This phase I trial evaluates the effects of apalutamide, compared to placebo, on epidermal growth factor receptor (EGFR) protein expression in patients with non-muscle invasive bladder cancer. Apalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Previous studies have suggested that expression of a protein called EGFR on tumor cells is related to bladder cancer disease progression. This trial may help doctors evaluate if apalutamide has any effect on EGFR expression in patients with non-muscle invasive bladder cancer.

Start Date01 Nov 2025

Sponsor / Collaborator

National Cancer Institute

NCT07086651

/ RecruitingNot Applicable

Real-world Clinical Outcomes With Androgen Receptor Pathway Inhibitors (ARPIs) in Metastatic Castration-sensitive Prostate Cancer (mCSPC) in the Flatiron Health Electronic Health Records (EHR) Database

The purpose of this study is to learn about how long apalutamide and enzalutamide are taken by men to treat mCSPC.
Prostate cancer is one of the most common cancers in men. The prostate is a gland in the male body that helps make semen. Metastatic cancer is a cancer that has spread to other parts of the body. Castration-sensitive prostate cancer means the cancer is being controlled by keeping the testosterone levels as low as would be expected if the testicles were removed by surgery.
This is a real-world study, not a clinical study. This means that researchers will look at what happens when men receive the treatments prescribed by their own doctor as part of their usual healthcare treatment. In this study, researchers will use information from cancer clinics (Flatiron Health electronic health records).
The study will include patients' information from the database for men who:
* Were identified to have mCSPC.
* Started treatment with apalutamide or enzalutamide (index date) for mCSPC.
* Were 18 years of age or older on the index date. Men in this study will be taking apalutamide or enzalutamide for treatment of their mCSPC. The study will compare how long men take apalutamide or enzalutamide. This study will use patient information from cancer clinics. Information from start of apalutamide or enzalutamide treatment until information is available in the database will be used to describe how long patients receive treatment.

Start Date21 Jul 2025

Sponsor / Collaborator

Pfizer Inc.

[+1]

NCT06592924

/ RecruitingPhase 3IIT

A Randomized Phase III Clinical Trial for the Addition of Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response

This study is being done to answer the following question: can the chance of prostate cancer growing or spreading be lowered by adding a drug to the usual combination of drugs?
This study would like to find out if this approach is better or worse than the usual approach for prostate cancer.
The usual approach for patients who are not in a study is hormone treatment with Androgen Deprivation Therapy (ADT) and Androgen-Receptor Pathway Inhibitor (ARPI).

Start Date28 May 2025

Sponsor / Collaborator

Canadian Cancer Trials Group

[+4]

100 Clinical Results associated with Apalutamide

100 Translational Medicine associated with Apalutamide

100 Patents (Medical) associated with Apalutamide

787

Literatures (Medical) associated with Apalutamide

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Healthcare resource utilization and costs among patients with metastatic castration-sensitive prostate cancer initiated on apalutamide or enzalutamide in the United States (2019–2023)

Article

Author: Khilfeh, Ibrahim ; Bilen, Mehmet A. ; Joshi, Kruti ; Du, Shawn ; Rossi, Carmine ; Lowentritt, Benjamin ; Shore, Neal D. ; Pilon, Dominic ; Wong, Gordon ; Kinkead, Frederic ; Burbage, Sabree

AIMS:

This retrospective longitudinal cohort study compared healthcare resource utilization (HRU) and costs among patients with metastatic castration (hormone)-sensitive prostate cancer who initiated apalutamide or enzalutamide, two androgen receptor pathway inhibitors (ARPIs) that have demonstrated efficacy in the treatment of advanced prostate cancer in phase 3 clinical trials.

METHODS:

Linked patient-level data from a practice-related clinical urology database and an administrative claims database in the United States (1 January 2016-31 December 2023) were used. Per-patient-per-month (PPPM) HRU and cost outcomes were compared between the apalutamide and enzalutamide cohorts during the observation period (i.e. from ARPI initiation until continuous insurance eligibility end) after inverse probability treatment weighting to balance differences in baseline characteristics.

