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Last update 19 Feb 2025
Icotrokinra
Last update 19 Feb 2025
Overview
Basic Info
Drug Type Synthetic peptide |
Synonyms JNJ 67864238, JNJ-2113, JNJ-4238 + [7] |
Target |
Mechanism IL-23R inhibitors(Interleukin 23 Receptor inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Inactive Organization |
Drug Highest PhasePhase 3 |
First Approval Date- |
Regulation- |
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Structure/Sequence
Sequence Code 1311911322
Source: *****
Related
30
Clinical Trials associated with IcotrokinraNCT06807424
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of JNJ-77242113 for the Treatment of Biologic-experienced Participants With Active Psoriatic Arthritis
The purpose of this study is to evaluate the efficacy of icotrokinra compared to placebo in biologic-experienced participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
Start Date09 Jan 2025 |
Sponsor / Collaborator |
CTIS2024-515230-32-00
- 77242113PSO1009
Start Date09 Oct 2024 |
Sponsor / Collaborator- |
CTIS2023-510161-97-00
- 77242113PSO1007
Start Date19 Jun 2024 |
Sponsor / Collaborator- |
100 Clinical Results associated with Icotrokinra
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100 Translational Medicine associated with Icotrokinra
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100 Patents (Medical) associated with Icotrokinra
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3
Literatures (Medical) associated with Icotrokinra01 Nov 2024·JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
FRONTIER-2: A phase 2b, long-term extension, dose-ranging study of oral JNJ-77242113 for the treatment of moderate-to-severe plaque psoriasis
Article
Author: Ferris, Laura K ; Tyring, Stephen K ; Iaconangelo, Charles ; Ota, Takayuki ; Huang, Yu-Huei ; Shen, Yaung-Kaung ; Bissonnette, Robert ; Pink, Andrew E ; Bagel, Jerry ; Kokolakis, Georgios ; Li, Shu ; DeLozier, Amy M
BACKGROUND:
More patients with moderate-to-severe plaque psoriasis achieved responses with JNJ-77242113, a targeted oral peptide inhibiting interleukin-23 receptor signaling, versus placebo (PBO) at week (W)16 of the phase 2 FRONTIER-1 study.
OBJECTIVE:
FRONTIER-2, a long-term extension of FRONTIER-1, evaluated JNJ-77242113 through 1 year.
METHODS:
FRONTIER-1 participants received JNJ-77242113 at doses from 25 mg daily to 100 mg twice daily or PBO through W16. Patients completing FRONTIER-1 could enroll in FRONTIER-2 and continue JNJ-77242113 at the same dose through W52. Those on PBO crossed over to JNJ-77242113 100 mg daily for W16-52. Safety follow-up continued through W56.
RESULTS:
Most (89%) FRONTIER-1 patients continued to FRONTIER-2. Across outcomes, response rates were maintained from W16-52. The highest response rates generally occurred with JNJ-77242113 100 mg twice daily. At W52, 76% of patients achieved up to 75% improvement in Psoriasis Area and Severity Index (PASI75) with 100 mg twice daily; rates of clear or almost clear skin were 64% (PASI90), 74% (Investigator's Global Assessment 0/1), 40% (PASI100), and 43% (Investigator's Global Assessment 0). From W16-56, 59% of JNJ-77242113-treated patients had ≥1 adverse events. Serious adverse events, considered unrelated to treatment by investigators, occurred in 4% of patients.
LIMITATIONS:
The study was limited by the small number of patients in each treatment group and the descriptive nature of the longer-term data.
CONCLUSION:
Rates of skin clearance with JNJ-77242113 were durable to 1 year and no safety signals were identified.
08 Feb 2024·The New England journal of medicineQ1 · MEDICINE
An Oral Interleukin-23–Receptor Antagonist Peptide for Plaque Psoriasis
Q1 · MEDICINE
Article
Author: Ferris, Laura K ; Li, Shu ; Papp, Kim ; Bissonnette, Robert ; Kannan, Arun ; Shen, Yaung-Kaung ; Pinter, Andreas ; Miller, Megan ; Vender, Ronald ; Gerdes, Sascha ; Rich, Phoebe ; DeKlotz, Cynthia
BACKGROUND:
The use of monoclonal antibodies has changed the treatment of several immune-mediated inflammatory diseases, including psoriasis. However, these large proteins must be administered by injection. JNJ-77242113 is a novel, orally administered interleukin-23-receptor antagonist peptide that selectively blocks interleukin-23 signaling and downstream cytokine production.
