JOHNSON & JOHNSON (JNJ) · Material Event (8-K) SEC Filing

EX-99.1 2 exhibit991firefly.htm EX-99.1 Document Exhibit 99.1 Media contact J J Global Media RelationsMedia-relations its.jnj.com Investor contact Jess Margevichinvestor-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 innovationNEW 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 therapiesAnchored 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 JohnsonAt 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 MeasuresThis 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 3 exhibit992sail.htm EX-99.2 Document Exhibit 99.2 Media contact J J Global Media RelationsMedia-relations its.jnj.com Investor contact Jessica Margevichinvestor-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 SailNEW 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 JohnsonAt 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 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 MeasuresThis 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.# # #