RESULTS:

Overall, 486 patients who initiated apalutamide (mean age 70.3 years, 53.5% white, 25.4% Black, 58.1% Medicare-insured) and 601 patients who initiated enzalutamide (mean age 70.5 years, 52.9% white, 25.5% Black, 58.8% Medicare-insured) were included. Duration of continuous treatment use was 9.6 months for apalutamide and 8.6 months for enzalutamide. Despite longer continuous ARPI use among patients treated with apalutamide relative to enzalutamide, the number of inpatient admissions (rate ratio [RR] = 0.58; 95% confidence interval [CI] = 0.37, 0.86; p = 0.012), number of admission days (RR = 0.58; 95% CI = 0.19, 0.70; p = 0.004), as well as all-cause medical costs (mean monthly cost difference = -$1,845; 95% CI = -$52, -$4,908; p = 0.044) were significantly lower in the apalutamide cohort than the enzalutamide cohort during the observation period. Mean monthly all-cause pharmacy costs between the cohorts was not significantly different ($2,121; 95% CI = -2,389, 5,703; p = 0.320).

LIMITATIONS:

This study relied on administrative claims and clinical data, which may contain coding inaccuracies or omissions. While linkages between the data sources are comprehensive, any mislinkages may have led to misclassification and information bias.

CONCLUSION:

The findings of this study suggest that apalutamide may result in better economic outcomes relative to enzalutamide.

01 Nov 2025·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Novel androgen receptor inhibitors in prostate cancer: What do we know so far?

Review

Author: Rifaldi, Francesca ; Sporeni, Silvio ; Secondino, Simona ; Montagna, Benedetta ; Naspro, Richard Lawrence John ; Pedrazzoli, Paolo ; Tortorella, Anna ; Figini, Simone ; Lanzetta, Irene ; Lancia, Andrea ; Chiellino, Silvia

Prostate cancer (PC) is the second most common cancer among males, following lung cancer, more frequently occurring at an advanced age. Even nowadays, early diagnosis represents a challenge and validated screening methods are still missing. To date, multiple therapeutic strategies are available and a tailored approach is possible. The backbone of PC therapy is represented by the inhibition of the androgen signaling pathway, which mediates tumor cells growth. In this current therapeutic scenario, androgen-receptors signaling inhibitors (ARSIs) play a role in improving cancer treatment. This paper provides an overview of the currently available treatment options, focusing on the new drugs (ARSIs), their actual implications and future developments. METHODS: We conducted a research from Pubmed and Embase database regarding the terms 'prostate cancer', 'ARSI', 'androgen receptor inhibitors', ''enzalutamide", "apalutamide", and "Darolutamide". Original full-text articles published in English were reviewed. Based on this research 185 potentially relevant articles were found, limiting our research to the period 2019-2025 of publication. 75 articles were excluded on the basis of abstract, title or the content.

01 Nov 2025·INTERNATIONAL JOURNAL OF PHARMACEUTICS

A machine learning model (Sol_ME) assisted development of a unit-dose lipid formulation for apalutamide: formulation, pharmacokinetics, and pharmacodynamics evaluation

Article

Author: Patel, Mehul ; Dongre, Sanika ; Kishanlal, Sharma Muralidhar ; Patel, Swayamprakash ; Nandpal, Manish ; Shah, Neel ; Kapade, Yash ; Patel, Alkesh ; Patel, Samir

PURPOSE:

The development of a novel lipid-based formulation for apalutamide, a potent androgen receptor inhibitor for non-metastatic castration-resistant prostate cancer (nmCRPC), is explored in this study.

METHOD:

To address its poor solubility and high dose requirement, a single-dose lipid-based soft gelatin capsule delivering 240 mg of apalutamide was developed using machine learning (ML)-assisted excipient selection. The ML model, Sol_ME, predicted cinnamon oil as the optimal solubilizer, enhanced further by vanillin. The optimized formulation showed improved dispersion, stability, and bioavailability.