METHODS:
In this phase 2 dose-finding trial, we randomly assigned patients with moderate-to-severe plaque psoriasis to receive JNJ-77242113 at a dose of 25 mg once daily, 25 mg twice daily, 50 mg once daily, 100 mg once daily, or 100 mg twice daily or placebo for 16 weeks. The primary end point was a reduction from baseline of at least 75% in the Psoriasis Area and Severity Index (PASI) score (PASI 75 response; PASI scores range from 0 to 72, with higher scores indicating greater extent or severity of psoriasis) at week 16.
RESULTS:
A total of 255 patients underwent randomization. The mean PASI score at baseline was 19.1. The mean duration of psoriasis was 18.2 years, and 78% of the patients across all the trial groups had previously received systemic treatments. At week 16, the percentages of patients with a PASI 75 response were higher among those in the JNJ-77242113 groups (37%, 51%, 58%, 65%, and 79% in the 25-mg once-daily, 25-mg twice-daily, 50-mg once-daily, 100-mg once-daily, and 100-mg twice-daily groups, respectively) than among those in the placebo group (9%), a finding that showed a significant dose-response relationship (P<0.001). The most common adverse events included coronavirus disease 2019 (in 12% of the patients in the placebo group and in 11% of those across the JNJ-77242113 dose groups) and nasopharyngitis (in 5% and 7%, respectively). The percentages of patients who had at least one adverse event were similar in the combined JNJ-77242113 dose group (52%) and the placebo group (51%). There was no evidence of a dose-related increase in adverse events across the JNJ-77242113 dose groups.
CONCLUSIONS:
After 16 weeks of once- or twice-daily oral administration, treatment with the interleukin-23-receptor antagonist peptide JNJ-77242113 showed greater efficacy than placebo in patients with moderate-to-severe plaque psoriasis. (Funded by Janssen Research and Development; FRONTIER 1 ClinicalTrials.gov number, NCT05223868.).
Scientific Reports
JNJ-77242113, a highly potent, selective peptide targeting the IL-23 receptor, provides robust IL-23 pathway inhibition upon oral dosing in rats and humans
Article
Author: Bhandari, Ashok ; Bains, Trpta ; Holland, M Claire ; Li, Shu ; Patrick, Aaron ; Sun, Chengzao ; Sherlock, Jonathan P ; Kannan, Arun ; Allen, Samantha J ; Polidori, David ; Li, Xinyi ; Cheng, Xiaoli ; Xue, Xiaohua ; Knight, Beverly ; Steele, Ruth ; Huie, Keith ; Kosoglou, Teddy ; Greving, Carrie ; Liu, David ; Patch, Raymond J ; Somani, Sandeep ; Towne, Jennifer ; Chang, Leon ; Fourie, Anne M ; Rodriguez, Michael A ; Modi, Nishit B
Abstract:
The interleukin (IL)-23 pathway is a pathogenic driver in psoriasis, psoriatic arthritis, and inflammatory bowel disease. Currently, no oral therapeutics selectively target this pathway. JNJ-77242113 is a peptide targeting the IL-23 receptor with high affinity (KD: 7.1 pM). In human cells, JNJ-77242113 potently and selectively inhibited proximal IL-23 signaling (IC50: 5.6 pM) without impacting IL-12 signaling. JNJ-77242113 inhibited IL-23–induced interferon (IFN)γ production in NK cells, and in blood from healthy donors and psoriasis patients (IC50: 18.4, 11 and 9 pM, respectively). In a rat trinitrobenzene sulfonic acid-induced colitis model, oral JNJ-77242113 attenuated disease parameters at doses ≥ 0.3 mg/kg/day. Pharmacologic activity beyond the gastrointestinal tract was also demonstrated. In blood from rats receiving oral JNJ-77242113, dose-dependent inhibition of ex vivo IL-23–stimulated IL-17A production was observed. In an IL-23–induced rat skin inflammation model, JNJ-77242113 inhibited IL-23–induced skin thickening and IL-17A, -17F and -22 gene induction. Oral dosing of JNJ-77242113 in healthy human volunteers inhibited ex vivo IL-23–stimulated IFNγ production in whole blood. Thus, JNJ-77242113 provided selective, systemic IL-23 pathway inhibition in preclinical models which translated to pharmacodynamic activity in healthy human volunteers, supporting the potential for JNJ-77242113 as a selective oral therapy for IL-23–driven immune-mediated diseases.
