Johnson & Johnson 10-Q 2025-03-30

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

for the quarterly period ended March 30, 2025

or

Commission file number 1-3215

Johnson & Johnson

(Exact name of registrant as specified in its charter)

One Johnson & Johnson Plaza

New Brunswick, New Jersey 08933

(Address of principal executive offices)

Registrant’s telephone number, including area code (732) 524-0400

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☑ Yes ☐ No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☑ Yes ☐ No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicated by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☑ No

SECURITIES REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

On April 18, 2025, 2,406,073,279 shares of Common Stock, $1.00 par value, were outstanding.

JOHNSON & JOHNSON AND SUBSIDIARIES

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Cautionary note regarding forward-looking statements

This Quarterly Report on Form 10-Q and Johnson & Johnson’s other publicly available documents contain “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Management and representatives of Johnson & Johnson and its subsidiaries (the Company) also may from time to time make forward-looking statements. Forward-looking statements do not relate strictly to historical or current facts and reflect management’s assumptions, views, plans, objectives and projections about the future. Forward-looking statements may be identified by the use of words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and other words of similar meaning in conjunction with, among other things: discussions of future operations, expected operating results, financial performance; impact of planned acquisitions and dispositions; impact and timing of restructuring initiatives including associated cost savings and other benefits; the Company’s strategy for growth; product development activities; regulatory approvals; market position and expenditures.

Because forward-looking statements are based on current beliefs, expectations and assumptions regarding future events, they are subject to uncertainties, risks and changes that are difficult to predict and many of which are outside of the Company’s control. Investors should realize that if underlying assumptions prove inaccurate, or known or unknown risks or uncertainties materialize, the Company’s actual results and financial condition could vary materially from expectations and projections expressed or implied in its forward-looking statements. Investors are therefore cautioned not to rely on these forward-looking statements. Risks and uncertainties include, but are not limited to:

Risks related to product development, market success and competition

• Challenges and uncertainties inherent in innovation and development of new and improved products and technologies on which the Company’s continued growth and success depend, including uncertainty of clinical outcomes, additional analysis of existing clinical data, obtaining regulatory approvals, health plan coverage and customer access, and initial and continued commercial success;

• Challenges to the Company’s ability to secure and maintain adequate patent and other intellectual property rights for new and existing products and technologies in the United States and other important markets;

• The impact of patent expirations, typically followed by the introduction of competing generic, biosimilar or other products and resulting revenue and market share losses;

• Increasingly aggressive and frequent challenges to the Company’s patents by competitors and others seeking to launch competing generic, biosimilar or other products and increased receptivity of courts, the United States Patent and Trademark Office and other decision makers to such challenges, potentially resulting in loss of market exclusivity and rapid decline in sales for the relevant product sooner than expected;

• Competition in research and development of new and improved products, processes and technologies, which can result in product and process obsolescence;

• Competition to reach agreement with third parties for collaboration, licensing, development and marketing agreements for products and technologies;

• Competition based on cost-effectiveness, product performance, technological advances and patents attained by competitors; and

• Allegations that the Company’s products infringe the patents and other intellectual property rights of third parties, which could adversely affect the Company’s ability to sell the products in question and require the payment of money damages and future royalties.

Risks related to product liability, litigation and regulatory activity

• Product efficacy or safety concerns, whether or not based on scientific evidence, potentially resulting in product withdrawals, recalls, regulatory action on the part of the United States Food and Drug Administration (U.S. FDA) (or international counterparts), declining sales, reputational damage, increased litigation expense and share price impact;

• The impact, including declining sales and reputational damage, of significant litigation or government action adverse to the Company, including product liability claims and allegations related to pharmaceutical marketing practices and contracting strategies;

• The impact of an adverse judgment or settlement and the adequacy of reserves related to legal proceedings, including patent litigation, product liability, personal injury claims, securities class actions, government investigations, employment and other legal proceedings;

• Increased scrutiny of the healthcare industry by government agencies and state attorneys general resulting in investigations and prosecutions, which carry the risk of significant civil and criminal penalties, including, but not limited to, debarment from government business;

• Failure to meet compliance obligations in compliance agreements with governments or government agencies, which could result in significant sanctions;

• Potential changes to applicable laws and regulations affecting United States and international operations, including relating to: approval of new products; licensing and patent rights; sales and promotion of healthcare products; access to, and reimbursement and pricing for, healthcare products and services; environmental protection; and sourcing of raw materials;

• Compliance with local regulations and laws that may restrict the Company’s ability to manufacture or sell its products in relevant markets, including requirements to comply with medical device reporting regulations and other requirements such as the European Union’s Medical Devices Regulation;

• Changes in domestic and international tax laws and regulations, increasing audit scrutiny by tax authorities around the world may cause exposures to additional tax liabilities potentially in excess of existing reserves; and

• The issuance of new or revised accounting standards by the Financial Accounting Standards Board and regulations by the Securities and Exchange Commission.