RESULT:

In pharmacokinetic studies, the test formulation achieved a Cmax of 7860.66 ng/mL at 8.34 h compared to 4850.19 ng/mL at 12.82 h for the standard formulation. AUC0-∞ values were 190,500.75 and 123,879.63 ng·h/mL, respectively, indicating significantly enhanced absorption. Pharmacodynamic assessments confirmed superior androgen suppression and tumor inhibition.

CONCLUSION:

This AI-guided, lipid-based system offers an efficient, patient-friendly alternative for apalutamide administration.

150

News (Medical) associated with Apalutamide

20 Oct 2025

·www.businesswire.com

Kairos Pharma Presents on Phase 2 Trial of ENV-105 in Advanced Prostate Cancer at European Society Medical Oncologists (ESMO) Meeting

LOS ANGELES--(BUSINESS WIRE)--Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, today presents on the positive interim efficacy data from its ongoing Phase 2 clinical trial of ENV-105 (carotuximab) in patients with metastatic castration-resistant prostate cancer (mCRPC) at the annual European Society Medical Oncologists meeting in Berlin, Germany. An interim efficacy analysis from the ongoing trial with ENV-105, a first-in-class CD105 antagonist, is being tested for safety and early efficacy in men with metastatic prostate cancer resistant to standard hormone therapy. Despite progression on prior hormonal therapies, the trial showed clinical benefit when combining ENV-105 with hormone therapy, apalutamide, in 86% of treated patients. All responders remained progression-free for at least four months and half remained progression-free beyond one year. Notably, seven of nine evaluable patients experienced a reduction in PSA levels from baseline. “The positive safety profile and initial clinical benefit we’ve seen through our extensive interim analysis validates the comprehensive mechanism of action studies that preceded this clinical study, demonstrating how ENV-105 restores a patient’s ability to respond to hormone therapy,” said Dr. Neil Bhowmick, CSO of Kairos Pharma. Edwin Posadas, Director of the Experimental Therapeutics Program and the Medical Director of the Center for Uro-Oncology Research Excellence at the Cedars-Sinai Cancer Institute, leads the randomized Phase 2 trial that is currently accruing up to 100 patients at Cedars-Sinai Medical Center, City of Hope Cancer Center, and the Huntsman Cancer Institute. The 13.7 median PFS (progression free survival) achieved by imaging with the ENV-105 and apalutamide combination reported would suggest an improvement over current alternatives of chemotherapy and radioligand therapy, in terms of disease control as well as tolerability. Kairos Pharma seeks to provide a safe and effective therapy with ENV-105 for the over 3 million men with hormone-resistant prostate cancer worldwide. About Kairos Pharma, Ltd. Based in Los Angeles, California, Kairos Pharma Ltd. (NYSE American: KAPA) aims to work at the forefront of oncology therapeutics, utilizing structural biology to overcome drug resistance and immune suppression in cancer. Our lead candidate, ENV105, is an antibody that targets CD105 – a protein identified as a key driver of resistance to various cancer treatments. Elevation of CD105 in response to standard therapy results in resistance and disease relapse. ENV105 aims to reverse drug resistance by targeting CD105 and restore the effectiveness of standard therapies across multiple cancer types. Currently, ENV105 is in a Phase 2 clinical trial for castrate-resistant prostate cancer and a Phase 1 trial for lung cancer aimed at addressing significant unmet medical needs. For more information, visit kairospharma.com. CAUTIONARY STATEMENT CONCERNING FORWARD-LOOKING STATEMENTS This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. You can identify forward-looking statements as those that are not historical in nature, particularly those that use terminology such as “may,” “should,” “expects,” “anticipates,” “contemplates,” “estimates,” “believes,” “plans,” “projected,” “predicts,” “potential” or “hopes” or the negative of these or similar terms. The reader is cautioned not to rely on these forward-looking statements. If underlying assumptions prove inaccurate, or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Kairos Pharma. We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us. Such forward-looking statements relate to future events or our future performance. In evaluating these forward-looking statements, you should consider various factors, including: our expectations regarding the success and/or completion of our Phase 2 clinical trial; our success in completing newly initiated clinical trials, commence new trials, and obtain regulatory approval following the conclusion of such trials; challenges and uncertainties inherent in product research and development; and the uncertainty regarding future commercial success. These and other factors may cause our actual results to differ materially from any forward-looking statement. Forward-looking statements are only predictions. The forward-looking statements discussed in this press release and other statements made from time to time by us or our representatives, may not occur, and actual events and results may differ materially and are subject to risks, uncertainties and assumptions about us, including those described in Kairos Pharma’s Annual Report on Form 10-K, as amended, and our other filings made with the Securities and Exchange Commission. We are not obligated to publicly update or revise any forward-looking statement, and Kairos Pharma is not required to update any forward-looking statement as a result of new information or future events or developments, except as required by U.S. federal securities laws.