94
News (Medical) associated with Icotrokinra22 Jan 2025
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
24 Dec 2024
In the field of immunotherapy, the market for oral peptide therapies is gradually emerging. Recently, AbbVie announced that it has reached a final acquisition agreement with Nimble Therapeutics. This transaction will enable AbbVie to obtain Nimble's core assets, including its oral peptide IL-23 inhibitor project, which is in the preclinical research stage and aims to treat psoriasis, as well as an innovative pipeline of oral peptide candidates targeting various autoimmune diseases. Additionally, AbbVie will gain access to Nimble's peptide synthesis, screening, and optimization platform, which employs proprietary technology to accelerate the discovery and optimization of peptide candidates targeting multiple pathways.
AbbVie has long been active in the field of immunotherapy, and as its flagship product Humira faces patent expiration, the company is actively seeking new growth opportunities. This acquisition of Nimble Therapeutics not only enriches AbbVie's product pipeline but also strengthens its research and development capabilities in the field of oral peptide therapies.
In the realm of oral medications for psoriasis, Johnson & Johnson's JNJ-2113 shows best-in-class potential, leading over other competitors. Just last month, Johnson & Johnson announced that the ICONIC-LEAD clinical trial achieved top-line results, marking the imminent market entry of the world's first targeted oral peptide Icotrokinra that selectively blocks IL-23 receptors. In light of Johnson & Johnson's progress, AbbVie is making every effort to ensure it maintains a leading position in this competition.
Globally, there are over 125 million psoriasis patients, and this chronic disease requires long-term treatment, giving rise to a substantial treatment market. The global psoriasis market has reached $26.5 billion, and it is expected to maintain a 8.6% compound annual growth rate (CAGR) from 2022 to 2030. For the treatment of plaque psoriasis, 22 targeted therapies have been approved worldwide. Among these therapies, AbbVie and Johnson & Johnson are undoubtedly market leaders.
Oral medications are increasingly favored by long-term treatment patients due to their convenience. Current oral medications include PDE4 inhibitor apremilast, TYK2 allosteric inhibitor deucravacitinib, and JAK inhibitor upadacitinib. Moreover, numerous multinational companies are actively entering the oral medication market for psoriasis.
Johnson & Johnson's JNJ-2113 (Icotrokinra), as the world's first oral IL-23 receptor antagonist, relies on Protagonist Therapeutics' unique peptide technology platform, successfully overcoming challenges related to the low bioavailability, permeability, and stability of oral peptides, as well as gastrointestinal degradation. In the Phase III ICONIC-LEAD study, it demonstrated superior data compared to other oral competitors.
With strong efficacy data, Johnson & Johnson is highly confident in JNJ-2113, predicting that the drug could achieve a market potential of $5 billion. Observing Johnson & Johnson's breakthrough progress in the oral medication space for psoriasis, AbbVie is also stepping up its efforts to expand its product line and maintain its leadership in the treatment of autoimmune diseases.
AbbVie has turned its attention to Nimble Therapeutics, a biotechnology company focused on developing oral peptide therapies. Nimble's research achievements, particularly the IL-23R inhibitor, are noteworthy; this is a preclinical oral therapy designed to provide new treatment options for patients with psoriasis and inflammatory bowel disease (IBD). Importantly, this target shares the same profile as AbbVie's existing blockbuster injectable Risankizumab, indicating that Nimble's research results could synergize with AbbVie's current product line.
Nimble claims that its designed drugs not only inherit the strong activity of injectable IL-23 medications but also have an extended half-life. Furthermore, Nimble has disclosed two additional candidates targeting systemic severe myasthenia gravis and IBD, both of which are also in preclinical testing.
Through this acquisition, AbbVie will not only incorporate Nimble's product line but also gain advanced technology from this Madison, Wisconsin-based company for synthesizing, screening, and optimizing peptide candidates. This will provide powerful technical support for AbbVie in the field of oral peptide therapies, accelerating its R&D progress in this emerging area.
In fact, AbbVie’s acquisition of Nimble marks its third significant acquisition in the immunotherapy developer space this year. This series of consecutive acquisitions not only highlights AbbVie's proactive positioning in the field of immunotherapy but also reveals the company's urgency in maintaining its market leadership, especially against the backdrop of competitors like Johnson & Johnson making strides in oral medications for psoriasis.
The peptide industry is currently experiencing an unprecedented golden development period. Compared to small molecular chemical drugs, peptide drugs exhibit higher bioactivity and specificity; compared to biological drugs, they stand out due to low immunogenicity, high purity, and lower production costs. Overall, peptide drugs are favored for their high activity, low dosage, and low toxicity. Frost & Sullivan predicts that the global peptide drug market will grow from $60.7 billion in 2018 to $89.5 billion in 2023, and is expected to reach $189 billion by 2028.
