Form 8-K

8-K — JOHNSON & JOHNSON

Accession: 0000200406-26-000163

Filed: 2026-07-29

Period: 2026-07-29

CIK: 0000200406

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — jnj-20260729.htm (Primary)

EX-99.1 (exhibit991firefly.htm)

EX-99.2 (exhibit992sail.htm)

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8-K

8-K (Primary)

Filename: jnj-20260729.htm · Sequence: 1

jnj-20260729

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of The

Securities Exchange Act of 1934

Date of report (Date of earliest event reported):

July 29, 2026

Johnson & Johnson

(Exact name of registrant as specified in its charter)

New Jersey

1-3215

22-1024240

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

One Johnson & Johnson Plaza, New Brunswick, New Jersey 08933

(Address of Principal Executive Offices)

(Zip Code)

Registrant's telephone number, including area code:

732-524-0400

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company

☐

If an emerging growth company, indicate 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. ☐

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

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, Par Value $1.00

JNJ

New York Stock Exchange

1.150% Notes Due November 2028

JNJ28

New York Stock Exchange

2.700% Notes Due February 2029

JNJ29B

New York Stock Exchange

3.200% Notes Due June 2032

JNJ32

New York Stock Exchange

3.050% Notes Due February 2033

JNJ33B

New York Stock Exchange

1.650% Notes Due May 2035

JNJ35

New York Stock Exchange

3.350% Notes Due June 2036

JNJ36A

New York Stock Exchange

3.350% Notes Due February 2037

JNJ37B

New York Stock Exchange

3.550% Notes Due June 2044

JNJ44

New York Stock Exchange

3.600% Notes Due February 2045

JNJ45

New York Stock Exchange

3.700% Notes Due February 2055

JNJ55

New York Stock Exchange

Item 7.01 Regulation FD Disclosure

On July 29, 2026, Johnson & Johnson (the “Company”) announced the completion of the acquisition of Firefly Bio, Inc. (“Firefly”) and the entry into strategic agreements and collaboration with Sail Biomedicines (“Sail”). The combination of these two transactions is expected to reduce the Company’s adjusted operational earnings per share (Adjusted Operational EPS) and adjusted earnings per share (Adjusted EPS) by approximately $0.64 in 2026, consisting of approximately $0.46 attributable to the Firefly acquisition and approximately $0.18 attributable to the Sail transaction.

As a result of these transactions, the Company is updating its full year 2026 guidance relative to the guidance previously issued on July 15, 2026, as set forth below:

($ in billions, except EPS)

July 29, 2026

July 15, 2026

Transactions Impact

Adjusted operational sales1,2

Change vs. prior year / midpoint

6.2% - 6.8% / 6.5%

Maintain

Operational sales2 / midpoint

$100.3B - $100.9B / $100.6B

Change vs. prior year / midpoint

6.5% - 7.1% / 6.8%

Estimated reported sales3 / midpoint

$100.8B - $101.4B / $101.1B

Change vs. prior year / midpoint

7.0% - 7.6% / 7.3%

Adjusted pre-tax operating margin4,5

Decrease by ~ 75 bps vs. prior year

Increase by ~ 75 bps vs. prior year

Decrease ~ 150 bps

Adjusted operational EPS (diluted)2,4 / midpoint

$10.86 - $11.01 / $10.94

$11.50 - $11.65 / $11.58

Decrease $0.64

Change vs. prior year / midpoint

0.7% - 2.1% / 1.4%

6.6% - 8.0% / 7.3%

Decrease 5.9%

EPS – Currency impact (dollars / percentage)

$0.10 / 0.9%

Maintain

Adjusted EPS (diluted)3,4 / midpoint

$10.96 - $11.11 / $11.04

$11.60 - $11.75 / $11.68

Decrease $0.64

Change vs. prior year / midpoint

1.6% - 3.0% / 2.3%

7.5% - 8.9% / 8.2%

Decrease 5.9%

1Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures

2Non-GAAP financial measure; excludes the impact of translational currency

3Calculated using Euro Average Rate: July 2026 = $1.15 (illustrative purposes only)