Phase 2Clinical Result

14 Oct 2025

·www.fiercepharma.com

J&J chief Joaquin Duato expects to find 'common ground' with Trump administration as industry's MFN talks play out

Johnson & Johnson has been in an "open dialogue" with the Trump administration about the government's policy priorities for the industry, CEO Joaquin Duato said on a Tuesday conference call. With two Trump administration drug pricing deals in the books and more likely on the way, the U.S. policy environment could soon stabilize for many Big Pharma companies. That put Johnson & Johnson in an interesting position this week, as the drugmaker led the vanguard on the industry's third-quarter earnings reporting but has yet to strike a formal pricing accord with the government.Still, comments from J&J’s chief executive suggest that the company is largely aligned with many of President Donald Trump’s policy goals on medicine costs and manufacturing—and that a favorable agreement resembling those struck by Pfizer and AstraZeneca could be on the horizon.“We’ve been talking with this administration with an open dialogue since day one—even before day one,” CEO Joaquin Duato said on a conference call Tuesday, addressing an analyst question about the company’s current outlook on pharmaceutical import tariffs and drug pricing reform in the U.S.“We are always looking, as we have done at Johnson & Johnson, for common ground to build [on] the administration priorities that are similar to ours,” he continued. “Priorities like making sure that American patients have access to innovation in an affordable and timely way; priorities like making sure that foreign entities do not free ride on American innovation; making sure that we are able to maintain the overall leadership that this country has in life sciences; and finally, making sure that we continue to invest in manufacturing in this country to build good middle class jobs.”Duato stressed that J&J is committed to delivering on each of those aims, which echo many of the talking points the administration laid out this summer when it pressed 17 large drugmakers to embrace Trump’s “most favored nation” (MFN) approach to drug pricing and sales.In essence, the framework seeks to align prices of branded drugs in the U.S. to costs in developed countries overseas. The President has also made direct-to-consumer sales channels and tougher negotiating on drug prices in foreign countries key components of the MFN agenda.The strategy has so far yielded deals with Pfizer and AstraZeneca, with administration officials teasing that several more agreements are on the way. By making MFN commitments, Pfizer and AZ have also won timed exemptions from another key facet of Trump’s industry policy: tariffs.Duato said on Tuesday that conversations between J&J and the administration are “ongoing,” noting that he couldn’t share details but that he felt “optimistic that we are going to land in a place which is going to create common ground between the administration and ourselves.” Policy musings aside, J&J’s third-quarter earnings call was more or less business-as-usual for the New Jersey drug giant, save for the news that it plans to spin off its orthopedics business.For the latest three-month earnings period, J&J delivered sales growth of 6.8% to $24 billion. J&J’s innovative medicine engine was firing on all cylinders and delivered overall sales slightly above analyst consensus estimates at nearly $16 billion for the period, Leerink Partners’ David Risinger wrote in a note to clients Tuesday.In particular, 11 of J&J’s novel drugs turned out to have double-digit growth in Q3, the company’s EVP and worldwide chairman of innovative medicine, Jennifer Taubert, said on the Tuesday earnings call. As in previous quarters, Taubert was especially enthusiastic about Tremfya—J&J’s Stelara successor—which grew revenue more than 40% to $1.4 billion from July through September.That roster of double-digit performers—which also includes medicines like Darzalex, Erleada, Spravato and Caryvkti—is expected to be J&J's "growth drivers throughout the rest of the decade," Taubert explained.Taubert also touched on J&J’s latest approval in the drug-releasing system for bladder cancer, Inlezxo, which passed muster with the FDA in early September.J&J’s Inlexzo field team is now “out in full launch mode,” Taubert noted, stressing J&J’s confidence that the bladder cancer product represents a “$5 billion-plus” asset for the company.The drug has already generated excitement among doctors, Taubert said, noting that it was “really designed by urologists for urologists.” With much of the attention on its current crop of branded drugs, J&J plans to focus most of its financial firepower internally, the executives said Tuesday. In particular, they hit back against the idea that J&J is in the market for a large-scale acquisition.“We rely on a thoughtful, long-term approach to growing through any loss of exclusivity, and won’t carelessly deploy capital on speculative transactions out of desperation,” Joe Wolk, J&J’s chief financial officer, said on the call. “Our current portfolio and pipeline have momentum, and with the Stelara loss of exclusivity increasingly in the rear view mirror, we do not need to rely on large transactions to drive our growth.” Wolk’s comments came shortly after reports surfaced that J&J is looking to buy out its immunology partner Protagonist Therapeutics. A report from The Wall Street Journal last week noted that the deal could value Protagonist at well over $4 billion.Meanwhile, given its performance in the quarter, J&J has lifted its revenue projection for the full year. The company now expects to reel in 2025 sales between $93.5 billion and $93.9 billion, up from a previous range of $93.2 billion to $93.6 billion.