Risks related to the Company’s strategic initiatives and healthcare market trends

• Pricing pressures resulting from trends toward healthcare cost containment, including the continued consolidation among healthcare providers and other market participants, trends toward managed care, the shift toward governments increasingly becoming the primary payors of healthcare expenses, significant new entrants to the healthcare markets seeking to reduce costs and government pressure on companies to voluntarily reduce costs and price increases;

• Restricted spending patterns of individual, institutional and governmental purchasers of healthcare products and services due to economic hardship and budgetary constraints;

• Challenges to the Company’s ability to realize its strategy for growth including through externally sourced innovations, such as development collaborations, strategic acquisitions, licensing and marketing agreements, and the potential heightened costs of any such external arrangements due to competitive pressures;

• The potential that the expected strategic benefits and opportunities from any planned or completed acquisition or divestiture by the Company may not be realized or may take longer to realize than expected; and

• The potential that the expected benefits and opportunities related to past and ongoing restructuring actions may not be realized or may take longer to realize than expected.

Risks related to economic conditions, financial markets and operating internationally

• The risks associated with global operations on the Company and its customers and suppliers, including foreign governments in countries in which the Company operates;

• The impact of inflation and fluctuations in interest rates and currency exchange rates and the potential effect of such fluctuations on revenues, expenses and resulting margins;

• Potential changes in export/import and trade laws, regulations and policies of the United States and other countries, including any increased trade restrictions or tariffs and potential drug reimportation legislation, and the impact of such changes on raw material prices, supply chains market volatility and the pace of product development;

• The impact on international operations from financial instability in international economies, sovereign risk, possible imposition of governmental controls and restrictive economic policies, and unstable international governments and legal systems;

• The impact of global public health crises and pandemics;

• Changes to global climate, extreme weather and natural disasters that could affect demand for the Company’s products and services, cause disruptions in manufacturing and distribution networks, alter the availability of goods and services within the supply chain, and affect the overall design and integrity of the Company’s products and operations;

• The impact of global or economic changes or events, including global tensions and war; and

• The impact of armed conflicts and terrorist attacks in the United States and other parts of the world, including social and economic disruptions and instability of financial and other markets.

Risks related to supply chain and operations

• Difficulties and delays in manufacturing, internally, through third-party providers or otherwise within the supply chain, that may lead to voluntary or involuntary business interruptions or shutdowns, product shortages, withdrawals or suspensions of products from the market, and potential regulatory action;

• Interruptions and breaches of the Company’s information technology systems or those of the Company’s vendors, which could result in reputational, competitive, operational or other business harm as well as financial costs and regulatory action;

• Reliance on global supply chains and production and distribution processes that are complex and subject to increasing regulatory requirements that may adversely affect supply, sourcing and pricing of materials used in the Company’s products; and

• The potential that the expected benefits and opportunities related to restructuring actions may not be realized or may take longer to realize than expected, including due to any required approvals from applicable regulatory authorities.

Investors also should carefully read the Risk Factors described in Item 1A of the Company's Annual Report on Form 10-K for the fiscal year ended December 29, 2024, for a description of certain risks that could, among other things, cause the Company’s actual results to differ materially from those expressed in its forward-looking statements. Investors should understand that it is not possible to predict or identify all such factors and should not consider the risks described above to be a complete statement of all potential risks and uncertainties. The Company does not undertake to publicly update any forward-looking statement that may be made from time to time, whether as a result of new information or future events or developments.

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Part I — Financial information

Johnson & Johnson and subsidiaries consolidated balance sheets

(Unaudited; Dollars in Millions Except Share and Per Share Data)

See Notes to Consolidated Financial Statements

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Johnson & Johnson and subsidiaries consolidated statements of earnings

(Unaudited; Dollars & Shares in Millions Except Per Share Amounts)

See Notes to Consolidated Financial Statements

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Results of operations

Sales to customers

Analysis of consolidated sales

For the fiscal first quarter of 2025, worldwide sales were $21.9 billion, a total increase of 2.4%, which included operational growth of 4.2% and a negative currency impact of 1.8% as compared to 2024 fiscal first quarter sales of $21.4 billion. In the fiscal first quarter of 2025, the net impact of acquisitions and divestitures on worldwide operational sales growth was a positive 0.9%. In the fiscal first quarter of 2025, the impact of the Stelara sales decline, due to biosimilar competition, on the worldwide operational sales was approximately negative 4.7%.

