Rilpivirine Hydrochloride

Pictured: 3D illustration of the CRISPR-Cas9 system editing a stretch of DNA/iStock, Meletios Verras Excision BioTherapeutics’ attempt to use a CRISPR-based gene editing therapy to cure HIV has failed an early-stage study, according to several media reports on Friday. Results from the Phase I trial of five patients showed that Excision’s CRISPR therapeutic did not strongly suppress the HIV virus. Three patients who were taken off of antiretroviral therapy soon developed viral rebound and needed to resume conventional treatments, according to reporting by STAT News. Still, Excision’s approach did show signs of promise. One patient was able to keep the virus at bay for 16 weeks after stopping antiretroviral treatment before rebounding. Typically, HIV levels resurge after around four weeks. The experimental CRISPR treatment also appears to have lowered the number of infected cells in this patient, according to STAT. In response to the disappointing outcome, CEO Daniel Dornbusch told STAT that Excision is “encouraged” by the safety data in the Phase I study, which suggests that “in-vivo CRISPR can be done in a safe way in humans.” The company will use these findings to work on a new gene editing candidate that it can apply to other chronic viral infections, such as herpes and hepatitis B. According to its website, Excision’s lead candidate is EBT-101, a CRISPR-based gene editor that works by cutting out the HIV pro-viral DNA from all infected cells. The candidate is delivered via an AAV9 vector and uses two guide RNAs that can home in on three target sites in the HIV genome, minimizing the likelihood of viral escape. The company is positioning EBT-101 as a potentially curative treatment for chronic HIV and is “rapidly advancing toward clinical trials.” In October 2023, Excision released safety data from its first-in-human Phase I/II study of EBT-101, showing that there were no serious adverse events or dose-limiting toxicities in all three patients that had been dosed with the gene editor at the time. The study found four mild toxicities that could be potentially related to EBT-101, though all were resolved without intervention. The early data also showed that EBT-101 was present at detectable levels in the blood four weeks after treatment. In addition to targeting HIV, Excision is also leveraging its proprietary CRISPR-based gene-editing platform against herpes 1 and 2, for which it is advancing EBT-104, and hepatitis B, for which it is developing EBT-107. Several biotech companies have responded to the HIV crisis, including industry powerhouses Gilead and GSK. Gilead owns the oral antiretroviral pill Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), while GSK and partner ViiV Healthcare market the oral pill Tivicay (dolutegravir) and long-acting injectable Cabenuva (cabotegravir/rilpivirine). While these virus-suppressive treatments are effective, a true cure remains elusive and the field continues to face several substantial challenges. In March 2024, the World Health Organization warned of a growing virus resistance against Tivicay. Meanwhile, gene therapies which have strong curative potential still pose potential safety concerns, particularly unintended edits and off-target effects. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

2024 First-Quarter reported sales growth of 2.3% to $21.4 Billion with operational growth of 3.9%* and adjusted operational growth of 4.0%* Adjusted operational growth excluding COVID-19 Vaccine of 7.7%* 2024 First-Quarter Earnings per share (EPS) increased to $2.20 and adjusted EPS increased to $2.71 or 12.4%* Company increasing the midpoint for Full-Year 2024 operational sales5 and adjusted operational EPS guidance CORRECTION...by Johnson & Johnson NEW BRUNSWICK, N.J.