Acquisition

14 Oct 2025

·www.businesswire.com

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

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

Drug ApprovalFinancial Statement

100 Deals associated with Apalutamide

External Link

KEGG	Wiki	ATC	Drug Bank
D11040	Apalutamide	L02BB05	DB11901

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Metastatic Prostate Carcinoma	Japan	Janssen Pharmaceutical KK	29 May 2020
Metastatic castration-resistant prostate cancer	United States	Janssen Biotech, Inc.	17 Sep 2019
Hormone-dependent prostate cancer	European Union	Janssen-Cilag International NV	14 Jan 2019
Hormone-dependent prostate cancer	Iceland	Janssen-Cilag International NV	14 Jan 2019
Hormone-dependent prostate cancer	Liechtenstein	Janssen-Cilag International NV	14 Jan 2019
Hormone-dependent prostate cancer	Norway	Janssen-Cilag International NV	14 Jan 2019
Prostatic Cancer	Canada	Janssen Research & Development LLC	27 Jul 2018
Castration-sensitive prostate cancer	Australia	Janssen-Cilag Pty Ltd.	05 Jul 2018
Castration-Resistant Prostatic Cancer	United States	Janssen Biotech, Inc.	14 Feb 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Adenocarcinoma of prostate	Phase 3	Hong Kong	Janssen LP	20 Jul 2020
Recurrent Prostate Carcinoma	Phase 3	Hong Kong	Janssen LP	20 Jul 2020
Non-metastatic prostate cancer	Phase 3	France	Janssen Pharmaceutica NV	09 Jan 2020
Alzheimer Disease	Phase 3	United States	Aragon Pharmaceuticals, Inc.	07 Dec 2015
Alzheimer Disease	Phase 3	United States	Janssen Research & Development LLC	07 Dec 2015
Alzheimer Disease	Phase 3	United States	Xian-Janssen Pharmaceutical Ltd.	07 Dec 2015
Alzheimer Disease	Phase 3	Japan	Aragon Pharmaceuticals, Inc.	07 Dec 2015
Alzheimer Disease	Phase 3	Japan	Janssen Research & Development LLC	07 Dec 2015
Alzheimer Disease	Phase 3	Japan	Xian-Janssen Pharmaceutical Ltd.	07 Dec 2015
Alzheimer Disease	Phase 3	Argentina	Xian-Janssen Pharmaceutical Ltd.	07 Dec 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03098836 (PANTHER, CTgov)	Phase 2	Metastatic castration-resistant prostate cancer	93	ARN-509+Prednisone+Abiraterone Acetate (Caucasian)	rnjhohpghe = fblkxiegca bfhpcbstiz (qbtzfxpenh, lqbcczqira - oufoqivgkj) View more	-	12 Sep 2025
				ARN-509+Prednisone+Abiraterone Acetate (African American)	rnjhohpghe = pttiounycs bfhpcbstiz (qbtzfxpenh, sgwdyvpqrq - symlsjfmhm) View more
