CD38 inhibitors(Lymphocyte differentiation antigen CD38 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Antibody-dependent cellular phagocytosis (ADCP) effects

Therapeutic Areas

NeoplasmsImmune System DiseasesCardiovascular Diseases+ [6]

Active Indication

Immunoglobulin Light-Chain AmyloidosisMultiple MyelomaSmoldering Multiple Myeloma+ [21]

Inactive Indication

Adult Lymphoblastic LymphomaExtranodal NK-T-Cell LymphomaFollicular Lymphoma+ [10]

Originator Organization

Janssen Global Services LLC

Active Organization

Janssen Pharmaceutica NVJanssen Research & Development LLC

Genentech, Inc.

+ [16]

Inactive Organization

Janssen-Cilag GmbH

Drug Highest PhaseApproved

First Approval Date

US (16 Nov 2015),

Multiple Myeloma

RegulationBreakthrough Therapy (US), Fast Track (US), Accelerated Approval (US), Orphan Drug (US), Orphan Drug (EU), Priority Review (CN), Orphan Drug (KR), Orphan Drug (GB), Priority Review (JP), Conditional marketing approval (CN), Orphan Drug (JP)

Structure/Sequence

Sequence Code 9075449L

Source: *****

Sequence Code 9946743H

Source: *****

307

Clinical Trials associated with Daratumumab

NCT06785415

/ Not yet recruitingPhase 1/2IIT

Phase 1/2 Trial of Elotuzumab, Daratumumab, Iberdomide, and Dexamethasone for Relapsed Multiple Myeloma

This phase I/II trial tests the safety, side effects, and best dose of iberdomide and how well it works in combination with daratumumab, elotuzumab, and dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement (relapsed). Immunotherapy with iberdomide, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Elotuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving iberdomide in combination with daratumumab, elotuzumab, and dexamethasone may be safe, tolerable and/or effective in patients with relapsed multiple myeloma.

Start Date03 Mar 2025

Sponsor / Collaborator

Mayo Clinic

NCT06615479

/ RecruitingPhase 3

A Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of BMS-986393, a GPRC5D-directed CAR-T Cell Therapy, Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-refractory Multiple Myeloma

The purpose of this study is to compare the efficacy and safety of BMS-986393 versus standard regimens in adult participants with Relapsed or Refractory and Lanalidomide-refractory Multiple Myeloma.

Start Date15 Feb 2025

Sponsor / Collaborator

Juno Therapeutics, Inc.

[+1]

NCT06622005

/ Not yet recruitingPhase 1IIT

Phase 1 Trial of SX-682, a CXCR 1/2 Inhibitor, in Combination With Standard of Care Treatment in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)

This phase I trial tests the safety and side effects of SX-682 in combination with standard of care treatment carfilzomib, daratumumab-hyaluronidase, and dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). SX-682 works by blocking certain sites on cells that suppress the ability of the immune system to destroy tumor cells. Blocking those specific sites allows other cells of the immune system to become "free" to kill tumor cells. Carfilzomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and tumor cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill tumor cells, while hyaluronidase helps to deliver daratumumab to CD38-expressing tumor cells through a subcutaneous injection. Dexamethasone is in a class of medications called corticosteroids. It is known to kill myeloma cells and is also used to reduce inflammation and lower the body's immune response to monoclonal antibodies like dratumumab and help lessen its side effects. Giving SX-682 in combination with carfilzomib, daratumumab-hyaluronidase and dexamethasone may be safe and tolerable in treating patients with relapsed or refractory multiple myeloma

Start Date01 Feb 2025

Sponsor / Collaborator

Roswell Park Comprehensive Cancer Center

100 Clinical Results associated with Daratumumab

100 Translational Medicine associated with Daratumumab

100 Patents (Medical) associated with Daratumumab

1,805

Literatures (Medical) associated with Daratumumab

31 Dec 2025·ANNALS OF MEDICINE

Serum free light chain level-based and non-fixed cycle daratumumab treatment strategy for patients with light chain amyloidosis

Article

Author: Huang, Xianghua ; Guo, Jinzhou ; Chen, Wencui ; Li, Zhen ; Zhao, Liang ; Ren, Guisheng

BACKGROUND:

In recent years, daratumumab (DARA) has gained widespread use in the treatment of systemic light chain (AL) amyloidosis. In this study, we assessed the efficacy and safety of a DARA treatment strategy based on serum free light chain (sFLC) levels and non-fixed cycles.

METHODS:

The study included 123 patients with Al amyloidosis who received DARA at our center between July 2020 and September 2023. All patients received the standard DARA treatment (16 mg/kg weekly for four weeks) during the first course. Subsequent treatments were adjusted based on sFLC levels and the physician's judgment.