--(BUSINESS WIRE)-- In the section titled "Full-Year 2024 Guidance", in the table, row titled "Operational Sales2,5/ Mid-point", the numbers for the April 2024 column should read: $88.7B – $89.1B / $88.9B (instead of: $88.7B – $89.1B / $88.0B). The updated release reads: JOHNSON & JOHNSON REPORTS Q1 2024 RESULTS Johnson & Johnson (NYSE: JNJ) today announced results for first-quarter 2024. “Johnson & Johnson’s solid first quarter performance reflects our sharpened focus and the progress in our portfolio and pipeline,” said Joaquin Duato, Chairman and Chief Executive Officer. “Our impact across the full spectrum of healthcare is unique in our industry, and the milestones achieved this quarter reinforce our position as an innovation powerhouse.” Unless otherwise noted, the financial results and earnings guidance included below reflect the continuing operations of Johnson & Johnson. Overall Financial Results Q1 ($ in Millions, except EPS) 2024 2023 % Change Reported Sales $21,383 $20,894 2.3% Net Earnings/(Loss) $5,354 ($491) EPS (Diluted/Basic)6 $2.20 ($0.19) Q1 Non-GAAP* ($ in Millions, except EPS) 2024 2023 % Change Operational Sales1,2 3.9% Adjusted Operational Sales1,3 4.0% Adjusted Operational Sales ex. COVID-19 Vaccine1,3 7.7% Adjusted Net Earnings1,4 $6,580 $6,340 3.8% Adjusted EPS (Diluted)1,4 $2.71 $2.41 12.4% 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency 4 Excludes intangible amortization expense and special items 5 Excludes COVID-19 Vaccine 6 Basic shares are used to calculate loss per share in the first quarter of 2023 as use of diluted shares when in a loss position would be anti-dilutive Note: Values may have been rounded Regional Sales Results Q1 % Change ($ in Millions) 2024 2023 Reported Operational1,2 Currency Adjusted Operational1,3 U.S. $11,620 $10,782 7.8% 7.8 - 7.9 International 9,763 10,112 (3.4) (0.3) (3.1) (0.3) Worldwide $21,383 $20,894 2.3% 3.9 (1.6) 4.0 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency Note: Values may have been rounded Segment Sales Results Q1 % Change ($ in Millions) 2024 2023 Reported Operational1,2 Currency Adjusted Operational1,3 Innovative Medicine $13,562 $13,413 1.1% 2.5 (1.4) 2.5 MedTech 7,821 7,481 4.5 6.3 (1.8) 6.5 Worldwide $21,383 $20,894 2.3% 3.9 (1.6) 4.0 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency Values may have been rounded First Quarter 2024 Segment Commentary: Operational sales* reflected below excludes the impact of translational currency. Adjusted operational sales* reflected below excludes the net impact of acquisitions and divestitures and translational currency. Innovative Medicine Innovative Medicine worldwide operational sales, excluding the COVID-19 Vaccine, grew 8.3%*. Growth was driven by DARZALEX (daratumumab), ERLEADA (apalutamide), CARVYKTI (ciltacabtagene autoleucel), TECVAYLI (teclistamab-cqyv) and Other Oncology in Oncology, UPTRAVI (selexipag) and OPSUMIT (macitentan) in Pulmonary Hypertension, TREMFYA (guselkumab) in Immunology, and SPRAVATO (esketamine) in Neuroscience. Including the COVID-19 Vaccine, Innovative Medicine worldwide operational sales grew 2.5%*. MedTech MedTech worldwide operational sales grew 6.3%* driven primarily by electrophysiology products and Abiomed in Cardiovascular, previously referred to as Interventional Solutions, and wound closure products in General Surgery. Notable New Announcements in the Quarter: The information contained in this section should be read together with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at , or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases and information available in the Investor Relations section of the company’s website at News Releases, as well as Innovative Medicine News Center, MedTech News & Events, , and Regulatory CARVYKTI is the First and Only BCMA-Targeted Treatment Approved by the U.S. FDA for Patients with Relapsed or Refractory Multiple Myeloma Who Have Received At Least One Prior Line of Therapy1 Press Release Johnson & Johnson’s nipocalimab granted U.S. FDA Fast Track designation to reduce the risk of fetal neonatal alloimmune thrombocytopenia (FNAIT) in alloimmunized pregnant adults Press Release Biosense Webster Submits Application to U.S. FDA Seeking Approval of the VARIPULSE Platform for the Treatment of Paroxysmal Atrial Fibrillation Press Release U.S. FDA Approves OPSYNVI (macitentan and tadalafil) as the First and Only Once-Daily Single-Tablet Combination Therapy for Patients with Pulmonary Arterial Hypertension (PAH) Press Release U.S. FDA Oncologic Drugs Advisory Committee recommends CARVYKTI (ciltacabtagene autoleucel) for the earlier treatment of patients with relapsed or refractory multiple myeloma Press Release Johnson & Johnson submits supplemental Biologics License Application to U.S. FDA seeking approval of TREMFYA (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis Press Release Johnson & Johnson