0 % -0.6 % 557 523 6.5 % 6.5 % - 1,123 1,070 4.9 % 4.9 % - 813 763 6.5 % 3.4 % 3.1 % 1,526 1,473 3.6 % 3.7 % -0.1 % 1,369 1,285 6.5 % 4.6 % 1.9 % 2,648 2,543 4.1 % 4.2 % -0.1 % 429 409 4.8 % 4.8 % - 881 847 3.9 % 3.9 % - 536 509 5.4 % 1.4 % 4.0 % 1,003 981 2.3 % 1.9 % 0.4 % 965 918 5.1 % 2.9 % 2.2 % 1,884 1,828 3.1 % 2.8 % 0.3 % 128 113 12.6 % 12.6 % - 242 223 8.5 % 8.5 % - 277 254 8.8 % 7.3 % 1.5 % 523 492 6.2 % 7.2 % -1.0 % 403 367 9.9 % 8.9 % 1.0 % 764 715 6.9 % 7.6 % -0.7 % 4,383 4,059 8.0 % 8.0 % - 8,596 8,067 6.6 % 6.6 % - 4,158 3,898 6.7 % 4.1 % 2.6 % 7,965 7,711 3.3 % 3.6 % -0.3 % $ 8,541 7,957 7.3 % 6.1 % 1.2 % $ 16,561 15,778 5.0 % 5.1 % -0.1 % Second Quarter June 29, 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 Second Quarter June 29, 2025 Non-GAAP $ 3,978 (785 ) (13 ) 3,180 2,789 2,789 2,869 2,869 14 69 (207 ) 8 (13 ) (129 ) 5,552 785 (69 ) - 220 (8 ) - 13 6,493 $ 3,638 (482 ) (15 ) 1 3,142 2,862 2,862 647 43 690 190 (83 ) (64 ) (53 ) (29 ) (14 ) (53 ) 1,204 482 83 79 9 29 - 14 1,900 $ 12 12 238 238 - - 15 (43 ) (17 ) (45 ) (265 ) - 43 - 17 - - - (205 ) $ 7,628 (1,267 ) (15 ) (12 ) 6,334 5,889 5,889 3,516 43 3,559 107 (57 ) (277 ) (21 ) (27 ) (275 ) - - 48 48 64 (64 ) - 6,491 1,267 57 79 246 21 - 27 8,188 954 222 9 13 72 5 214 - 1,489 5,537 1,045 48 66 174 16 (214 ) 27 6,699 $ 3,603 (694 ) (4 ) 2,905 2,665 2,665 2,722 (10 ) 2,712 41 (43 ) (194 ) 63 (1 ) (70 ) (50 ) (254 ) 5,459 694 43 194 (63 ) 1 70 - 64 - 6,462 $ 3,248 (412 ) (2 ) (50 ) (30 ) 2,754 2,671 (5 ) 2,666 718 (15 ) (33 ) 670 231 4 (50 ) (344 ) (22 ) (181 ) 1,089 412 (4 ) - 52 409 22 68 - - 2,048 $ 18 18 345 345 - - 437 (313 ) (42 ) (339 ) (257 ) (800 ) - 313 - - 42 339 - - - (106 ) $ 6,869 (1,106 ) (2 ) (50 ) (30 ) (4 ) 5,677 5,681 (5 ) 5,676 3,440 (15 ) (33 ) (10 ) 3,382 653 (352 ) (387 ) (431 ) (50 ) (567 ) 194 (194 ) - (125 ) (125 ) (13 ) 13 - 5,748 1,106 352 194 (11 ) 452 431 68 64 - 8,404 1,062 156 70 43 (6 ) 125 21 14 14 65 1,564 4,686 950 282 151 (5 ) 327 410 54 50 (65 ) 6,840 Johnson & Johnson and Subsidiaries GAAP to Non-GAAP Reconciliation $ in Millions $ 7,998 (1,434 ) (13 ) 6,551 5,050 5,050 5,417 5,417 (152 ) 69 (227 ) (10 ) (13 ) (333 ) 10,762 1,434 (69 ) - 240 10 - 13 12,390 $ 6,964 (953 ) (23 ) (51 ) 5,937 5,518 5,518 1,324 37 1,361 130 (83 ) (111 ) (107 ) (50 ) (14 ) (235 ) 2,625 953 83 134 121 50 - 14 3,980 $ 23 23 433 433 - - (7,191 ) 6,923 (17 ) (285 ) 6,735 - (6,923 ) - 17 - - - (171 ) $ 14,985 (2,387 ) (23 ) (64 ) 12,511 11,001 11,001 6,741 37 6,778 (7,214 ) 6,909 (30 ) (351 ) (60 ) (27 ) (773 ) - - (80 ) (80 ) 81 (81 ) - 20,122 2,387 (6,909 ) 134 378 60 - 27 16,199 3,586 410 (1,544 ) 24 102 14 202 2,794 16,536 1,977 (5,365 ) 110 276 46 (202 ) 27 13,405 $ 6,973 (1,392 ) (6 ) 5,575 5,103 5,103 5,618 (17 ) 5,601 (70 ) (43 ) (194 ) (81 ) (48 ) (15 ) (50 ) (501 ) 10,428 1,392 43 194 81 48 15 - 73 - 12,274 $ 6,368 (792 ) (9 ) (50 ) (50 ) 5,467 5,253 (9 ) 5,244 1,364 (33 ) (60 ) 1,271 184 4 (70 ) (387 ) (44 ) (313 ) 2,609 792 (4 ) - 79 470 44 119 - - 4,109 $ 39 39 582 582 - - 2,954 (3,039 ) (82 ) (352 ) (519 ) (3,575 ) - 3,039 - - 82 352 - - - (102 ) $ 13,380 (2,184 ) (9 ) (50 ) (50 ) (6 ) 11,081 10,938 (9 ) 10,929 6,982 (33 ) (60 ) (17 ) 6,872 3,057 (3,078 ) (517 ) (411 ) (50 ) (999 ) 194 (194 ) - (334 ) (334 ) 151 (151 ) - 9,462 2,184 3,078 194 160 600 411 119 73 - 16,281 1,521 304 697 43 33 163 14 23 16 47 2,861 7,941 1,880 2,381 151 127 437 397 96 57 (47 ) 13,420 Media contact: media-relations@its.jnj.com Investor contact: investor-relations@its.jnj.com