RESULTS:

The results demonstrated an impressive overall hematologic response rate (ORR) of 94.3%, with a hematologic very good partial response (VGPR) and complete response (CR) rate of 84.5%. Median time to best hematologic response was 1 months. Cardiac and renal response rates were 39.3% and 60.3%, respectively. Thirty patients experienced grade 1/2 infusion-related reactions after the first infusion. The rate of grade 3/4 adverse events was 21%. The most common adverse events of grade 3 or 4 were pulmonary infection (6.5%), neutropenia and lymphocytopenia (5.7%), elevated transaminases (1.6%), acute kidney injury (1.6%). After a median follow-up of 13 months (range 1-38), The 1-year OS and PFS estimates were 96.5% and 84.4%, respectively.

CONCLUSION:

These findings indicate that the sFLC levels based and non-fixed cycle DARA strategy is an efficacious and safe treatment strategy in both newly diagnosed and relapsed/refractory AL amyloidosis.

01 Mar 2025·PEDIATRIC BLOOD & CANCER

Utility of Daratumumab as Bridging Therapy in De Novo T‐Cell Acute Lymphoblastic Lymphoma

Letter

Author: Kotecha, Rishi S. ; Holzmann, Jonathan J.

01 Mar 2025·SEMINARS IN IMMUNOLOGY

Enhancing complement activation by therapeutic anti-tumor antibodies: Mechanisms, strategies, and engineering approaches

Review

Author: Dijkman, Karin ; Trouw, Leendert A ; Zom, Gijs G ; Ovcinnikovs, Vitalijs ; Beurskens, Frank J

The complement system plays an integral role in both innate and adaptive immune responses. Beyond its protective function against infections, complement is also known to influence tumor immunity, where its activation can either promote tumor progression or mediate tumor cell destruction, depending on the context. One such context can be provided by antibodies, with their inherent capacity to activate the classical complement pathway. In recent years, our understanding of the mechanisms governing complement activation by IgG and IgM antibodies has expanded significantly. At the same time, preclinical and clinical studies on antibodies such as rituximab, ofatumumab, and daratumumab have provided evidence for the role of complement in therapeutic success, encouraging strategies to further enhance its activity. In this review we examine the main determinants of antibody-mediated complement activation, highlighting the importance of antibody subclass, affinity, valency, and geometry of antigen engagement. We summarize the evidence for complement involvement in anti-tumor activity and challenges of accurately estimating the extent of its contribution to therapeutic efficacy. Furthermore, we explore several engineering approaches designed to enhance complement activation, including increased Fc oligomerization and C1q affinity, bispecific C1q-recruiting antibodies, IgG subclass chimeras, as well as antibody and paratope combinations. Strategies targeting membrane-bound complement regulatory proteins to overcome tumor-associated complement inhibition are also discussed as a method to boost therapeutic efficacy. Finally, we highlight the potential of complement-dependent cellular cytotoxicity (CDCC) and complement-dependent cellular phagocytosis (CDCP) as effector mechanisms that warrant deeper investigation. By integrating advances in antibody and complement biology with insights from efforts to enhance complement activation in therapeutic antibodies, this review aims to provide a comprehensive framework of antibody design and engineering strategies that optimize complement activity for improved anti-tumor efficacy.

493

News (Medical) associated with Daratumumab

23 Jan 2025

·www.businesswire.com

CORRECTING and REPLACING Exicure, Inc. Announces Purchase Agreement with GPCR Therapeutics Inc.