submits application to the European Medicines Agency for DARZALEX (daratumumab)-based quadruplet therapy for the treatment of patients with transplant-eligible, newly diagnosed multiple myeloma Press Release RYBREVANT (amivantamab-vmjw) in Combination With Chemotherapy Is the First FDA Approved Therapy for First-line Treatment of Patients With Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations Press Release Janssen Receives Positive CHMP Opinion for CARVYKTI (ciltacabtagene autoleucel; cilta-cel) for Treatment in Earlier Lines of Relapsed and Refractory Multiple Myeloma Press Release TECVAYLI (teclistamab-cqyv) biweekly dosing approved by the U.S. FDA for the treatment of patients with relapsed or refractory multiple myeloma Press Release Johnson & Johnson’s nipocalimab granted U.S. FDA Breakthrough Therapy Designation for the treatment of individuals at high risk for severe hemolytic disease of the fetus and newborn (HDFN) Press Release Johnson & Johnson submits supplemental Biologics License Application to U.S. FDA seeking approval of DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) based regimen for the treatment of patients with transplant-eligible, newly diagnosed multiple myeloma Press Release Data Release Unique molecular properties of nipocalimab enabling differentiated potential in treating generalized myasthenia gravis to be presented at American Academy of Neurology’s 2024 Annual Meeting1 Press Release Johnson & Johnson to Showcase its Broad Scientific Leadership and Latest Innovations to Combat Cardiovascular Disease at ACC.241 Press Release RYBREVANT (amivantamab-vmjw) data at ELCC advance Johnson & Johnson’s ambition to transform the standard of care for patients with EGFR-mutated non-small cell lung cancer Press Release New data shows JNJ-2113, the first and only investigational targeted oral peptide, maintained skin clearance in moderate-to-severe plaque psoriasis through one year Press Release Investigational targeted oral peptide JNJ-2113 demonstrated positive results in moderate-to-severe plaque psoriasis in Phase 2b study published in New England Journal of Medicine Press Release Johnson & Johnson reports positive topline results for Nipocalimab from a Phase 3 pivotal study in generalized myasthenia gravis (gMG) and a Phase 2 study in Sjögren’s Disease (SjD) Press Release Johnson & Johnson Highlights Ambition to Transform the Treatment of Prostate Cancer and Bladder Cancer through Data Presentations at ASCO GU Press Release Product Launch Biosense Webster Announces CE Mark approval in Europe for VARIPULSE Pulsed Field Ablation (PFA) Platform Press Release Other Johnson & Johnson to Acquire Shockwave Medical1 Press Release Johnson & Johnson Completes Acquisition of Ambrx Press Release 1 Subsequent to the quarter Full-Year 2024 Guidance: Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses, and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson's results computed in accordance with GAAP. ($ in Billions, except EPS) April 2024 January 2024 Adjusted Operational Sales1,2,5 Change vs. Prior Year / Mid-point 5.5% – 6.0% / 5.8% 5.0% – 6.0% / 5.5% Operational Sales2,5/ Mid-point Change vs. Prior Year / Mid-point $88.7B – $89.1B / $88.9B 5.5% – 6.0% / 5.8% $88.2B – $89.0B / $88.6B 5.0% – 6.0% / 5.5% Estimated Reported Sales3,5/ Mid-point Change vs. Prior Year / Mid-point $88.0B – $88.4B / $88.2B 4.7% – 5.2% / 5.0% $87.8B – $88.6B / $88.2B 4.5% – 5.5% / 5.0% Adjusted Operational EPS (Diluted)2,4/ Mid-point Change vs. Prior Year / Mid-point $10.60 – $10.75 / $10.68 6.9% – 8.4% / 7.7% $10.55 – $10.75 / $10.65 6.4% – 8.4% / 7.4% Adjusted EPS (Diluted)3,4 / Mid-point Change vs. Prior Year / Mid-point $10.57 – $10.72 / $10.65 6.6% – 8.1% / 7.4% $10.55 – $10.75 / $10.65 6.4% – 8.4% / 7.4% 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: April 2024 = $1.08 and January 2024 = $1.09 (Illustrative purposes only) 4 Non-GAAP financial measure; excludes intangible amortization expense and special items 5 Excludes COVID-19 Vaccine Note: Percentages may have been rounded Other modeling considerations will be provided on the webcast. Webcast Information: Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investor Relations section of the company's website at events-and-presentations. About Johnson & Johnson: At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at . Non-GAAP Financial Measures: * “Operational sales growth” excluding the impact of translational currency, “adjusted operational sales growth” excluding the net impact of acquisitions and divestitures and translational currency, as well as “adjusted net earnings”, “adjusted diluted earnings per share” and “adjusted operational diluted earnings per share” excluding after-tax intangible amortization expense and special items, are non-GAAP financial measures and should not be considered replacements for, and should be read together with, the most comparable GAAP financial measures. Except for guidance measures, reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in the accompanying financial schedules of the earnings release and the Investor Relations section of the company's website at quarterly results. Copies of the financial schedules accompanying this earnings release are available on the company’s website at quarterly results. These schedules include supplementary sales data, a condensed consolidated statement of earnings, reconciliations of non-GAAP financial measures, and sales of key products/franchises. Additional information on Johnson & Johnson, including adjusted income before tax by segment, an Innovative Medicine pipeline of selected compounds in late stage development and a copy of today’s earnings call presentation can also be found in the Investor Relations section of the company's website at quarterly results. Note to Investors Concerning Forward-Looking Statements: This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things: future operating and financial performance, product development, and market position and business strategy. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: economic factors, such as interest rate and currency exchange rate fluctuations; competition, including technological advances, new products and patents attained by competitors; challenges inherent in new product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new and existing products; challenges to patents; the impact of patent expirations; the ability of the Company to successfully execute strategic plans, including restructuring plans; the impact of business combinations and divestitures; manufacturing difficulties or delays, internally or within the supply chain; product efficacy or safety concerns resulting in product recalls or regulatory action; significant adverse litigation or government action, including related to product liability claims; changes to applicable laws and regulations, including tax laws and global health care reforms; trends toward health care cost containment; changes in behavior and spending patterns of purchasers of health care products and services; financial instability of international economies and legal systems and sovereign risk; increased scrutiny of the health care industry by government agencies; the Company’s ability to realize the anticipated benefits from the separation of Kenvue Inc; and Kenvue’s ability to succeed as a standalone publicly traded company. A further list and descriptions 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 31, 2023, 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 , 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. Johnson & Johnson and Subsidiaries Supplementary Sales Data (Unaudited; Dollars in Millions) FIRST QUARTER Percent Change 2024 2023 Total Operations Currency Sales to customers by segment of business Innovative Medicine (1) U.S. 7,612 7,023 8.4 8.4 - International 5,950 6,390 (6.9 ) (4.0 ) (2.9 ) 13,562 13,413 1.1 2.5 (1.4 ) Innovative Medicine excluding COVID-19 Vaccine (1) U.S. 7,612 7,023 8.4 8.4 - International 5,925 5,643 5.0 8.3 (3.3 ) 13,537 12,666 6.9 8.3 (1.4 ) MedTech U.S. 4,008 3,759 6.6 6.6 - International 3,813 3,722 2.4 6.1 (3.7 ) 7,821 7,481 4.5 6.3 (1.8 ) U.S. 11,620 10,782 7.8 7.8 - International 9,763 10,112 (3.4 ) (0.3 ) (3.1 ) Worldwide 21,383 20,894 2.3 3.9 (1.6 ) U.S. 11,620 10,782 7.8 7.8 - International 9,738 9,365 4.0 7.4 (3.4 ) Worldwide excluding COVID-19 Vaccine (1) $ 21,358 20,147 6.0 % 7.6 (1.6 ) Note: Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely. (1) Refer to supplemental sales information schedules Johnson & Johnson and Subsidiaries Supplementary Sales Data (Unaudited; Dollars in Millions) FIRST QUARTER Percent Change 2024 2023 Total Operations Currency Sales to customers by geographic area U.S. $ 11,620 10,782 7.8 % 7.8 - Europe 5,163 5,590 (7.6 ) (7.7 ) 0.1 Western Hemisphere excluding U.S. 1,194 1,076 11.0 21.3 (10.3 ) Asia-Pacific, Africa 3,406 3,446 (1.1 ) 5.0 (6.1 ) International 9,763 10,112 (3.4 ) (0.3 ) (3.1 ) Worldwide $ 21,383 20,894 2.3 % 3.9 (1.6 ) Johnson & Johnson and Subsidiaries Supplementary Sales Data (Unaudited; Dollars in Millions) FIRST QUARTER Percent Change 2024 2023 Total Operations Currency Sales to customers by geographic area (ex. COVID-19 Vaccine) U.S.