Sales by U.S. companies were $12.3 billion in the fiscal first quarter of 2025, which represented an increase of 5.9% as compared to the prior year. In the fiscal first quarter of 2025, the net impact of acquisitions and divestitures on the U.S. operational sales growth was a positive 1.5%. In the fiscal first quarter of 2025, the impact of the Stelara sales decline, due to biosimilar competition on the U.S. operational sales was approximately negative 4.9%. Sales by international companies were $9.6 billion, a total decrease of 1.8%, which included operational growth of 2.1% offset by a negative currency impact of 3.9%. In the fiscal first quarter of 2025, the net impact of acquisitions and divestitures on international operational sales growth was a positive 0.2%. In the fiscal first quarter of 2025, the impact of the Stelara sales decline, due to biosimilar competition, on the international operational sales was approximately negative 4.6%.

In the fiscal first quarter of 2025, sales by companies in Europe experienced a sales decline of 1.0%, which included operational growth of 2.2% offset by a negative currency impact of 3.2%. Sales by companies in the Western Hemisphere, excluding the U.S., experienced a sales decline of 2.3%, which included operational growth of 9.2% offset by a negative currency impact of 11.5%. Sales by companies in the Asia-Pacific, Africa region experienced a sales decline of 2.8%, which included an operational decline of 0.6% and a negative currency impact of 2.2%.

Q1 2025 Sales by Geographic Region (in billions)

Q1 2025 Sales by Segment (in billions)

Note: values may have been rounded

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Analysis of sales by business segments

Innovative Medicine

Innovative Medicine segment sales in the fiscal first quarter of 2025 were $13.9 billion, an increase of 2.3% as compared to the same period a year ago, including an operational increase of 4.2% and a negative currency impact of 1.9%. U.S. Innovative Medicine sales increased 6.3% as compared to the same period a year ago. International Innovative Medicine sales decreased by 2.9%, including an operational increase of 1.5% offset by a negative currency impact of 4.4%. In the fiscal first quarter of 2025, the net impact of acquisitions and divestitures on the worldwide Innovative Medicine segment operational sales growth was a negative 0.2%. In the fiscal first quarter of 2025, the impact of the Stelara sales decline, due to biosimilar competition, was an approximate negative 8.1% on the worldwide, U.S. and international Innovative Medicine segment operational sales.

Major Innovative Medicine therapeutic area sales — Fiscal First Quarter Ended

*percentage greater than 100% or not meaningful

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(1) Previously in Other Oncology

(2) Opsynvi was previously in Other Pulmonary Hypertension

(3) Includes the Covid-19 Vaccine in 2024

Oncology products achieved operational sales growth of 20.4% as compared to the same period a year ago. Strong sales of DARZALEX (daratumumab) were driven by continued share gains and market growth. Growth of ERLEADA (apalutamide) was due to continued share gains and market growth partially offset by the impact of Medicare Part D redesign (Part D). Increased sales of CARVYKTI (ciltacabtagene autoleucel) were driven by continued share gains and capacity expansion. Additionally, sales from the ongoing launches of TECVAYLI (teclistamab-cqyv), TALVEY (talquetamab-tgvs) and RYBREVANT (amivantamab)/LAZCLUZE (lazertinib) contributed to the growth. Growth was partially offset by ZYTIGA (abiraterone acetate) due to loss of exclusivity and IMBRUVICA (ibrutinib) declines due to competitive pressures and the impact of Part D.

Immunology products experienced an operational decline of 10.9% as compared to the same period a year ago primarily due to the decline of STELARA (ustekinumab) sales driven by the impact of biosimilar competition and Part D. The growth of TREMFYA (guselkumab) was due to share gains and market growth partially offset by the impact of Part D. The SIMPONI/SIMPONI ARIA sales increase was primarily driven by the Merck, Sharp & Dohme return of rights in Europe in the fiscal fourth quarter of 2024. The REMICADE (infliximab) sales increase was due to a one-time favorable patient mix, market growth, and the Merck, Sharp & Dohme return of rights in Europe, partially offset biosimilar competition.

Sales of STELARA in the United States were approximately $6.7 billion in fiscal 2024. Third parties have filed abbreviated Biologics License Applications with the FDA seeking approval to market biosimilar versions of STELARA. The Company has settled certain litigation under the Biosimilar Price Competition and Innovation Act of 2009. According to patent settlement and license agreements, the Company expects continued launches of biosimilar versions of STELARA in Europe and the United States in 2025 which will impact the Company’s sales of STELARA.