4Non-GAAP measure; excludes intangible amortization expense and special items

5Sales less: COGS, SM&A and R&D expenses

Note: values may have been rounded

The combination of these two transactions is also expected to reduce the Company’s 2027 Adjusted Operational EPS and Adjusted EPS by approximately $1.36, consisting of approximately $0.08 attributable to the Firefly acquisition and approximately $1.28 attributable to the Sail transaction, which assumes Sail’s achievement of certain development milestones and the Company’s option grant, if exercised, under the agreements with Sail.

The Company’s press release announcing the completion of the Firefly acquisition is attached to this Current Report on Form 8-K as Exhibit 99.1. The Company’s press release announcing the strategic agreements and collaboration with Sail is attached to this Current Report on Form 8-K as Exhibit 99.2.

Cautionary Statement Regarding Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements regarding the acquisition of Firefly Bio, Inc. and the strategic agreements and collaboration with Sail Biomedicines and their expected effect on the financial results of Johnson & Johnson. 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 our current expectations and projections. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson’s annual report on Form 10-K for the fiscal year

ended December 28, 2025, 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.

Non-GAAP Financial Measures

This Current Report on Form 8-K includes adjusted operational sales, operational sales, adjusted pre-tax operating margin, adjusted operational EPS, and adjusted EPS, which are non-GAAP financial measures. The Company believes that providing these non-GAAP financial measures enhances the Company’s and investors’ understanding of our financial performance. Non-GAAP financial measures should not be considered a substitute for, or superior to, financial measures determined or calculated in accordance with GAAP. The Company’s definitions of its non-GAAP financial measures may not be comparable to similarly titled measures reported by other companies. The most directly comparable GAAP measures to adjusted operational sales and operational sales is sales. The most directly comparable GAAP measure to adjusted pre-tax operating margin is operating margin. The most directly comparable GAAP measures to adjusted operational EPS and adjusted EPS is earnings per share, or EPS. The Company is not providing reconciliations to these GAAP metrics, however, because Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis as the Company is unable to predict with reasonable certainty the ultimate outcome of adjusted items, such as 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.

Item 9.01 Financial statements and exhibits

(d) Exhibits.

Exhibit No. Description of Exhibit

99.1

Press Release dated July 29, 2026

99.2

Press Release dated July 29, 2026

104

The cover page from this Current Report on Form 8-K, formatted in Inline XBRL.

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 hereunto duly authorized.

Date: July 29, 2026

JOHNSON & JOHNSON

(Registrant)

By:

/s/ Marc Larkins

Marc Larkins

Corporate Secretary

EX-99.1

Filename: exhibit991firefly.htm · Sequence: 2

Document

Exhibit 99.1

Media contact:

J&J Global Media Relations

Media-relations@its.jnj.com

Investor contact:

Jess Margevich

investor-relations@its.jnj.com

For immediate release

Johnson & Johnson Completes Acquisition of Firefly Bio, Inc. to Advance Next-Generation Oncology Innovation

•Broadens capabilities in targeting pan-KRAS and other drivers of hard-to-treat cancers

•Adds novel degrader antibody conjugate platform designed to address key limitations of existing therapies

•Advances leadership in next-generation antibody engineering to accelerate oncology innovation

NEW BRUNSWICK, NJ (July 29, 2026) – Johnson & Johnson (NYSE: JNJ) today announced the successful completion of its acquisition of Firefly Bio, Inc., a biotechnology company advancing its proprietary Firelink™ degrader antibody conjugate (DAC) platform, for $1 billion in cash. The Firelink™ DAC platform expands Johnson & Johnson’s oncology portfolio and advances its ambition to develop targeted therapies for some of the most prevalent and difficult-to-treat solid tumors, including KRAS-driven cancers, where patients continue to face significant unmet need1.