NCT04530552 (CTgov)	Phase 2	Localized Prostate Carcinoma \| Adenocarcinoma of prostate	34	apalutamide (Cohort 1)	nkbejfhqzt = mhebiidfwi hcuizwolne (lyifgzdvdv, aiqwbdiala - gqqalslatz) View more	-	29 Aug 2025
				apalutamide (Cohort 2)	nkbejfhqzt = jtzmndijfb hcuizwolne (lyifgzdvdv, svfpvunhxz - yvcmwarmxq) View more
NCT03298087 (CTgov)	Phase 2	Oligometastatic Prostate Carcinoma	28	stereotactic body radiotherapy+apalutamide+Abiraterone+Leuprolide	yyalkdkhwr = oxqlcxbelk pzvnpdufkg (drgtmqwizk, mecxymopwj - imawcnvzzt) View more	-	01 Aug 2025
NCT03412396 (CTgov)	Phase 2	Adenocarcinoma of prostate	45	Apalutamide	fgindfemhc = mjjcjjcxgt aovzibwjzr (slbqymoemg, znmuztnwhx - dplgonfdyb) View more	-	03 Jul 2025
ASCO2025	Not Applicable	Hormone-dependent prostate cancer PSA kinetics	129	Apalutamide plus ADT	fcnfyumhum(vnamegszay) = egwsthszoy zqpmvivqhn (rcydncpwzm ) View more	Positive	30 May 2025
PANTHER phase II study, Abi Race phase II study (ASCO2025)	Phase 2	CYP3A4 \| ACTH	-	Apalutamide + Abiraterone Acetate + Prednisone	shfekbpjfc(fmdtrlnvrb) = vjglozpfna rdyvjrlebf (vgaqprnbyv ) View more	Negative	30 May 2025
				Abiraterone Acetate + Prednisone	shfekbpjfc(fmdtrlnvrb) = zdvfjroora rdyvjrlebf (vgaqprnbyv ) View more
NCT04926181 (CTgov)	Phase 2	Prostate Neuroendocrine Carcinoma \| Small cell carcinoma of prostate	2	Apalutamide+Cetrelimab	mcygclbmfm = pfdabwdpap wzcsofdwfq (ozwlsuemjz, sulbfnjtqp - wqrsepoxpn) View more	-	15 May 2025
NCT04108208 (CTgov)	Phase 4	Castration-Resistant Prostatic Cancer	75	Placebo (Placebo Plus Androgen-deprivation Therapy (ADT))	vbablmlmks(hqrxnfahyj) = anjcqpqynm hljylyvwqh (govxmqkcxn, doxincnnwo - qnyxncrmbu) View more	-	28 Mar 2025
				Apalutamide (Apalutamide 240 mg Plus ADT)	vbablmlmks(hqrxnfahyj) = jufreobuwg hljylyvwqh (govxmqkcxn, xoaobkdjad - cntpsxcmdd) View more
NCT05717660 (PERSIAN, ASCO_GU2025) Manual	Phase 2	Hormone-dependent prostate cancer	174	Apalutamide+ADT (ARM A: Control)	txyldquuhh(mavexeklxj) = qgmcetskui fuqizfpnqf (ikknbntuxn )	Positive	13 Feb 2025
				Apalutamide+ADT+SBRT (ARM B: Treatment)	txyldquuhh(mavexeklxj) = dkzubfnsll fuqizfpnqf (ikknbntuxn )
NCT02489318 (TITAN, ASCO_GU2025) Manual	Phase 3	Castration-sensitive prostate cancer	524	Apalutamide + ADT (With CV/metabolic risk factors at baseline)	aagtdikllt(qxklrsfysw): HR = 0.49 (95% CI, 0.38 - 0.63), P-Value = <0.0001 View more	Positive	13 Feb 2025
				Placebo + ADT (With CV/metabolic risk factors at baseline)

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