Neuroscience products experienced an operational decline of 7.0% as compared to the same period a year ago. The decline was driven by INVEGA SUSTENNA / XEPLION / INVEGA TRINZA / TREVICTA primarily due to the impact of Part D and Other Neuroscience primarily due to RISPERDAL/RISPERDAL CONSTA and the PONVORY divestiture. The decline was partially offset by the growth of SPRAVATO (esketamine) driven by the ongoing launch and increased physician and patient demand.

Pulmonary Hypertension products experienced an operational decline of 1.2% as compared to the same period a year ago. Sales growth of OPSUMIT (macitentan)/ OPSYNVI (macitentan/tadalafil) were driven by share gains and market growth partially offset by the impact of Part D redesign. The sales decline of UPTRAVI (selexipag) was driven by the impact of Part D partially offset by market growth.

Infectious disease products achieved operational sales growth of 0.1% as compared to the same period a year ago primarily driven by EDURANT/rilpivirine partially offset by declines across the portfolio including COVID-19 vaccine revenue in Other Infectious Diseases.

Cardiovascular / Metabolism / Other products achieved operational growth of 23.4% as compared to the same period a year ago. The growth of XARELTO (rivaroxaban) sales was primarily driven by one-time favorable patient mix and the impact of Part D.

The Company maintains a policy that no end customer will be permitted direct delivery of product to a location other than the billing location. This policy impacts contract pharmacy transactions involving non-grantee 340B covered entities for most of the Company’s drugs, subject to multiple exceptions. Both grantee and non-grantee covered entities can maintain certain contract pharmacy arrangements under policy exceptions. The Company has been and will continue to offer 340B discounts to covered entities on all of its covered outpatient drugs, and it believes its policy will improve its ability to identify inappropriate duplicate discounts and diversion prohibited by the 340B statute. The 340B Drug Pricing Program is a U.S. federal government program requiring drug manufacturers to provide significant discounts on covered outpatient drugs to covered entities.

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MedTech

MedTech segment sales in the fiscal first quarter of 2025 were $8.0 billion, an increase of 2.5% as compared to the same period a year ago, which included operational growth of 4.1% and a negative currency impact of 1.6%. U.S. MedTech sales increased 5.1%. International MedTech sales decreased by 0.2%, including operational growth of 3.0% offset by a negative currency impact of 3.2%. In the fiscal first quarter of 2025, the net impact of acquisitions and divestitures on the MedTech segment operational sales growth was a positive 2.8%, primarily related to the Shockwave acquisition.

Major MedTech franchise sales — Fiscal First Quarter Ended

(1) Acquired on May 31, 2024

*Percentage greater than 100% or not meaningful

The Surgery franchise achieved operational sales growth of 1.1% as compared to the prior year fiscal first quarter. The operational growth in Advanced Surgery was primarily due to the strength of the portfolio and recovery from U.S. supply challenges in Biosurgery as well as commercial execution in Biosurgery and Endocutters and strategic price actions in Endocutters. The growth was partially offset by competitive pressures in Energy and Endocutters as well as the negative impact of China volume-based procurement. The operational growth in General Surgery was primarily driven by technology penetration and upgrades within the differentiated Wound Closure portfolio and tender timing outside the U.S. The growth was partially offset by the impact from divestitures.

The Orthopaedics franchise experienced an operational sales decline of 3.1% as compared to the prior year fiscal first quarter. All platforms were impacted by one-time events: the lapping of the prior year one-time revenue recognition timing change related to certain products in the U.S., fewer selling days, and revenue disruption from the previously announced Orthopaedics restructuring. The operational decline in Hips reflects the aforementioned one-time events partially offset by the continued strength of the portfolio. The operational decline in Knees was driven by the aforementioned one-time events and tender timing outside the U.S. partially offset by procedure growth, strength of the ATTUNE portfolio and pull through related to the VELYS Robotic assisted solution. The operational growth in Trauma was primarily driven by the continued adoption of recently launched products, procedure growth, and commercial execution, partially offset by the aforementioned one-time events. The operational sales decline in Spine, Sports & Other reflects the aforementioned one-time events, competitive pressures, price pressures in the U.S. Early Interventional segment, and China volume-based procurement partially offset by growth in Shoulders.

The Cardiovascular franchise, which includes sales from Shockwave Medical (Shockwave) acquired on May 31, 2024, achieved operational sales growth of 17.7% as compared to the prior year fiscal first quarter. Abiomed sales growth was driven by the continued strong adoption of Impella 5.5 and Impella CP. Electrophysiology sales declined due to competitive pressures in Pulsed

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Field Ablation catheters and lapping of prior year inventory build in Asia. The decline was mostly offset by global procedure growth, new products and commercial execution.