With the close of the transaction, Johnson & Johnson further deepens its capabilities in next-generation antibody engineering and broadens its strategy for tackling complex tumor biology. The Firelink™ DAC platform is designed to deliver highly selective protein degraders directly to cancer cells, enabling targeted activity while preserving healthy tissue—a key limitation of many current treatment approaches.

“The completion of this acquisition marks an important step in advancing new approaches to better address difficult-to-treat solid tumors,” said John Reed, M.D., Ph.D., Executive Vice President, Innovative Medicine, Research & Development, Johnson & Johnson. By bringing together Firefly Bio’s differentiated technology with our deep expertise in oncology and antibody engineering, we are well positioned to accelerate the development of more precise and effective therapies. We are excited to welcome the talented Firefly Bio team to Johnson & Johnson as we continue this work together.”

Johnson & Johnson is at the forefront of oncology therapies

Anchored in decades of oncology leadership, Johnson & Johnson is redefining standards of care and expanding what is possible for people living with cancer. Integrating Firefly Bio’s capabilities further strengthens this commitment, enabling new approaches to address some of the most challenging solid tumors, including those driven by KRAS.

About the agreement

The transaction will be accounted for as an asset acquisition, resulting in an in-process research and development charge of approximately $1 billion in the third quarter of 2026. Johnson & Johnson expects the transaction to dilute adjusted operational earnings per share and adjusted earnings per share by approximately $0.46 in 2026 and approximately $0.08 in 2027. Please refer to the Current Report on Form 8-K furnished to the SEC on the date of this press release for updated full year 2026 guidance.

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 https://www.jnj.com/ or at www.innovativemedicine.jnj.com. Follow us @JNJInnovMed.

Caution Concerning Forward-Looking Statements:

1 https://www.sciencedirect.com/science/article/pii/S1535610826000103#bib19

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the acquisition of Firefly Bio, Inc. 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: the potential that the expected benefits and opportunities of the acquisition may not be realized or may take longer to realize than expected; challenges inherent in product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new products; economic conditions, including currency exchange and interest rate fluctuations; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to applicable laws and regulations, including tax laws and global health care reforms; adverse litigation or government action; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; and trends toward health care cost containment. In addition, there will be risks and uncertainties related to the ability of the Johnson & Johnson family of companies to successfully integrate Firefly Bio, Inc. as well as the ability to ensure successful development and regulatory approval of Firefly Bio, Inc. programs. 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, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

Non-GAAP Financial Measures

This press release includes adjusted operational earnings per share and adjusted earnings per share, which represent non-GAAP financial measures. Johnson & Johnson believes that providing these non-GAAP financial measure enhances the company’s and investors’ understanding of our financial performance. Non-GAAP financial measures should not be considered a substitute for, or superior to, financial measures determined or calculated in accordance with GAAP. The company’s definitions of its non-GAAP financial measures may not be comparable to similarly titled measures reported by other companies. The most directly comparable GAAP measure to adjusted operational earnings per share and adjusted earnings per share is earnings per share, or EPS. The Company is not providing reconciliations to EPS, however, because Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis as the company is unable to predict with reasonable certainty the ultimate outcome of adjusted items, such as 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.

# # #

EX-99.2

Filename: exhibit992sail.htm · Sequence: 3

Document

Exhibit 99.2

Media contact:

J&J Global Media Relations

Media-relations@its.jnj.com

Investor contact:

Jessica Margevich

investor-relations@its.jnj.com

For immediate release

Johnson & Johnson Announces Collaboration with Sail Biomedicines to Advance in vivo CAR-T Programs and Transform Autoimmune Disease Through Immune Reset

•Advances differentiated immunology program with the potential to address significant unmet need in immune-mediated disease

•Novel in vivo CAR-T platform is designed to generate CAR-T therapies directly within the body, enabling scalable treatments with durable, disease-modifying, and curative potential