* $ 11,620 10,782 7.8 % 7.8 - Europe(1) 5,138 4,843 6.1 6.0 0.1 Western Hemisphere excluding U.S.* 1,194 1,076 11.0 21.3 (10.3 ) Asia-Pacific, Africa* 3,406 3,446 (1.1 ) 5.0 (6.1 ) International 9,738 9,365 4.0 7.4 (3.4 ) Worldwide $ 21,358 20,147 6.0 % 7.6 (1.6 ) Note: Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely. (1) Refer to supplemental sales information schedules *No COVID-19 Vaccine sales Johnson & Johnson and Subsidiaries Condensed Consolidated Statement of Earnings (Unaudited; in Millions Except Per Share Figures) FIRST QUARTER 2024 2023 Percent Percent Percent Increase Amount to Sales Amount to Sales (Decrease) Sales to customers $ 21,383 100.0 $ 20,894 100.0 2.3 Cost of products sold 6,511 30.4 6,687 32.0 (2.6 ) Gross Profit 14,872 69.6 14,207 68.0 4.7 Selling, marketing and administrative expenses 5,257 24.6 4,906 23.5 7.2 Research and development expense 3,542 16.6 3,455 16.6 2.5 In-process research and development impairments - - 49 0.2 Interest (income) expense, net (209 ) (1.0 ) 14 0.1 Other (income) expense, net (322 ) (1.5 ) 6,940 33.2 Restructuring 164 0.8 130 0.6 Earnings/(loss) before provision for taxes on income 6,440 30.1 (1,287 ) (6.2 ) Provision for/(Benefit from) taxes on income 1,086 5.1 (796 ) (3.9 ) Net earnings/(loss) from Continuing Operations $ 5,354 25.0 $ (491 ) (2.3 ) Net earnings from Discontinued Operations, net of tax - 423 Net earnings/(loss) $ 5,354 $ (68 ) Net earnings (loss) per share (Diluted/Basic) from Continuing Operations $ 2.20 $ (0.19 ) Net earnings per share (Diluted) from Discontinued Operations $ - $ 0.16 Average shares outstanding (Diluted/Basic) 2,430.1 2,605.5 * Effective tax rate from Continuing Operations 16.9 % 61.8 % Adjusted earnings from Continuing Operations before provision for taxes and net earnings (1) Earnings before provision for taxes on income from Continuing Operations $ 7,877 36.8 $ 7,536 36.1 4.5 Net earnings from Continuing Operations $ 6,580 30.8 $ 6,340 30.3 3.8 Net earnings per share (Diluted) from Continuing Operations $ 2.71 $ 2.41 12.4 Average shares outstanding (Diluted) 2,430.1 2,634.3 Effective tax rate from Continuing Operations 16.5 % 15.9 % *Basic shares are used to calculate loss per share in the first quarter of 2023 as use of diluted shares when in a loss position would be anti-dilutive (1) See Reconciliation of Non-GAAP Financial Measures. Johnson & Johnson and Subsidiaries Reconciliation of Non-GAAP Financial Measures First Quarter (Dollars in Millions Except Per Share Data) 2024 2023 Net Earnings/(loss) from Continuing Operations, after tax- as reported $5,354 ($491 ) Pre-tax Adjustments Litigation related - 6,900 Intangible Asset Amortization expense 1,078 1,122 COVID-19 Vaccine related costs 1 9 444 Restructuring related 2 171 130 Medical Device Regulation 3 51 64 Acquisition, integration and divestiture related 148 42 (Gains)/losses on securities (20 ) 72 IPR&D impairments - 49 Tax Adjustments Tax impact on special item adjustments 4 (229 ) (1,980 ) Tax legislation and other tax related 18 (12 ) Adjusted Net Earnings from Continuing Operations, after tax $6,580 $6,340 Average shares outstanding (Diluted) 2,430.1 2,634.3 Adjusted net earnings per share from Continuing Operations (Diluted) $2.71 $2.41 Operational adjusted net earnings per share from Continuing Operations (Diluted) $2.72 Notes: 1 COVID-19 Vaccine related costs include remaining commitments and obligations, including external manufacturing network exit costs and required clinical trial expenses, associated with the Company's completion of its COVID-19 vaccine contractual commitments. 