Clinical ResultDrug ApprovalFinancial Statement

16 Jun 2025

·firstwordpharma.com

EHA25: J&J flexes deep, sustained responses with Talvey, Tecvayli combo in extramedullary myeloma

Johnson & Johnson's investigational combination of Talvey (talquetamab) and Tecvayli (teclistamab) showed deep and sustained responses in a mid-stage study of patients with extramedullary triple-class exposed (TCE) relapsed/refractory multiple myeloma (RRMM). The data were presented as a late-breaker at the European Hematology Association (EHA) congress on the weekend.While Talvey is a bispecific antibody targeting GPRC5D and CD-3, Tecvayli is a BCMA and CD3-directed bispecific. According to the company, the combination targets GPRC5D and BCMA in extramedullary disease — potentially overcoming treatment resistance mechanisms. “The…study reflects our strategy to harness…the combination of these dual bispecific antibodies, to help redefine potential outcomes for subsets of patients who are currently faced with a poor prognosis and limited options,” said Ester in't Groen, EMEA therapeutic area head for haematology at Johnson & Johnson Innovative Medicine. Data from the Phase Ib portion of the RedirecTT-1 study unveiled last year showed Talvey plus Tecvayli achieved a 79.5% overall response rate (ORR) and a 52.3% complete response or better (CR+) rate in patients with TCE RRMM; corresponding rates in the extramedullary disease subgroup were 61.1% and 33.3%.The Phase II part enrolled 90 patients with TCE RRMM presenting with true extramedullary disease, defined as soft tissue plasmacytomas without bone contact. Patient characteristics reflected heavily pretreated populations: 84.4% were triple-class refractory, 35.6% penta-drug refractory, and 20% had received prior BCMA CAR-T therapy.Results showed the combination of Talvey and Tecvayli demonstrated a 78.9% ORR, with 54.4% of patients achieving CR+. Durability metrics showed 66.2% of responders maintained response at median 13.4-month follow-up, whilst progression-free survival reached 61% at one year. Moreover, 64.1% of patients maintained response for a median of 13.8 months and 74.5% were alive at one year; median overall survival was not reached.Additionally, the combination maintained robust efficacy across subgroups, including patients with prior BCMA CAR-T exposure (83.3% response rate) and anti-FcRH5 bispecific antibody treatment (75% response rate). Meanwhile, adverse event profiles remained consistent with established monotherapy safety data, with no new safety signals identified. Grade 5 adverse events occurred in 11.1% of patients, with infections representing the primary fatal complication in five cases. Cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome presentations were predominantly low-grade.Both bispecifics are individually approved in the EU and US for adults with RRMM, who have previously received three and four lines of therapy, respectively.