When efficacy reaches a certain level, oral medications often become the treatment choice for patients due to their adherence advantages. However, due to the unique chemical and biological characteristics of peptide drugs, their oral delivery remains one of the significant challenges in the pharmaceutical field. Since the discovery of insulin, research on oral peptides has never ceased. Due to the poor permeability of peptide drugs and their susceptibility to degradation by proteases in the gastrointestinal tract, most available peptide drugs are in injectable form. However, the long-term repeated injection not only affects patients' quality of life but also increases the complexity of manufacturing and storage, ultimately leading to higher medical costs. Thus, although the development of oral peptide drugs has been a research hotspot in the pharmaceutical field, few successful products have emerged due to the numerous challenges in absorption.
With in-depth studies on the absorption mechanisms of peptides, innovative technologies developed by scientists are gradually breaking the barriers to peptide absorption in the gastrointestinal tract, and some oral peptide drugs have successfully hit the market. For example, the recently spotlighted Semaglutide is a GLP-1 peptide drug that traditionally has been administered via subcutaneous injection. With the help of the innovative SNAC absorption enhancer, the Semaglutide tablet (Rybelsus) has successfully overcome technical barriers, achieving a historic breakthrough in the oral administration of GLP-1 drugs, thus becoming the first truly oral peptide drug.
The active pharmaceutical ingredient (API) of Rybelsus is identical to that of its injectable counterpart and is modified with a fatty acid chain, additionally incorporating 300 mg of SNAC molecules. The inclusion of SNAC instantaneously raises the gastric pH, promoting transcellular absorption through the gastric mucosa at specific concentrations. In human NCI-N87 gastric epithelial cell models, adding SNAC increased the absorption capacity of gastric epithelial cells by 100 times. After entering the market, Rybelsus also performed impressively, with demand so great that it led to supply shortages. In the first half of 2024, Rybelsus achieved sales of $1.587 billion, representing a 32% year-over-year growth.
Equally noteworthy is the Israeli pharmaceutical company Chiasma Inc., which successfully developed the oral capsule Mycapssa through innovative formulation and received approval in the U.S. in 2020 via the 505(b)(2) regulatory pathway. Mycapssa is the first and only approved oral somatostatin analog capsule for treating acromegaly, offering patients a new treatment option. The transient permeability enhancer (TPE™) technology employed by Chiasma provides critical technical support for developing oral peptide drugs.
Merck has also recognized the potential of oral peptides. In January 2024, Merck signed a $220 million collaboration agreement with Unnatural Products. Through this collaboration, Merck intends to leverage Unnatural Products' technology to develop cyclic peptide candidates, primarily targeting the challenging oncology field. Merck has previously likened cyclic peptides to "Goldilocks," as their molecular size falls between small molecules and biologics, offering numerous unique advantages. Previously, Merck launched the Phase III clinical project for MK-0616, a cyclic peptide that binds to PCSK9. Currently, PCSK9-targeted therapies can only be administered via injection, and the cost-effectiveness issues related to using biologics to lower cholesterol have yet to be effectively addressed. Developing an oral PCSK9 inhibitor is a goal in this field, and the R&D of MK-0616 cyclic peptide is expected to make significant breakthroughs in this area.
According to a report by MARKET MONITOR GLOBAL, INC (MMG), the global oral peptide therapeutic drug market was approximately $1886.4 million in 2023, with an expected annual compound growth rate (CAGR) of 15.8% over the next six years, reaching $7843.2 million by 2030. Industry perspectives generally indicate that the treatment market for autoimmune diseases is experiencing rapid growth. As the technology for oral peptide therapies continues to advance and the market expands quickly, AbbVie is solidifying its R&D position in the oral peptide field through the acquisition of Nimble Therapeutics. Whether AbbVie can reclaim the title of "King of Immunology" and continue leading innovation in the treatment of autoimmune diseases will be closely monitored by Pharmaceutical Economic News.
Phase 3Clinical ResultAcquisitionDrug ApprovalImmunotherapy
23 Dec 2024
Bristol Myers Squibb’s bet on TYK2 continued to pay off Monday, as Sotyktu passed two more Phase 3 tests in psoriatic arthritis, the company announced.
Both pivotal trials met their primary endpoint, with Sotyktu inducing at least a 20% improvement in patient symptoms over placebo after 16 weeks as measured by the American College of Rheumatology response criteria (ACR20). Specific data and BMS’ next regulatory steps were not immediately clear.