The Vision franchise achieved operational sales growth of 3.7% as compared to the prior year fiscal first quarter. The Contact Lenses/Other operational growth was driven by price actions and continued strong performance in the ACUVUE OASYS 1-Day family of products (including recent launches). The Surgical operational growth was primarily driven by the continued strength of recent innovations and commercial execution partially offset by competitive pressures in the U.S.

Analysis of consolidated earnings before provision for taxes on income

Consolidated earnings before provision for taxes on income for the fiscal first quarter of 2025 was $13.6 billion representing 62.3% of sales as compared to $3.7 billion in the fiscal first quarter of 2024, representing 17.4% of sales. The fiscal first quarter of 2025 includes the reversal of approximately $7.0 billion, a significant portion of the previously accrued talc reserve. The fiscal first quarter of 2024 includes charges for talc matters of approximately $2.7 billion.

Cost of products sold

(Dollars in billions. Percentages in chart are as a percent to total sales)

Q1 2025 versus Q1 2024

Cost of products sold increased as a percent to sales primarily driven by:

• Unfavorable currency and product mix in the Innovative Medicine business

• The fair value inventory step-up and amortization related to Shockwave

The intangible asset amortization expense included in cost of products sold for both the fiscal first quarters of 2025 and 2024 was $1.1 billion.

Selling, marketing and administrative expenses

(Dollars in billions. Percentages in chart are as a percent to total sales)

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Q1 2025 versus Q1 2024

Selling, Marketing and Administrative Expenses decreased as a percent to sales primarily driven by:

• Planned leverage and phasing of investments in the Innovative Medicine business.

Research and development expense

Research and development expense by segment of business was as follows:

Q1 2025 versus Q1 2024

Research and Development decreased as a percent to sales driven by:

• Reduced spending and phasing of investments in the Innovative Medicine business

partially offset by

• Investments associated with Shockwave and V-Wave in the MedTech business

Interest (income) expense

Interest (income) expense in the fiscal first quarter of 2025 was net income of $128 million as compared to net income of $209 million in the fiscal first quarter of 2024. Interest income in the fiscal first quarter of 2025 decreased slightly as compared to the prior year driven by lower interest rates earned on cash balances. Interest expense was slightly higher due to a higher average debt balance at higher interest rates. The balance of cash, cash equivalents and current marketable securities was $38.8 billion at the end of the fiscal first quarter of 2025 as compared to $26.2 billion at the end of the fiscal first quarter of 2024. The Company’s debt position was $52.3 billion as of March 30, 2025, as compared to $33.6 billion the same period a year ago.

Other (income) expense, net*

Q1 2025 versus Q1 2024

Other (income) expense, net for the fiscal first quarter of 2025 reflected an increase in income of $9.7 billion as compared to the prior year primarily due to the following:

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(1)The fiscal first quarter of 2025 includes the reversal of approximately $7.0 billion, a significant portion of the previously accrued talc reserve. The fiscal first quarter of 2024 includes charges for talc matters. For additional details related to talc refer to Note 11 to the Consolidated Financial Statements.

*Other (income) expense, net is the account where the Company records gains and losses related to the sale and write-down of certain investments in equity securities held by Johnson & Johnson Innovation - JJDC, Inc. (JJDC), changes in the fair value of securities, gains and losses on divestitures, gains and losses on sale of assets, certain transactional currency gains and losses, acquisition-related costs, litigation accruals and settlements, investment (income)/loss related to employee benefit plans, as well as royalty income.

Segment income before tax

Income (loss) before tax by segment of business for the fiscal first quarters were as follows:

(1)Amounts not allocated to segments include interest (income) expense, certain litigation expenses and general corporate (income) expense. The fiscal first quarter of 2025 includes the reversal of approximately $7.0 billion, a significant portion of the previously accrued talc reserve. The fiscal first quarter of 2024 includes charges for talc matters of $2.7 billion. For additional details related to talc refer to Note 11 to the Consolidated Financial Statements.