Clinical ResultPhase 2ImmunotherapyDrug ApprovalCell Therapy

100 Deals associated with Talquetamab

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Refractory Multiple Myeloma	Japan	Janssen Pharmaceutical KK	24 Jun 2025
Relapse multiple myeloma	Japan	Janssen Pharmaceutical KK	24 Jun 2025
Multiple Myeloma	United States	Janssen Biotech, Inc.	09 Aug 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Peripheral Stem Cell Transplantation	Phase 2	United States	Janssen Scientific Affairs LLC	01 Nov 2025
Residual Neoplasm	Phase 2	United States	Johnson & Johnson	01 Jul 2025
Smoldering Multiple Myeloma	Phase 2	United States	Janssen Scientific Affairs LLC	04 Dec 2023
Hematologic Neoplasms	Phase 1	United States	Janssen Research & Development LLC	16 Dec 2017
Hematologic Neoplasms	Phase 1	Belgium	Janssen Research & Development LLC	16 Dec 2017
Hematologic Neoplasms	Phase 1	Netherlands	Janssen Research & Development LLC	16 Dec 2017
Hematologic Neoplasms	Phase 1	Spain	Janssen Research & Development LLC	16 Dec 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


MonumenTAL-1 (Pubmed \| Cancer)	Phase 1/2	Refractory Multiple Myeloma	118	Talquetamab 0.8 mg/kg	cpchyvbita(dybeqwkfqa) = ijzkxwcgbr xtcxcspbpn (ebmcpmuzoq ) View more	-	15 Jul 2025
NCT04586426 (REDIRECTT-1, EHA2025)	Phase 2	Relapse multiple myeloma	90	Talquetamab 0.8 mg/kg + Teclistamab 3.0 mg/kg	zeckmzalia(ebrwkxcvri) = vrpgmiaxtp mgeebkdrcq (zkwbqwhoff ) View more	Positive	03 Jun 2025
MonumenTAL-1 (ASCO2025)	Phase 1/2	Relapse multiple myeloma	-	Talquetamab 0.4 mg/kg weekly	sucrjsmikj(xwhteezsca) = most common adverse events (AE) keghrsabeg (hrizkkhdpc ) View more	Positive	30 May 2025
				Talquetamab 0.8 mg/kg every other week
BiTAL study (ASCO2025 \| EHA2025)	Not Applicable	Multiple Myeloma GPRC5D	215	Talquetamab (TAL) monotherapy	fmccibvzcj(anvfriyhmk) = paaxtnvoxn evcifkfzrs (pjsiaqvmte ) View more	Positive	30 May 2025
MajesTEC-1 (ASCO2025)	Not Applicable	Cytokine Release Syndrome CD3 \| BCMA \| GPRC5D	17	Teclistamab with prophylactic acetaminophen	zrawdofhnv(axwamcdvde) = developed in 72.1% of patients in MajesTEC-1 and 76% of patients in MonumenTAL-1 assapllnua (ehqngipkno ) View more	Positive	30 May 2025
				Teclistamab alone
NCT03399799 (MonumenTAL-1, EHA2025)	Phase 1/2	Relapse multiple myeloma	363	Talquetamab 0.4 mg/kg weekly	mfxxmasvrj(axfflnatds) = dlhxkychwu yquvdpxdbe (fexveqnsjk ) View more	Positive	22 May 2025
				Talquetamab 0.8 mg/kg every other week	mfxxmasvrj(axfflnatds) = jksjaqvzew yquvdpxdbe (fexveqnsjk ) View more
MonumenTAL-1 (EHA2025)	Not Applicable	Multiple Myeloma TCE	175	Talquetamab 0.4 mg/kg weekly	pfkgmwtfcd(zjoloptzkr) = gxwxghblhk yxufjykgdo (fvsjuspzwz ) View more	Positive	14 May 2025
				Talquetamab 0.8 mg/kg every other week	pfkgmwtfcd(zjoloptzkr) = japbhwwrkz yxufjykgdo (fvsjuspzwz ) View more
MonumenTAL-1 (EHA2025)	Not Applicable	Relapse multiple myeloma BCMA	75	Talquetamab 0.4 mg/kg weekly	lgznjxpgpd(mreyzvdddw) = lvsyhscjud ytohdwhtbu (bshhedxazp ) View more	Positive	14 May 2025
				TALQUETAMAB (Real-World Physician's Choice)	lgznjxpgpd(mreyzvdddw) = tltbkqwxhv ytohdwhtbu (bshhedxazp ) View more
TAL-1 (EHA2025)	Not Applicable	Multiple Myeloma GPRC5D	30	Talquetamab (Cohort I (Expanded Access Program))	kuykxsvalk(mbxuxaynqa) = CRS occurred in 15 pts (50%, 43.3% gr1, 3.3% gr2, 3.3% gr3) tsfilorgny (yfypcxzwzk ) View more	-	14 May 2025
				Talquetamab (Cohort II (Commercial Setting))
NCT05338775 (TRIMM-3, EHA2025)	Phase 1	Relapse multiple myeloma GPRC5D \| PD-1	44	Talquetamab 0.4 mg/kg + Cetrelimab 80 mg	zegoixlgag(caetitlqnb) = engqiglztb kjwgjfdcve (nbnovemfjf ) View more	Positive	14 May 2025
				Talquetamab 0.8 mg/kg + Cetrelimab 160 mg	zegoixlgag(caetitlqnb) = hrbbmyengq kjwgjfdcve (nbnovemfjf ) View more

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