Johnson & Johnson

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 6.2% - 6.8% / 6.5% Maintain Change vs. prior year / midpoint 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% 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: July 2026 = $1.15 (illustrative purposes only) 4 Non-GAAP measure; excludes intangible amortization expense and special items 5 Sales 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.