CHICAGO--( BUSINESS WIRE )--Please replace the release dated January 22, 2025 with the following corrected version due to multiple revisions. The updated release reads: EXICURE, INC. ANNOUNCES PURCHASE AGREEMENT WITH GPCR THERAPEUTICS INC. Exicure, Inc. (Nasdaq: XCUR, “the Company”, “Exicure”), today announced that on January 19, 2025, Exicure Inc. (“the Company”) entered into a Share Purchase Agreement with GPCR Therapeutics Inc., a Korean corporation (“GPCR”), pursuant to which the Company acquired from GPCR all of the issued and outstanding equity securities of GPCR Therapeutics USA Inc., a California corporation (“GPCR USA”). The transactions completed under the Share Purchase Agreement closed concurrently with execution. GPCR USA was, until immediately prior to closing under the Share Purchase Agreement, a wholly owned subsidiary of GPCR. In connection with the closing of the Share Purchase Agreement, the Company and GPCR entered into a License and Collaboration Agreement (“L&C Agreement”) to further develop and commercialize GPCR’s technologies related to certain intellectual properties and patents. The L&C Agreement requires the Company to make milestone payments to GPCR upon the achievement of specific milestone events relating to clinical trials, marketing authorizations, and net sales, as well as for the Company to pay a recurring royalty payment based on at least 10% of net sales, as set forth in the L&C Agreement. About GPCR USA, Inc. GPCR USA is a biotech company that is currently led by Dr. Pina Cardarelli, the CSO and president of GPCR USA. The company has an ongoing Phase 2 clinical trial focused on blood cancer patients, particularly those eligible for hematopoietic stem cell transplantation (HSCT). The trial involves the combined administration of G-CSF, GPC-100 (Burixafor) and propranolol. Per Dr. Cardarelli, "Two additional patients will receive treatment in January 2025. GPCR USA plans to complete the administration of GPC-100 to 20 patients by the end of April and aim to announce the clinical trial results by September." In December of last year, GPCR USA presented results at the American Society of Hematology conference evaluating the impact of inhibiting CXCR4 and ADRB2 (beta-2 adrenergic receptor) on stem cell mobilization. Interim data from 10 patients for burixafor in combination with propranolol and G-CSF is promising. Results suggest that the treatment regimen can mobilize CD34 + stem cells sufficiently for autologous stem cell transplant. Notably, burixafor allowed for same day administration of both mobilizing agent and leukapheresis. This fast kinetics of mobilization is differentiated from the FDA approved plerixafor or motixafortide, which require overnight pre-treatment prior to leukapheresis. The median times to neutrophil and platelet engraftment, 11 and 14 days respectively, are slightly less than what has been observed for standard of care. Importantly, 100% of the patients met the primary objective and the combination regimen exhibited excellent safety profiles in patients receiving the new front line blood cancer drug, Daratumumab. Dr. Cardarelli stated, "After completing patient treatment, we will conduct follow-up observations until July and then start data analysis," adding that positive results from the GPC-100 trial could have a beneficial impact on attracting additional investment and enhancing corporate value. Currently, the ongoing clinical trials have met all primary end points and are at the stage of deciding whether to proceed to Phase 3. A proposed double-blind clinical trial comparing the mobilization agent Plerixafor with GPC-100 is under discussion. Additionally, research has shown that the combination of GPC-100 and propranolol increases the number of specific T cells, which are favorable for enhancing CAR-T (Chimeric Antigen Receptor T-cell) response rates, and relevant papers are being published. Thus, this could assist Exicure in expanding its additional pipeline for cell and gene therapies. Dr. Cardarelli suggested that in the future, it will be essential to prioritize discussions with various partners based on the likelihood of success and high return on investment. She concluded, "If the hypotheses presented to GPCR USA are validated, there may be potential G-Protein Coupled Receptor targets that could be applicable to various diseases. We are considering steps such as establishing collaborations with companies possessing antibody manufacturing technologies, testing those technologies, and conducting joint research on multiple G-Protein Coupled Receptors.” Dr. Cardarelli was an inventor of the CXCR4 antibody, Ulocuplumab developed by BMS, and in 2019 she joined GPCR Therapeutics evaluating the combination of CXCR4 and ADRB2. She later served as the Chief Scientific Officer (CSO) of GPCR USA, contributing to the establishment of GPCR USA, talent acquisition, formation of a scientific advisory board, and the introduction of cell analysis and high-throughput screening technologies. She also successfully designed clinical trials for GPC-100 and secured FDA orphan drug designation. About Exicure, Inc. Exicure, Inc. is an early-stage biotechnology company focused on developing nucleic acid therapies targeting ribonucleic acid against validated targets. Following its recent restructuring and suspension of clinical and development activities, the Company is exploring strategic alternatives to maximize stockholder value, both with respect to its historical biotechnology assets and more broadly. For further information, see www.exicuretx.com . Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Forward looking statements are those which are not historical in nature. They are often identified by their inclusion of words such as “will,” “anticipate,” “estimate,” “plan,” “should,” “expect,” “believe,” “intend” and similar expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual outcomes to differ materially from the outcomes expressed or implied by this report. Such risks include, among others, the accuracy of projections, targets, or plans, the possibility of listing deficiencies, and the risk that Nasdaq will ultimately delist the Company’s common stock. All such factors are difficult to predict and may be beyond the Company’s control. The Company undertakes no obligation and does not intend to update or revise any forward-looking statements contained herein, except as required by law or regulation. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this report.