Innovative Medicine segment

The Innovative Medicine segment income before tax as a percent of sales in the fiscal first quarter of 2025 was 37.6% versus 36.6% for the same period a year ago. The increase in the income before tax as a percent of sales for the fiscal first quarter of 2025 as compared to the prior year was primarily driven by the following:

• Lower restructuring related costs and amortization expense of $0.6 billion in 2025 versus $0.8 billion in 2024

• Planned leverage and phasing of investments in Selling, Marketing and Administrative Expenses

• Reduced spending and phasing of investments in Research & Development

partially offset by

• Unfavorable currency in Cost of products sold

• Product mix and Part D

MedTech segment

The MedTech segment income before tax as a percent of sales in the fiscal first quarter of 2025 was 17.7% versus 19.4% for the same period a year ago. The decrease in the income before tax as a percent of sales for the fiscal first quarter of 2025 as compared to the prior year was primarily driven by the following:

• The fair value inventory step-up and amortization related to Shockwave of $0.1 billion in 2025

• Increased investments in Research & Development associated with Shockwave and V-Wave

Restructuring

In the fiscal year 2023, the Company initiated a restructuring program of its Orthopaedics franchise within its MedTech segment to streamline operations by exiting certain markets, product lines and distribution network arrangements. The pre-tax restructuring expense was $55 million in the fiscal first quarter of 2025, of which $17 million was recorded in Restructuring, $8 million in Cost of products sold and $30 million in Other (Income)/Expense on the Consolidated Statement of Earnings primarily for costs related to asset impairments and market and product exits. The pre-tax restructuring expense was $27 million in the fiscal first quarter of 2024, of which $20 million was recorded in Restructuring and $7 million was recorded in Cost of products sold on the Consolidated Statement of Earnings. Total project costs of approximately $0.5 billion have been recorded since the restructuring was announced.

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In the fiscal year 2023, the Company completed a prioritization of its research and development (R&D) investment within the Innovative Medicine segment to focus on the most promising medicines with the greatest benefit to patients. The pre-tax restructuring charge of approximately $0.1 billion in the fiscal first quarter of 2024 included the termination of partnered and non-partnered program costs and asset impairments. The program was completed in the fiscal fourth quarter of 2024.

For further details related to the restructuring refer to Note 12 to the Consolidated Financial Statements.

Provision for taxes on income

The worldwide effective income tax rate for the fiscal three months was 19.3% in 2025 and 12.4% in 2024.

On December 15, 2022, the European Union (EU) Member States formally adopted the EU’s Pillar Two Directive, which generally provides for a minimum effective tax rate of 15%, as established by the Organization for Economic Co-operation and Development (OECD) Pillar Two Framework that was supported by over 130 countries worldwide. Several EU and non-EU countries have enacted Pillar Two legislation with an initial effective date of January 1, 2024, with other aspects of the law effective in 2025 or later. While countries continue to enact new provisions or issue new regulations this could have an impact to the Company’s effective tax rate.

For further details related to the fiscal 2025 provision for taxes refer to Note 5 to the Consolidated Financial Statements.

Liquidity and capital resources

Acquisitions (net of cash acquired)

Proceeds from the disposal of assets/businesses, net

Dividends to shareholders

Cash flows

Cash and cash equivalents were $38.5 billion at the end of the fiscal first quarter of 2025 as compared with $24.1 billion at the end of fiscal year 2024. The primary sources and uses of cash that contributed to the $14.4 billion increase were:

In addition, the Company had $0.3 billion in marketable securities at the end of the fiscal first quarter of 2025 and $0.4 billion at the end of fiscal year 2024.

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Cash flow from operations of $4.2 billion was the result of:

Cash flow used by investing activities of $0.3 billion was primarily from:

Cash flow from financing activities of $10.4 billion was primarily from:

The Company has access to substantial sources of funds at numerous banks worldwide and has the ability to issue up to $20 billion in Commercial Paper. Furthermore, in June 2024, the Company secured a new 364-day Credit Facility of $10 billion (expiration on June 25, 2025) which may be used for general corporate purposes including to support our commercial paper borrowings. Interest charged on borrowings under the credit line agreement is based on either Secured Overnight Financing Rate (SOFR) Reference Rate or other applicable market rate as allowed plus applicable margins. Commitment fees under the agreement are not material.

As of March 30, 2025, the Company had cash, cash equivalents and marketable securities of approximately $38.8 billion and had approximately $52.3 billion of notes payable and long-term debt for a net debt position of $13.5 billion as compared to the prior year fiscal first quarter net debt position of $7.4 billion. In the fiscal first quarter of 2025, the Company issued senior unsecured notes for approximately $9.2 billion. For additional details on borrowings, see Note 4 to the Consolidated Financial Statements. The net proceeds from this offering were used to fund the Intra-Cellular Therapies, Inc. acquisition for approximately $14.6 billion which closed subsequent to the quarter on April 2, 2025, and for general corporate purposes. The Company anticipates that operating cash flows, the ability to raise funds from external sources, borrowing capacity from existing committed credit facilities and access to the commercial paper markets will continue to provide sufficient resources to fund operating needs, including the Company’s remaining balance of approximately $4.2 billion related to talc matters and the remaining approximately $1.5 billion to settle opioid litigation (See Note 11 to the Consolidated Financial Statements for additional details). In addition, the Company monitors the global capital markets on an ongoing basis and from time to time may raise capital when market conditions are favorable.