2 In fiscal 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. This resulted in the exit of certain programs within therapeutic areas. The R&D program exits are primarily in infectious diseases and vaccines including the discontinuation of its respiratory syncytial virus (RSV) adult vaccine program, hepatitis and HIV development. The restructuring expenses of $144 million in the fiscal first quarter of 2024 and $130 million in the fiscal first quarter of 2023 include the termination of partnered and non-partnered program costs and asset impairments. In fiscal 2023, the company initiated a restructuring program of its Orthopaedics franchise within the MedTech segment to streamline operations by exiting certain markets, product lines and distribution network arrangements. The restructuring expenses of $27 million in the fiscal first quarter of 2024 primarily includes costs related to market and product exits. 3 European Medical Device Regulation (MDR) costs represent one-time compliance costs for the Company’s previously registered products. MDR is a replacement of the existing European Medical Devices Directive regulatory framework, and manufacturers of currently marketed medical devices were required to comply with EU MDR beginning in May 2021. The Company considers the adoption of EU MDR to be a significant one-time regulatory change and is not indicative of on-going operations. The Company has excluded only external third-party regulatory and consulting costs from its MedTech operating segments' measures of profit and loss used for making operating decisions and assessing performance which will be completed during 2024. 4 The tax impact related to special item adjustments reflects the current and deferred income taxes associated with the above pre-tax special items in arriving at adjusted earnings. Johnson & Johnson and Subsidiaries Reconciliation of Non-GAAP Financial Measure Adjusted Operational Sales Growth FIRST QUARTER 2024 ACTUAL vs. 2023 ACTUAL Segments Innovative Medicine MedTech Total WW As Reported 1.1% 4.5% 2.3% U.S. 8.4% 6.6% 7.8% International (6.9)% 2.4% (3.4)% WW Currency (1.4) (1.8) (1.6) U.S. - - - International (2.9) (3.7) (3.1) WW Operational 2.5% 6.3% 3.9% U.S. 8.4% 6.6% 7.8% International (4.0)% 6.1% (0.3)% All Other Acquisitions and Divestitures (A&D) 0.0 0.2 0.1 U.S. 0.0 0.2 0.1 International 0.0 0.1 0.0 WW Adjusted Operational Ex A&D 2.5% 6.5% 4.0% U.S. 8.4% 6.8% 7.9% International (4.0)% 6.2% (0.3)% COVID-19 Vaccine 5.8 3.7 U.S. 0.0 0.0 International 12.3 7.7 WW Adjusted Operational Ex A&D & COVID-19 Vaccine 8.3% 6.5% 7.7% U.S. 8.4% 6.8% 7.9% International 8.3% 6.2% 7.4% Note: Percentages are based on actual, non-rounded figures and may not sum REPORTED SALES vs. PRIOR PERIOD ($MM) FIRST QUARTER % Change INNOVATIVE MEDICINE SEGMENT (2) 2024 2023 Reported Operational (1) Currency IMMUNOLOGY US $ 2,453 2,448 0.2% 0.2% - Intl 1,794 1,664 7.9% 11.0% -3.1% WW 4,247 4,112 3.3% 4.6% -1.3% REMICADE US 266 276 -3.9% -3.9% - US Exports (3) 27 41 -32.7% -32.7% - Intl 141 170 -17.2% -14.2% -3.0% WW 434 487 -10.9% -9.9% -1.0% SIMPONI / SIMPONI ARIA US 254 271 -6.2% -6.2% - Intl 299 266 12.4% 20.0% -7.6% WW 554 537 3.0% 6.8% -3.8% STELARA US 1,396 1,451 -3.8% -3.8% - Intl 1,055 993 6.2% 8.2% -2.0% WW 2,451 2,444 0.3% 1.1% -0.8% TREMFYA US 509 406 25.4% 25.4% - Intl 299 234 27.9% 31.5% -3.6% WW 808 640 26.3% 27.6% -1.3% OTHER IMMUNOLOGY US 0 3 * * - Intl 0 0 - - - WW 0 3 * * - INFECTIOUS DISEASES US 324 392 -17.4% -17.4% - Intl 497 1,193 -58.4% -58.5% 0.1% WW 821 1,586 -48.3% -48.3% 0.0% COVID-19 VACCINE US 0 0 - - - Intl 25 747 -96.6% -96.7% 0.1% WW 25 747 -96.6% -96.7% 0.1% EDURANT / rilpivirine US 8 9 -10.9% -10.9% - Intl 315 271 16.6% 15.7% 0.9% WW 323 280 15.7% 14.8% 0.9% PREZISTA / PREZCOBIX / REZOLSTA / SYMTUZA US 314 378 -16.9% -16.9% - Intl 104 99 5.5% 5.5% 0.0% WW 418 477 -12.3% -12.3% 0.0% OTHER INFECTIOUS DISEASES US 2 5 -68.8% -68.8% - Intl 52 77 -32.8% -30.6% -2.2% WW 53 82 -35.1% -33.1% -2.0% REPORTED SALES vs. PRIOR PERIOD ($MM) FIRST QUARTER % Change 2024 2023 Reported Operational (1) Currency NEUROSCIENCE US 1,054 978 7.8% 7.8% - Intl 749 826 -9.3% -4.4% -4.9% WW 1,803 1,804 0.0% 2.2% -2.2% CONCERTA / Methylphenidate US 41 70 -41.2% -41.2% - Intl 136 136 -0.1% 4.5% -4.6% WW 177 206 -14.1% -11.1% -3.0% INVEGA SUSTENNA / XEPLION / INVEGA TRINZA / TREVICTA US 765 713 7.2% 7.2% - Intl 292 331 -11.8% -8.7% -3.1% WW 1,056 1,044 1.2% 2.2% -1.0% SPRAVATO US 191 111 71.5% 71.5% - Intl 34 20 76.1% 74.8% 1.3% WW 225 131 72.2% 