•Strengthens Johnson & Johnson's leadership in immunology and CAR-T innovation

•Grants Johnson & Johnson an exclusive option to acquire Sail

NEW BRUNSWICK, NJ (July 29, 2026) – Johnson & Johnson1 (NYSE: JNJ) today announced strategic agreements and collaboration with Sail Biomedicines (Sail), a biotechnology company developing in vivo CAR-T therapies for immune-mediated diseases. Johnson & Johnson will collaborate with Sail to advance its lead immune-mediated disease program and broader platform technology, with incentives to expand the application of Sail's in vivo CAR-T platform across additional therapeutic targets over time. Johnson & Johnson2 will also make an equity investment in Sail. Additionally, Johnson & Johnson has been granted an exclusive option to acquire Sail for $2.58 billion.

In vivo CAR-T therapies represent one of the most promising frontiers in medicine, with the potential to deliver transformative therapies across a range of cancer and immune-mediated diseases. Unlike traditional cell therapies, Sail’s lead program and platform are designed to reprogram a patient’s immune cells directly within the body, with the goal of resetting the immune system and delivering durable disease control. Through this collaboration, Johnson & Johnson and Sail will combine their expertise to advance innovative in vivo CAR-T therapies that have the potential to improve patient outcomes and ultimately deliver curative treatment approaches for people living with complex diseases.

“People living with serious immune-mediated diseases continue to need treatments that can deliver deeper, more durable disease control,” said John Reed, Executive Vice President, Innovative Medicine Research & Development, Johnson & Johnson. “Sail’s innovative platform represents an exciting new approach that seeks to harness the power of CAR-T therapy in a simpler, more scalable way. By working together with Sail, we aim to accelerate the development of innovative therapies that have the potential to fundamentally transform how immune-mediated diseases are treated.”

Building on its leadership in immunology and established expertise in CAR-T therapy within oncology, Johnson & Johnson continues to invest in emerging technologies with the potential to reshape disease treatment and transform patient outcomes. The agreement with Sail expands the Company’s capabilities in in vivo CAR-T, strengthens its position at the forefront of immune system reprogramming and immune reset, and creates opportunities to advance future programs across a range of complex diseases.

Under the terms of the agreements, Johnson & Johnson would make total initial payments of $785 million3, including a $465 million equity investment, and additional contingent payments of $140 million if certain development milestones are achieved. Subject to Johnson & Johnson's decision to exercise the option, Johnson & Johnson would make an additional payment of $2.58 billion. Assuming exercise of the option, Johnson & Johnson expects the agreements to dilute adjusted operational earnings per share and adjusted earnings per share by approximately $0.18 in 2026 and approximately $1.28 in 2027. Please refer to the Current Report on Form 8-K furnished to the SEC on the date of this press release for updated full year 2026 guidance.

1 Collaboration agreement between Sail and Janssen Biotech, Inc., a Johnson & Johnson company.

2 Equity investment made by Johnson & Johnson Innovation – JJDC Inc., Johnson & Johnson’s corporate venture capital arm.

3 Payments to be allocated amongst Sail and Sail shareholders based on the terms of the agreements.

The transactions are subject to applicable regulatory approvals and/or other conditions.

About Johnson & Johnson

Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com. Follow us @JNJInnovMed.

Caution Concerning Forward-Looking Statements:

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 related to the investment in and collaboration with Sail Biomedicines. 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: the satisfaction of closing conditions for the equity investment; the possibility that the investment will not be completed in the expected timeframe or at all; the potential that the expected benefits of the investment, if fully completed, may not be realized or may take longer to realize than expected; the potential that the expected benefits and opportunities related to the collaboration may not be realized or may take longer to realize than expected; challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. 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, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

Non-GAAP Financial Measures

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Name of the City or Town

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Code for the postal or zip code

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Name of the state or province.

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A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.

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Indicate if registrant meets the emerging growth company criteria.

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Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.

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Two-character EDGAR code representing the state or country of incorporation.

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The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.

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The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.

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Local phone number for entity.

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

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Trading symbol of an instrument as listed on an exchange.

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

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