Subsequent to March 30, 2025, the Company paid approximately $3.0 billion to the U.S. Treasury, including $2.5 billion related to the final installment due on foreign undistributed earnings as part of the TCJA charge (see Note 1 to the Consolidated Financial Statements in the Company’s Annual Report on Form 10-K for the fiscal year ended December 29, 2024) and $0.5 billion primarily

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related to the normal estimated payment for the fiscal first quarter of 2025. Additionally, the Company has paid $0.6 billion in income related taxes net of refunds in foreign jurisdictions in the first three months of fiscal 2025.

Dividends

On January 2, 2025, the Board of Directors declared a regular cash dividend of $1.24 per share, payable on March 4, 2025, to shareholders of record as of February 18, 2025.

On April 15, 2025, the Board of Directors declared a regular cash dividend of $1.30 per share, payable on June 10, 2025, to shareholders of record as of May 27, 2025. The Company expects to continue the practice of paying regular quarterly cash dividends.

Other information

New accounting pronouncements

Refer to Note 1 to the Consolidated Financial Statements for new accounting pronouncements.

Economic and market factors

In July 2023, Janssen Pharmaceuticals, Inc. (Janssen) filed litigation against the U.S. Department of Health and Human Services as well as the Centers for Medicare and Medicaid Services challenging the constitutionality of the IRA's Medicare Drug Price Negotiation Program. The litigation requests a declaration that the IRA violates Janssen’s rights under the First Amendment and the Fifth Amendment to the Constitution and therefore that Janssen is not subject to the IRA’s mandatory pricing scheme. The impact of the IRA on our business and the broader pharmaceutical industry remains uncertain, as litigation filed by Janssen and other pharmaceutical companies remains ongoing and while CMS has publicly announced the maximum fair price for each of the selected drugs, implementation of the program is still in progress. In April 2024, Janssen appealed the district court’s denial of its summary judgment motion to the Third Circuit.

Russia-Ukraine war

Although the long-term implications of Russia’s invasion of Ukraine are difficult to predict at this time, the financial impact of the conflict in the fiscal first quarter of 2025, including accounts receivable or inventory reserves, was not material. As of the fiscal three months ending March 30, 2025, and the fiscal year ending December 29, 2024, the business of the Company’s Russian subsidiaries represented less than 1% of the Company’s consolidated assets and represented approximately 1% of revenues. The Company does not maintain Ukrainian subsidiaries.

In March of 2022, the Company took steps to suspend all advertising, enrollment in clinical trials, and any additional investment in Russia. The Company continues to supply products relied upon by patients for healthcare purposes.

Conflict in the Middle East

Although the long-term implications of the conflict in the Middle East are difficult to predict at this time, the financial impact of the conflict in the fiscal first quarter of 2025, including accounts receivable or inventory reserves, was not material. As of the fiscal three months ending March 30, 2025, and the fiscal year ending December 29, 2024, the business of the Company’s Israel subsidiaries represented less than 1% of both Company’s consolidated assets and revenues.

Other Macroeconomic Considerations

The Company operates in certain countries where the economic conditions continue to present significant challenges. The Company continues to monitor these situations and take appropriate actions. Inflation rates and currency exchange rates continue to have an effect on worldwide economies and, consequently, on the way the Company operates. The Company has accounted for operations in Venezuela, Argentina, Turkey and Egypt (beginning in the fiscal fourth quarter of 2024) as highly inflationary, as the prior three-year cumulative inflation rate surpassed 100%. In the face of increasing costs, the Company strives to maintain its profit margins through cost reduction programs, productivity improvements and periodic price increases.

Governments around the world consider various proposals to make changes to tax laws, which may include increasing or decreasing existing statutory tax rates. In connection with various government initiatives, companies are required to disclose more information to tax authorities on operations around the world, which may lead to greater audit scrutiny of profits earned in other countries.

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A change in statutory tax rate in any country would result in the revaluation of the Company’s deferred tax assets and liabilities related to that particular jurisdiction in the period in which the new tax law is enacted. This change would result in an expense or benefit recorded to the Company’s Consolidated Statement of Earnings. The Company closely monitors these proposals as they arise in the countries where it operates. Changes to the statutory tax rate may occur at any time, and any related expense or benefit recorded may be material to the fiscal quarter and year in which the law change is enacted.