72.0% 0.2% OTHER NEUROSCIENCE US 58 84 -31.1% -31.1% - Intl 287 339 -15.5% -8.4% -7.1% WW 345 423 -18.5% -12.9% -5.6% ONCOLOGY US 2,383 1,889 26.2% 26.2% - Intl 2,430 2,223 9.3% 12.6% -3.3% WW 4,814 4,112 17.1% 18.8% -1.7% CARVYKTI US 140 70 99.8% 99.8% - Intl 16 2 * * * WW 157 72 * * * DARZALEX US 1,464 1,191 22.9% 22.9% - Intl 1,228 1,072 14.5% 19.0% -4.5% WW 2,692 2,264 18.9% 21.0% -2.1% ERLEADA US 285 249 14.1% 14.1% - Intl 404 293 38.0% 40.6% -2.6% WW 689 542 27.0% 28.4% -1.4% IMBRUVICA US 265 270 -1.5% -1.5% - Intl 518 557 -7.0% -5.6% -1.4% WW 784 827 -5.2% -4.3% -0.9% TECVAYLI(4) US 101 57 76.7% 76.7% - Intl 33 6 * * * WW 133 63 * * * ZYTIGA / abiraterone acetate US 9 16 -41.3% -41.3% - Intl 172 229 -24.8% -20.7% -4.1% WW 181 245 -25.9% -22.1% -3.8% OTHER ONCOLOGY(4) US 119 35 * * - Intl 60 64 -6.1% -5.6% -0.5% WW 178 99 80.2% 80.5% -0.3% REPORTED SALES vs. PRIOR PERIOD ($MM) FIRST QUARTER % Change 2024 2023 Reported Operational (1) Currency PULMONARY HYPERTENSION US 766 600 27.5% 27.5% - Intl 283 272 4.1% 10.9% -6.8% WW 1,049 872 20.2% 22.4% -2.2% OPSUMIT US 356 273 30.4% 30.4% - Intl 169 167 0.8% 4.6% -3.8% WW 524 440 19.1% 20.6% -1.5% UPTRAVI US 392 304 29.0% 29.0% - Intl 76 58 30.7% 38.6% -7.9% WW 468 362 29.2% 30.5% -1.3% OTHER PULMONARY HYPERTENSION US 18 23 -24.6% -24.6% - Intl 39 47 -16.9% -1.0% -15.9% WW 56 70 -19.5% -8.9% -10.6% CARDIOVASCULAR / METABOLISM / OTHER US 631 715 -11.7% -11.7% - Intl 197 212 -7.0% -6.8% -0.2% WW 829 927 -10.6% -10.5% -0.1% XARELTO US 518 578 -10.4% -10.4% - Intl - - - - - WW 518 578 -10.4% -10.4% - OTHER US 114 137 -17.1% -17.1% - Intl 197 212 -7.0% -6.8% -0.2% WW 311 349 -11.0% -10.9% -0.1% TOTAL INNOVATIVE MEDICINE US 7,612 7,023 8.4% 8.4% - Intl 5,950 6,390 -6.9% -4.0% -2.9% WW $ 13,562 13,413 1.1% 2.5% -1.4% See footnotes at end of schedule REPORTED SALES vs. PRIOR PERIOD ($MM) FIRST QUARTER % Change MEDTECH SEGMENT (2) 2024 2023 Reported Operational (1) Currency CARDIOVASCULAR (5) US $ 1,025 863 18.8% 18.8% - Intl 781 640 22.1% 27.6% -5.5% WW 1,806 1,503 20.2% 22.5% -2.3% ELECTROPHYSIOLOGY US 692 571 21.3% 21.3% - Intl 652 522 24.9% 30.9% -6.0% WW 1,344 1,092 23.0% 25.9% -2.9% ABIOMED US 303 264 15.0% 15.0% - Intl 67 60 12.4% 14.7% -2.3% WW 371 324 14.5% 15.0% -0.5% OTHER CARDIOVASCULAR (5) US 30 28 3.3% 3.3% - Intl 62 58 6.9% 11.5% -4.6% WW 92 87 5.7% 8.8% -3.1% ORTHOPAEDICS US 1,448 1,363 6.2% 6.2% - Intl 892 881 1.3% 2.7% -1.4% WW 2,340 2,245 4.3% 4.8% -0.5% HIPS US 270 241 12.1% 12.1% - Intl 152 149 1.7% 3.3% -1.6% WW 422 390 8.1% 8.7% -0.6% KNEES US 242 226 6.9% 6.9% - Intl 160 142 12.3% 13.1% -0.8% WW 401 368 9.0% 9.3% -0.3% TRAUMA US 504 491 2.8% 2.8% - Intl 261 267 -2.3% -1.1% -1.2% WW 765 757 1.0% 1.4% -0.4% SPINE, SPORTS & OTHER US 432 406 6.5% 6.5% - Intl 320 323 -0.9% 0.9% -1.8% WW 752 729 3.2% 4.0% -0.8% REPORTED SALES vs. PRIOR PERIOD ($MM) FIRST QUARTER % Change 2024 2023 Reported Operational (1) Currency SURGERY US 987 975 1.2% 1.2% - Intl 1,429 1,459 -2.0% 2.3% -4.3% WW 2,416 2,434 -0.7% 1.9% -2.6% ADVANCED US 446 444 0.2% 0.2% - Intl 641 673 -4.7% -0.7% -4.0% WW 1,087 1,118 -2.8% -0.3% -2.5% GENERAL US 542 531 2.1% 2.1% - Intl 788 785 0.3% 4.8% -4.5% WW 1,330 1,316 1.0% 3.7% -2.7% VISION US 547 558 -1.8% -1.8% - Intl 710 743 -4.4% -1.1% -3.3% WW 1,258 1,300 -3.3% -1.4% -1.9% CONTACT LENSES / OTHER US 438 444 -1.4% -1.4% - Intl 472 509 -7.4% -3.1% -4.3% WW 910 953 -4.6% -2.3% -2.3% SURGICAL US 110 114 -3.7% -3.7% - Intl 238 233 2.2% 3.4% -1.2% WW 348 347 0.3% 1.1% -0.8% TOTAL MEDTECH US 4,008 3,759 6.6% 6.6% - Intl 3,813 3,722 2.4% 6.1% -3.7% WW $ 7,821 $ 7,481 4.5% 6.3% -1.8% Note: Columns and rows within tables may not add due to rounding. Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely * Percentage greater than 100% or not meaningful (1) Operational growth excludes the effect of translational currency (2) Unaudited (3) Reported as U.S. sales (4) See Supplemental Sales Information Schedule (5) Previously referred to as Interventional Solutions Supplemental Sales Information (Unaudited) (Dollars in Millions) Schedule 1 FIRST QUARTER Percent Change 2024 2023 Total Operations Currency Innovative Medicine U.S. $ 7,612 7,023 8.4 % 8.4 - International 5,950 6,390 (6.9 ) (4.0 ) (2.9 ) Worldwide 13,562 13,413 1.1 2.5 (1.4 ) COVID-19 Vaccine U.S. - - - - - International 25 747 (96.6 ) (96.7 ) 0.1 Worldwide 25 