Clinical ResultLicense out/inASHPhase 2Orphan Drug

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

22 Jan 2025

·www.biopharmadive.com

J&J oncology sales grow, but shares slide on outlook

Dive Brief:Johnson & Johnson on Wednesday reported modestly higher-than-expected earnings for the fourth quarter, while cautioning that unfavorable currency exchange rates would temper sales growth this year.Adjusted earnings per share reached $2.04 in the fourth quarter, higher than the Wall Street consensus of $2.01 and Leerink Partners estimate of $1.96, Leerink analyst David Risinger wrote in a note to clients. The companys sales rose 5.3% to $22.5 billion during the quarter, in line with estimatesFull-year 2024 revenue increased to $88.8 billion from $85.2 billion in 2023. For this year, J&J expects revenue to climb to between $89.2 billion and $90 billion, with a mid-point of $89.6 billion, less than the consensus estimate of $91.1 billion. Shares of the company dropped about 3% in early trading Wednesday, even as the overall market rose.Dive Insight:CEO Joaquin Duato is looking to newer medicines to drive J&Js sales growth as the company fights through generic competition for its second-best selling drug, Stelara. Worldwide sales of Stelara dropped 15% to $2.3 billion in the fourth quarter, with most of the decline coming from overseas, where copycat competition already has a toehold. In the U.S., Amgen recently launched the first biosimilar of Stelara and more are on the way.Even so, J&J is poised for sustained growth through this decade, Duato said. I cannot think of any other company that would be able to deliver growth through the first year of losing exclusivity of a multibillion-dollar product, Duato told analysts on a conference call.That growth will depend in large part on the continued success of the companys cancer medicines, led by Darzalex. Sales of the drug jumped 21% to $3.1 billion in the fourth quarter. At the same time, J&Js Carvykti, a CAR-T treatment for multiple myeloma, came close to breaking $1 billion in sales for the year. J&J will also be looking for growth from newer medicines including Tecvayli and Talvey.Outside of oncology, J&Js depression treatment Spravato brought in sales of $1.1 billion for the year, a 56% increase from the previous year. And the drug will benefit in 2025 from an expanded Food and Drug Administration approval in people with treatment-resistant depression.J&J also plans to expand its psychiatric offerings with the $14.6 billion acquisition of Intra-Cellular Therapies announced last week. Intra-Cellular sells a drug called Caplyta for schizophrenia and bipolar disorder and is looking to expand its use for patients with major depressive disorder. '

AcquisitionCell Therapy

100 Deals associated with Daratumumab

External Link

KEGG	Wiki	ATC	Drug Bank
D10777	Daratumumab	L01XC24	DB09331

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Immunoglobulin Light-Chain Amyloidosis	EU	Janssen-Cilag International NV	20 May 2016
Immunoglobulin Light-Chain Amyloidosis	IS	Janssen-Cilag International NV	20 May 2016
Immunoglobulin Light-Chain Amyloidosis	LI	Janssen-Cilag International NV	20 May 2016
Immunoglobulin Light-Chain Amyloidosis	NO	Janssen-Cilag International NV	20 May 2016
Multiple Myeloma	US	Janssen Biotech, Inc.	16 Nov 2015