Sotyktu remains at the front of the pack in an emerging suite of TYK2 inhibitors, with competition soon expected from Takeda and the startup Alumis. Sotyktu’s first approval in plaque psoriasis came in September 2022, whereas both Takeda and Alumis’ programs have not received any approvals and are still in Phase 3 for that indication.
But other modalities could soon challenge Sotyktu across immunological conditions. Johnson & Johnson is expected to test its oral IL-23 drug
icotrokinra
(previously JNJ-2113) against Sotyktu in two Phase 3 studies, with results anticipated in the first half of next year.
Each of BMS’ psoriatic arthritis trials enrolled about 700 patients. The first trial looked at Sotyktu in individuals who had not previously received a biologic antirheumatic drug, while the second included such patients and also those who had taken a TNF-alpha inhibitor.
The ACR20 criteria include tender and swollen joints, physician assessments and patient-reported pain, among others.
Phase 3Drug ApprovalClinical Result
100 Deals associated with Icotrokinra
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R&D Status
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Arthritis, Psoriatic | Phase 3 | US | 31 Dec 2024 | |
| Arthritis, Psoriatic | Phase 3 | CN | 31 Dec 2024 | |
| Arthritis, Psoriatic | Phase 3 | JP | 31 Dec 2024 | |
| Arthritis, Psoriatic | Phase 3 | AR | 31 Dec 2024 | |
| Arthritis, Psoriatic | Phase 3 | AU | 31 Dec 2024 | |
| Arthritis, Psoriatic | Phase 3 | BR | 31 Dec 2024 | |
| Arthritis, Psoriatic | Phase 3 | BG | 31 Dec 2024 | |
| Arthritis, Psoriatic | Phase 3 | CA | 31 Dec 2024 | |
| Arthritis, Psoriatic | Phase 3 | CZ | 31 Dec 2024 | |
| Arthritis, Psoriatic | Phase 3 | DK | 31 Dec 2024 |
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Clinical Result
Clinical Result
Indication
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Evaluation
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| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Phase 3 | - | gygohscwyf(lhftbxpsbb) = xqcuhktldx cfxwwavihm (imgtlklvcw ) Met View more | Positive | 18 Nov 2024 | |||
Placebo | gygohscwyf(lhftbxpsbb) = jabldbozra cfxwwavihm (imgtlklvcw ) Met View more | ||||||
Phase 3 | - | cwzttaxzmt(noxbbzqgyo) = positive topline results from the Phase 3 ICONIC-TOTAL study showed once-daily icotrokinra met the primary endpoint of IGA of 0/1 at week 16 compared to placebo. jyhgqakrnw (brfwcanklc ) Met | Positive | 18 Nov 2024 | |||
Placebo | |||||||
Phase 2 | 227 | thytduemeo(ujmyryixdw) = movdgijvub yhqgcczhiy (aaowtueocj ) View more | Positive | 09 Mar 2024 | |||
Phase 2 | 255 | JNJ-77242113 25 mg once daily | oyxejgmgrx(iycxhshfrj) = kgaizqlzij yypmxtsltb (jjargqdduq ) Met | Positive | 08 Feb 2024 | ||
JNJ-77242113 25 mg twice daily | oyxejgmgrx(iycxhshfrj) = acdhqzfgdi yypmxtsltb (jjargqdduq ) Met | ||||||
Phase 2 | 255 | vyqscyrpoo(yatnkwxtzd) = cmbmdagxur hhqrfswueq (zrvudmomuo ) Met View more | Positive | 04 Jul 2023 | |||
vyqscyrpoo(yatnkwxtzd) = tlahxyimeo hhqrfswueq (zrvudmomuo ) Met View more | |||||||
Phase 2 | 48 | Placebo (Placebo) | jmpyhnnizb(wrwxhsyxbg) = klsuohjfdv ncnpbxbmrp (hhdvjdqfgo, cdivihnpin - ezhqcianrj) View more | - | 09 Dec 2022 | ||
(JNJ-67864238) | jmpyhnnizb(wrwxhsyxbg) = xoxttotlwm ncnpbxbmrp (hhdvjdqfgo, ssyxarvbgq - bemiwqeztl) View more | ||||||
Not Applicable | - | - | cjcdapwbpx(qymelwbspr) = hgdoltsgrq uurpdkvhgq (scstwekvzs, 0.81) View more | - | 01 Oct 2019 | ||
cjcdapwbpx(qymelwbspr) = yxajqeuvjk uurpdkvhgq (scstwekvzs, 1.23) View more |
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