The Company may be further impacted by the imposition of tariffs, trade protection measures or other policies adopted by any jurisdiction that favor domestic companies and technologies over foreign competitors.

The Company faces various worldwide health care changes that may continue to result in pricing pressures that include health care cost containment and government legislation relating to sales, promotions and reimbursement of health care products.

Changes in the behavior and spending patterns of purchasers of healthcare products and services, including delaying medical procedures, rationing prescription medications, reducing the frequency of physician visits and foregoing healthcare insurance coverage, may continue to impact the Company’s businesses.

The Company faces regular intellectual property challenges from third parties, including generic and biosimilar manufacturers, seeking to manufacture and market generic and biosimilar versions of key pharmaceutical products prior to the expiration of the applicable patents. These challengers file Abbreviated New Drug Applications or abbreviated Biologics License Applications with the FDA or otherwise challenged the coverage and/or validity of the Company’s patents. In the event the Company is not successful in defending the patent claims challenged in the resulting lawsuits, generic or biosimilar versions of the products at issue may be introduced to the market, resulting in the potential for substantial market share and revenue losses for those products, and which may result in a non-cash impairment charge in any associated intangible asset. There is also risk that one or more competitors could launch a generic or biosimilar version of the product at issue following regulatory approval even though one or more valid patents are in place.

There has been no material change in the Company’s assessment of its sensitivity to market risk since its presentation set forth in Item 7A, “Quantitative and Qualitative Disclosures About Market Risk,” in its Annual Report on Form 10-K for the fiscal year ended December 29, 2024.

Disclosure controls and procedures. At the end of the period covered by this report, the Company evaluated the effectiveness of the design and operation of its disclosure controls and procedures. The Company’s disclosure controls and procedures are designed to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Securities Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Securities Exchange Act is accumulated and communicated to the Company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate, to allow timely decisions regarding required disclosure. Joaquin Duato, Chief Executive Officer; Chairman, Executive Committee and Joseph J. Wolk, Executive Vice President, Chief Financial Officer, reviewed and participated in this evaluation. Based on this evaluation, Messrs. Duato and Wolk concluded that, as of the end of the period covered by this report, the Company’s disclosure controls and procedures were effective.

Internal control. During the period covered by this report, there were no changes in the Company’s internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting. The Company continues to monitor and assess the effectiveness of the design and operation of its disclosure controls and procedures.

The Company is implementing a multi-year, enterprise-wide initiative to integrate, simplify and standardize processes and systems for the human resources, information technology, procurement, supply chain and finance functions. These are enhancements to support the growth of the Company’s financial shared service capabilities and standardize financial systems. This initiative is not in response to any identified deficiency or weakness in the Company’s internal control over financial reporting. In response to this initiative, the Company has and will continue to align and streamline the design and operation of its financial control environment.

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Part II — Other information

Item 1 — Legal proceedings

The information called for by this item is incorporated herein by reference to Note 11 included in Part I, Item 1, Financial Statements (unaudited) — Notes to Consolidated Financial Statements.

Item 2 — Unregistered sales of equity securities and use of proceeds

(c) Purchases of Equity Securities by the Issuer and Affiliated Purchasers.

The following table provides information with respect to Common Stock purchases by the Company during the fiscal first quarter of 2025. Common stock purchases on the open market are made as part of a systematic plan to meet the needs of the Company's compensation programs. The repurchases below also include the stock-for-stock option exercises that settled in the fiscal first quarter.

(1)During the fiscal first quarter of 2025, the Company repurchased an aggregate of 13,379,900 shares of Johnson & Johnson Common Stock in open-market transactions, all of which were purchased as part of a systematic plan to meet the needs of the Company’s compensation programs.

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Securities trading plans of Directors and Executive Officers. During the fiscal first quarter of 2025, none of our directors or officers (as defined in Rule 16a-1(f) of the Exchange Act) informed us of the adoption or termination of a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” each as defined in Item 408 of Regulation S-K.

Exhibit 31.1 Certification of Chief Executive Officer under Rule 13a-14(a) of the Securities Exchange Act pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 — Filed with this document.

Exhibit 31.2 Certification of Chief Financial Officer under Rule 13a-14(a) of the Securities Exchange Act pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 — Filed with this document.

Exhibit 32.1 Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 — Furnished with this document.

Exhibit 32.2 Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 — Furnished with this document.

Exhibit 101:

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Signatures

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.