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Smoldering Multiple Myeloma	NDA/BLA	EU	Johnson & Johnson	08 Nov 2024
Residual Neoplasm	Phase 3	US	Janssen Research & Development LLC	26 Apr 2019
Residual Neoplasm	Phase 3	CA	Janssen Research & Development LLC	26 Apr 2019
Amyloidosis	Phase 3	US	Janssen Research & Development LLC	10 Oct 2017
Amyloidosis	Phase 3	US	Xian-Janssen Pharmaceutical Ltd.	10 Oct 2017
Amyloidosis	Phase 3	JP	Janssen Research & Development LLC	10 Oct 2017
Amyloidosis	Phase 3	JP	Xian-Janssen Pharmaceutical Ltd.	10 Oct 2017
Amyloidosis	Phase 3	AU	Xian-Janssen Pharmaceutical Ltd.	10 Oct 2017
Amyloidosis	Phase 3	AU	Janssen Research & Development LLC	10 Oct 2017
Amyloidosis	Phase 3	BE	Janssen Research & Development LLC	10 Oct 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04151667 (CTgov)	Phase 2	Multiple Myeloma	33	Daratumumab Injection+Dexamethasone Oral (A: Daratumumab & Dexamethasone)	wvbldargjb(kidnjbgofs) = vpbgqmcqly rjtoxwtewb (ktyfeltimg, wvfqmyxzsu - pzszwatqje) View more	-	30 Dec 2024
				Lenalidomide Pill+Daratumumab Injection+Dexamethasone Oral (B: Daratumumab, Dexamethasone and Lenalidomide)	wvbldargjb(kidnjbgofs) = lxpwyebgbo rjtoxwtewb (ktyfeltimg, hdgbenzpaa - jybxupiqei) View more
NCT03710603 (PERSEUS, CTgov)	Phase 3	Multiple Myeloma	709	Lenalidomide+Velcade+dexamethasone (Velcade Lenalidomide Dexamethasone (VRd))	ymhbbfsfmf(phedecbwvz) = hdrljnoxnx xjhnooopjv (dzsfwdfchg, uykstjqeeb - rdqpmakcpe) View more	-	24 Dec 2024
				Lenalidomide+Daratumumab+Velcade+dexamethasone (Daratumumab + VRd (D-VRd))	ymhbbfsfmf(phedecbwvz) = uzfrgepeww xjhnooopjv (dzsfwdfchg, iyxvgldvod - valdgrtzxc) View more
NCT03301220 (AQUILA, ASH2024) Manual	Phase 3	Smoldering Multiple Myeloma	390	Daratumumab	noolrazcaf(vdhstfaite) = jmiixfjjtp vfkwtmrtek (mtiedhtunb ) View more	Positive	09 Dec 2024
				Active Monitoring	noolrazcaf(vdhstfaite) = lsrmmutjqo vfkwtmrtek (mtiedhtunb ) View more
NCT03201965 (Andromeda, ASH2024) Manual	Phase 3	Immunoglobulin Light-Chain Amyloidosis First line	388	Daratumumab (DARA) + Bortezomib, Cyclophosphamide, and Dexamethasone (VCd)	xrioibxpoj(muyolzltns) = umqrpvhzrs zmukmcyxhc (pdyhskbfqc ) View more	Positive	09 Dec 2024
				Bortezomib, Cyclophosphamide, and Dexamethasone (VCd)	xrioibxpoj(muyolzltns) = khbbaqvpto zmukmcyxhc (pdyhskbfqc ) View more
ASH2024	Not Applicable	Multiple Myeloma	-	Daratumumab (Transplant Eligible (TE) patients)	vhihbfjgbd(bqmiscekrt) = eqtrbbbdjt pauefrnxjw (qwmmxofqaz, -6.1 to -0.9) View more	-	09 Dec 2024
				Daratumumab (Transplant Ineligible (TIE) patients)	vhihbfjgbd(bqmiscekrt) = kxozeayini pauefrnxjw (qwmmxofqaz, -7.6 to -2.1) View more
ASH2024	Not Applicable	Multiple Myeloma	-	Daratumumab Plus Lenalidomide (D-R)	utdbkjolad(ddvdpvjuus) = nslkkutyxw ernrqcltlu (qleebuhuwx ) View more	-	08 Dec 2024
				Lenalidomide (R)	utdbkjolad(ddvdpvjuus) = mmwmjopbfc ernrqcltlu (qleebuhuwx ) View more
ASH2024	Not Applicable	Multiple Myeloma	-	Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd)	izsawwdeta(qwkubrramf) = hzevjsjpjf ybhantlspu (senrhczypr ) View more	-	08 Dec 2024
				DVRd-DR	izsawwdeta(qwkubrramf) = mqaantekss ybhantlspu (senrhczypr ) View more
NCT03652064 (CEPHEUS, ASH2024) Manual	Phase 3	Multiple Myeloma	395	Daratumumab (DARA) + Bortezomib, Lenalidomide and Dexamethasone	godtlowplz(uuiakxeiwv) = sexauhnvnl izgmmdjeff (jflgyagqus ) View more	Positive	07 Dec 2024
				Bortezomib, Lenalidomide and Dexamethasone (VRd)	godtlowplz(uuiakxeiwv) = lumrcujbqz izgmmdjeff (jflgyagqus ) View more
ESMO_ASIA2024	Not Applicable	Multiple Myeloma	-	Subcutaneous Daratumumab	mibiplycwz(uhvcbvomjb) = In the additional six-month investigation period, new grade 1-2 anemia and thrombocytopenia were observed in three patients (30.0%) hvphelcfxo (sqrfipiwmb ) View more	Positive	07 Dec 2024
ASH2024	Not Applicable	Multiple Myeloma	-	DARA-sensitive patients	uxbakdshpu(tilytgvinj) = wzqquqoaem zgfrgvdfry (ahqxhzftgz, 5.5 - 9.5) View more	-	07 Dec 2024
				DARA-refractory patients	uxbakdshpu(tilytgvinj) = qxigzxifaj zgfrgvdfry (ahqxhzftgz, 3.8 - 23.5) View more

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