747 (96.6 ) (96.7 ) 0.1 Innovative Medicine excluding COVID-19 Vaccine U.S. 7,612 7,023 8.4 8.4 - International 5,925 5,643 5.0 8.3 (3.3 ) Worldwide 13,537 12,666 6.9 8.3 (1.4 ) Worldwide U.S. 11,620 10,782 7.8 7.8 - International 9,763 10,112 (3.4 ) (0.3 ) (3.1 ) Worldwide 21,383 20,894 2.3 3.9 (1.6 ) COVID-19 Vaccine U.S. - - - - - International 25 747 (96.6 ) (96.7 ) 0.1 Worldwide 25 747 (96.6 ) (96.7 ) 0.1 Worldwide U.S. 11,620 10,782 7.8 7.8 - International 9,738 9,365 4.0 7.4 (3.4 ) Worldwide excluding COVID-19 Vaccine $ 21,358 20,147 6.0 % 7.6 (1.6 ) Europe $ 5,163 5,590 (7.6 ) % (7.7 ) 0.1 Europe COVID-19 Vaccine Sales 25 747 (96.6 ) (96.7 ) 0.1 Europe excluding COVID-19 Vaccine Sales $ 5,138 4,843 6.1 % 6.0 0.1 Schedule 2 2022 2023 2023 Full Year Q1 Q2 Q3 Q4 Full Year INNOVATIVE MEDICINE SEGMENT (1) ONCOLOGY TECVAYLI US 12 57 82 93 102 334 INTL 3 6 12 19 24 61 WW 15 63 94 112 126 395 OTHER ONCOLOGY US 144 35 40 50 90 215 INTL 280 64 80 67 58 269 WW 423 99 120 117 148 484 Note: Columns and rows within tables may not add due to rounding (1) Unaudited Johnson & Johnson and Subsidiaries Reconciliation of Non-GAAP Financial Measures Q1 YTD - Income Before Tax and Research & Development Expense by Segment* Dollars in Millions Innovative Medicine MedTech Unallocated Worldwide Total 2024 2023 2024 2023 2024 2023 2024 2023 Reported Income Before Tax by Segment From Continuing Operations $ 4,969 4,402 1,520 1,409 (49 ) (7,098 ) 6,440 (1,287 ) % to Sales 36.6 % 32.8 % 19.4 % 18.8 % -0.2 % -34.0 % 30.1 % -6.2 % Intangible asset amortization expense 698 739 380 383 - - 1,078 1,122 In-process research and development impairments - - - 49 - - - 49 Litigation related - - - - - 6,900 - 6,900 Loss/(gain) on securities (55 ) 38 22 34 13 - (20 ) 72 Restructuring related 144 130 27 - - - 171 130 Acquisition, integration and divestiture related 47 - 61 42 40 - 148 42 Medical Device Regulation - - 51 64 - - 51 64 COVID-19 Vaccine related costs 9 444 - - - - 9 444 Adjusted Income Before Tax by Segment From Continuing Operations $ 5,812 5,753 2,061 1,981 4 (198 ) 7,877 7,536 % to Sales 42.9 % 42.9 % 26.4 % 26.5 % 0.0 % -0.9 % 36.8 % 36.1 % *Estimated as of 4/16/2024 As Reported Research and development expense $ 2,896 2,778 646 677 3,542 3,455 % to Sales 21.4 % 20.7 % 8.3 % 9.1 % 16.6 % 16.6 % Johnson & Johnson and Subsidiaries GAAP to Non-GAAP Reconciliation $ in Millions Year to Date First Quarter March 31, 2024 GAAP Intangible asset amortization Litigation related In-process research and development impairments Restructuring related Acquisition, integration and divestiture related (Loss)/gain on securities Medical Device Regulation COVID-19 Vaccine Related Costs Tax legislation and other tax related First Quarter March 31, 2024 Non-GAAP Cost of products sold $ 6,511 (1,078 ) (7 ) (20 ) (2 ) - 5,404 Selling, marketing and admin expenses 5,257 (4 ) 5,253 Research and development expense 3,542 (18 ) (27 ) (7 ) 3,490 Other (Income) / Expense (322 ) - - - (130 ) 20 - - (432 ) In-process research and development impairments - - - Restructuring 164 (164 ) - Provision for taxes on income 1,086 148 - - 39 38 (7 ) 9 2 (18 ) 1,297 Net Earnings from Continuing Operations 5,354 930 - - 132 110 (13 ) 42 7 18 6,580 First Quarter April 2, 2023 GAAP Intangible asset amortization Litigation related In-process research and development impairments Restructuring related Acquisition, integration and divestiture related (Loss)/gain on securities Medical Device Regulation COVID-19 Vaccine Related Costs Tax legislation and other tax related First Quarter April 2, 2023 Non-GAAP Cost of products sold $ 6,687 (1,118 ) - (23 ) (206 ) - 5,340 Selling, marketing and admin expenses 4,906 (7 ) 4,899 Research and development expense 3,455 (16 ) (34 ) (16 ) 3,389 Other (Income) / Expense 6,940 (4 ) (6,900 ) - (26 ) (72 ) (222 ) (284 ) In-process research and development impairments 49 (49 ) - Restructuring 130 (130 ) - Provision for (Benefit from) taxes on income (796 ) 177 1,622 11 32 5 16 12 105 12 1,196 Net Earnings (Loss) from Continuing Operations (491 ) 945 5,278 38 98 37 56 52 339 (12 ) 6,340 View source version on businesswire.com: Contacts Media contact: Tesia Williams media-relations@its.jnj.com Investor contact: Jessica Moore investor-relations@its.jnj.com Source: Johnson & Johnson View this news release online at: