Alzheimer Disease, Familial, 1

2024 Fourth-Quarter reported sales growth of 5.3% to $22.5 Billion with operational growth of 6.7%* and adjusted operational growth of 5.7%* 2024 Fourth-Quarter Earnings per share (EPS) of $1.41 and Adjusted EPS of $2.04, both include $(0.22) due to acquired IPR&D charges related to V-Wave acquisition 2024 Full-Year reported sales growth of 4.3% to $88.8 Billion with operational growth of 5.9%* and adjusted operational growth of 5.4%*. Operational growth excluding COVID-19 Vaccine of 7.0%* 2024 Full-Year Earnings per share (EPS) of $5.79 and Adjusted EPS of $9.98, both include $(0.67) due to acquired IPR&D charges on various transactions throughout the year Significant pipeline progress including RYBREVANT + LAZCLUZE overall survival data, initiation of TAR-200 submission, and approval of investigational device exemption for our general surgery robotic system, OTTAVA Company issues guidance for 2025 with operational sales5 growth of 2.5% - 3.5%* and adjusted operational EPS of $10.75 - $10.95, reflecting strong growth of 8.7%* at the mid-point NEW BRUNSWICK, N.J.--(BUSINESS WIRE)-- Johnson & Johnson (NYSE: JNJ) today announced results for fourth-quarter and full year 2024. "2024 was a transformative year for Johnson & Johnson, marked by strong growth, an accelerating pipeline and industry-leading investments in innovation,” said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. “As a healthcare company, with a disease-centric approach, we are improving the standard of care in a broad range of diseases with high unmet need, including multiple myeloma, lung cancer, inflammatory bowel disease, and heart failure. With our strong financial foundation, differentiated portfolio and robust pipeline, we are well positioned to sustain the high pace of growth and innovation that is the hallmark of Johnson & Johnson.” Unless otherwise noted, the financial results and earnings guidance included below reflect the continuing operations of Johnson & Johnson. Overall financial results Q4 Full Year ($ in Millions, expect EPS) 2024 2023 % Change 2024 2023 % Change Reported Sales $22,520 $ 21,395 5.3% $88,821 $ 85,159 4.3% Net Earnings $3,431 $4,132 (17.0)% $14,066 $13,326 5.6% EPS (diluted) $1.41 $1.70 (17.1)% $5.79 $5.20 11.3% Q4 Full Year Non-GAAP* ($ in Millions, except EPS) 2024 2023 % Change 2024 2023 % Change Operational Sales1,2 6.7% 5.9% Adjusted Operational Sales1,3 5.7% 5.4% Adjusted Operational Sales1,3 ex. COVID-19 Vaccine 5.9% 6.5% Adjusted Net Earnings1,4 $4,946 $5,562 (11.1)% $ 24,242 $ 25,409 (4.6)% Adjusted EPS (diluted)1,4 $2.04 $2.29 (10.9)% $9.98 $9.92 0.6% Free Cash Flow6,7 ~$19,800 $18,248 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency 4 Excludes intangible amortization expense and special items 5 Excludes COVID-19 Vaccine 6 Non-GAAP measure; defined as cash flow from operating activities, less additions to property, plant and equipment. Cash flow from operations, the most directly comparable GAAP financial measure, will be included in subsequent SEC filings. 7 Full year 2024 is estimated as of January 22, 2025. Full year 2023 includes approximately 8 months contribution from the Consumer Health segment. Note: values may have been rounded Regional sales results Q4 % Change ($ in Millions) 2024 2023 Reported Operational1,2 Currency Adjusted Operational1,3 U.S. $13,204 $12,009 10.0% 10.0 - 8.6 International 9,316 9,386 (0.7) 2.5 (3.2) 2.0 Worldwide $22,520 $21,395 5.3% 6.7 (1.4) 5.7 Full Year % Change ($ in Millions) 2024 2023 Reported Operational1,2 Currency Adjusted Operational1,3 U.S. $50,302 $46,444 8.3% 8.3 - 7.6 International 38,519 38,715 (0.5) 2.9 (3.4) 2.7 Worldwide $88,821 $85,159 4.3% 5.9 (1.6) 5.4 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency Note: values may have been rounded Segment sales results Q4 % Change ($ in Millions) 2024 2023 Reported Operational1,2 Currency Adjusted Operational1,3 Innovative Medicine $14,332 $13,722 4.4% 6.1 (1.7) 6.3 MedTech 8,188 7,673 6.7 7.6 (0.9) 4.6 Worldwide $22,520 $21,395 5.3% 6.7 (1.4) 5.7 Full Year % Change ($ in Millions) 2024 2023 Reported Operational1,2 Currency Adjusted Operational1,3 Innovative Medicine $56,964 $54,759 4.0% 5.7 (1.7) 5.8 MedTech 31,857 30,400 4.8 6.2 (1.4) 4.7 Worldwide $88,821 $85,159 4.3% 5.9 (1.6) 5.4 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency Note: values may have been rounded Full year 2024 segment commentary: Operational sales* reflected below excludes the impact of translational currency. Innovative Medicine Innovative Medicine worldwide operational sales, excluding the COVID-19 Vaccine, grew 7.5%*. Growth was driven primarily by DARZALEX (daratumumab), ERLEADA (apalutamide), CARVYKTI (ciltacabtagene autoleucel), and Other Oncology in Oncology, TREMFYA (guselkumab) in Immunology, and SPRAVATO (esketamine) in Neuroscience. Growth was partially offset by STELARA (ustekinumab) in Immunology and Other Neuroscience in Neuroscience. Including the COVID-19 Vaccine, Innovative Medicine worldwide operational sales grew 5.7%*. MedTech MedTech worldwide operational sales grew 6.2%*, with net acquisitions and divestitures positively impacting growth by 1.5%. Growth was driven primarily by electrophysiology products and Abiomed in Cardiovascular, previously referred to as Interventional Solutions, and wound closure products in General Surgery. Full-year 2025 guidance: Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses, and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson's results computed in accordance with GAAP. ($ in Billions, except EPS) January 2025 Adjusted Operational Sales1,2,5 Change vs. Prior Year / Mid-point 2.0% – 3.0% / 2.5% Operational Sales2,5 / Mid-point Change vs. Prior Year / Mid-point $90.9B – $91.7B / $91.3B 2.5% – 3.5% / 3.0% Estimated Reported Sales3,5 / Mid-point Change vs. Prior Year / Mid-point $89.2B – $90.0B / $89.6B 0.5% – 1.5% / 1.0% Adjusted Operational EPS (Diluted)2,4 / Mid-point Change vs. Prior Year / Mid-point $10.75 – $10.95 / $10.85 7.7% – 9.7% / 8.7% Adjusted EPS (Diluted)3,4 / Mid-point Change vs. Prior Year / Mid-point $10.50 – $10.70 / $10.60 5.2% – 7.2% / 6.2% 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: January 2025 = $1.04 (Illustrative purposes only) 4 Non-GAAP financial measure; excludes intangible amortization expense and special items 5 Excludes COVID-19 Vaccine Other modeling considerations will be provided on the webcast. Notable 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 www.sec.gov, www.jnj.com 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 www.factsabouttalc.com. Regulatory SPRAVATO (esketamine) approved in the U.S. as the first and only monotherapy for adults with treatment-resistant depression1 Press Release European Commission approves LAZCLUZE (lazertinib) in combination with RYBREVANT (amivantamab) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer1 Press Release New Drug Application initiated with U.S. FDA for TAR-200, the first and only intravesical drug releasing system for patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer1 Press Release Johnson & Johnson MedTech Announces CE Mark Approval for Dual Energy THERMOCOOL SMARTTOUCH SF Catheter1 Press Release Nipocalimab granted U.S. FDA Priority Review for the treatment of generalized myasthenia gravis1 Press Release Johnson & Johnson's Posdinemab and Tau Active Immunotherapy Receive U.S. FDA Fast Track Designations for the Treatment of Alzheimer's Disease1 Press Release European Commission approves RYBREVANT (amivantamab) in combination with LAZCLUZE (lazertinib) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer Press Release Johnson & Johnson submits application to the European Medicines Agency seeking approval of a new indication for IMBRUVICA (ibrutinib) in adult patients with previously untreated mantle cell lymphoma (MCL) who are eligible for autologous stem cell transplant Press Release U.S. FDA Expands Indication for Impella Heart Pumps to Treat Pediatric Patients Press Release Johnson & Johnson seeks U.S. FDA approval for first pediatric indications for TREMFYA (guselkumab) Press Release Johnson & Johnson seeks U.S. FDA approval for subcutaneous induction regimen of TREMFYA (guselkumab) in ulcerative colitis, a first for an IL-23 inhibitor Press Release Johnson & Johnson MedTech Receives IDE Approval for OTTAVA Robotic Surgical System Press Release Nipocalimab is the first and only investigational therapy granted U.S. FDA Breakthrough Therapy Designation for the treatment of adults living with moderate-to-severe Sjögren's disease Press Release Johnson & Johnson submits applications in the U.S. and EU seeking approval of DARZALEX FASPRO / DARZALEX as subcutaneous monotherapy for high-risk smoldering multiple myeloma Press Release DARZALEX (daratumumab)-SC based quadruplet regimen approved by the European Commission for patients with newly diagnosed multiple myeloma who are transplant-eligible Press Release Data Releases RYBREVANT (amivantamab-vmjw) plus LAZCLUZE (lazertinib) show statistically significant and clinically meaningful improvement in overall survival versus osimertinib1 Press Release Johnson & Johnson to showcase strength of its broad hematology portfolio and pipeline at the 2024 American Society of Hematology Annual Meeting Press Release Icotrokinra delivered an industry-leading combination of significant skin clearance with demonstrated tolerability in a once daily pill in Phase 3 topline results Press Release Johnson & Johnson advances leadership in rheumatic disease innovation with 43 abstracts at ACR 2024 Press Release Shockwave Medical Unveils First Clinical Outcomes of New IVL Platform in Late-Breaking Presentation at VIVA 2024 Press Release TREMFYA (guselkumab) is the first and only IL-23 inhibitor to demonstrate robust results with a fully subcutaneous regimen in both induction and maintenance in Crohn's disease Press Release New SPECTREM study findings reveal TREMFYA (guselkumab) effectively clears overlooked and undertreated plaque psoriasis Press Release Johnson & Johnson highlights innovative neuropsychiatry portfolio and pipeline at Psych Congress Press Release Nipocalimab demonstrates sustained disease control in adolescents living with generalized myasthenia gravis in Phase 2/3 study Press Release Product Launch MENTOR MemoryGel Enhance Breast Implant Receives FDA Approval for Largest Size Breast Implants for Reconstruction Press Release Johnson & Johnson MedTech Receives FDA Approval for the VARIPULSE Pulsed Field Ablation Platform for the Treatment of Atrial Fibrillation2 Press Release Other Johnson & Johnson Strengthens Neuroscience Leadership with Acquisition of Intra-Cellular Therapies, Inc.1 Press Release 1 Subsequent to the quarter 2 On January 5, 2025, Johnson & Johnson MedTech temporarily paused the U.S. External Evaluation and all U.S. VARIPULSE cases. More information can be found in the Statement on VARIPULSE. Webcast information: Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:00 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 www.jnj.com. 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; and the Company’s ability to realize the anticipated benefits from the separation of Kenvue Inc. 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 www.sec.gov, www.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. 2024 2023 Total Operations Currency 2024 2023 $ 8,977 8,079 11.1 % 11.1 - $ 33,970 31,169 9.0 % 9.0 - 5,355 5,643 (5.1 ) (1.0 ) (4.1 ) 22,994 23,590 (2.5 ) 1.3 (3.8 ) 14,332 13,722 4.4 6.1 (1.7 ) 56,964 54,759 4.0 5.7 (1.7 ) 8,977 8,079 11.1 11.1 - 33,970 31,169 9.0 9.0 - 5,355 5,599 (4.4 ) (0.3 ) (4.1 ) 22,796 22,473 1.4 5.5 (4.1 ) 14,332 13,678 4.8 6.5 (1.7 ) 56,766 53,642 5.8 7.5 (1.7 ) 4,227 3,930 7.6 7.6 - 16,332 15,275 6.9 6.9 - 3,961 3,743 5.8 7.6 (1.8 ) 15,525 15,125 2.6 5.4 (2.8 ) 8,188 7,673 6.7 7.6 (0.9 ) 31,857 30,400 4.8 6.2 (1.4 ) 13,204 12,009 10.0 10.0 - 50,302 46,444 8.3 8.3 - 9,316 9,386 (0.7 ) 2.5 (3.2 ) 38,519 38,715 (0.5 ) 2.9 (3.4 ) 22,520 21,395 5.3 6.7 (1.4 ) 88,821 85,159 4.3 5.9 (1.6 ) 13,204 12,009 10.0 10.0 - 50,302 46,444 8.3 8.3 - 9,316 9,342 (0.3 ) 2.9 (3.2 ) 38,321 37,598 1.9 5.5 (3.6 ) $ 22,520 21,351 5.5 % 6.9 (1.4 ) $ 88,623 84,042 5.5 % 7.0 (1.5 ) FOURTH QUARTER TWELVE MONTHS Percent Change Percent Change 2024 2023 Total Operations Currency 2024 2023 Total Operations Currency $ 13,204 12,009 10.0 % 10.0 - $ 50,302 46,444 8.3 % 8.3 - 4,921 4,962 (0.8 ) (0.2 ) (0.6 ) 20,212 20,410 (1.0 ) (0.6 ) (0.4 ) 1,135 1,166 (2.7 ) 17.6 (20.3 ) 4,714 4,549 3.6 20.4 (16.8 ) 3,260 3,258 0.1 0.9 (0.8 ) 13,593 13,756 (1.2 ) 2.3 (3.5 ) 9,316 9,386 (0.7 ) 2.5 (3.2 ) 38,519 38,715 (0.5 ) 2.9 (3.4 ) $ 22,520 21,395 5.3 % 6.7 (1.4 ) $ 88,821 85,159 4.3 % 5.9 (1.6 ) FOURTH QUARTER TWELVE MONTHS Percent Change Percent Change 2024 2023 Total Operations Currency 2024 2023 Total Operations Currency $ 13,204 12,009 10.0 % 10.0 - $ 50,302 46,444 8.3 % 8.3 - 4,921 4,918 0.1 0.7 (0.6 ) 20,014 19,293 3.7 4.1 (0.4 ) 1,135 1,166 (2.7 ) 17.6 (20.3 ) 4,714 4,549 3.6 20.4 (16.8 ) 3,260 3,258 0.1 0.9 (0.8 ) 13,593 13,756 (1.2 ) 2.3 (3.5 ) 9,316 9,342 (0.3 ) 2.9 (3.2 ) 38,321 37,598 1.9 5.5 (3.6 ) $ 22,520 21,351 5.5 % 6.9 (1.4 ) $ 88,623 84,042 5.5 % 7.0 (1.5 ) 2024 2023 Percent Percent Percent Increase Amount to Sales Amount to Sales (Decrease) $ 22,520 100.0 $ 21,395 100.0 5.3 7,128 31.6 6,798 31.8 4.9 15,392 68.4 14,597 68.2 5.4 6,453 28.6 5,810 27.1 11.1 5,298 23.5 4,480 20.9 18.3 17 0.1 58 0.3 (144 ) (0.6 ) (212 ) (1.0 ) (161 ) (0.7 ) (421 ) (2.0 ) 42 0.2 56 0.3 3,887 17.3 4,826 22.6 (19.5 ) 456 2.1 694 3.3 (34.3 ) $ 3,431 15.2 $ 4,132 19.3 (17.0 ) - (83 ) $ 3,431 $ 4,049 $ 1.41 $ 1.70 (17.1 ) $ - $ (0.03 ) 2,427.1 2,430.7 11.7 % 14.4 % $ 5,421 24.1 $ 6,237 29.2 (13.1 ) $ 4,946 22.0 $ 5,562 26.0 (11.1 ) $ 2.04 $ 2.29 (10.9 ) 8.8 % 10.8 % 2024 2023 Percent Percent Percent Increase Amount to Sales Amount to Sales (Decrease) $ 88,821 100.0 $ 85,159 100.0 4.3 27,471 30.9 26,553 31.2 3.5 61,350 69.1 58,606 68.8 4.7 22,869 25.7 21,512 25.2 6.3 17,232 19.4 15,085 17.7 14.2 211 0.2 313 0.4 (577 ) (0.6 ) (489 ) (0.6 ) 4,694 5.3 6,634 7.8 234 0.3 489 0.6 16,687 18.8 15,062 17.7 10.8 2,621 3.0 1,736 2.1 51.0 $ 14,066 15.8 $ 13,326 15.6 5.6 - 21,827 $ 14,066 $ 35,153 $ 5.79 $ 5.20 11.3 $ - $ 8.52 2,429.4 2,560.4 15.7 % 11.5 % $ 28,979 32.6 $ 29,811 35.0 (2.8 ) $ 24,242 27.3 $ 25,409 29.8 (4.6 ) $ 9.98 $ 9.92 0.6 16.3 % 14.8 % 2024 2023 2024 2023 $3,431 $4,132 $14,066 $13,326 (16) 166 5,450 7,152 1,171 1,148 4,526 4,532 23 10 100 663 62 139 269 798 47 88 204 311 298 237 1,226 339 (68) (435) 306 641 17 58 211 313 (80) 75 (2,135) (2,694) 61 (56) 19 28 $4,946 $5,562 $24,242 $25,409 2,427.1 2,430.7 2,429.4 2,560.4 $2.04 $2.29 $9.98 $9.92 $2.05 $9.99 1 2 3 4 4.4 % 6.7 % 5.3 % 11.1 % 7.6 % 10.0 % (5.1 )% 5.8 % (0.7 )% (1.7 ) (0.9 ) (1.4 ) - - - (4.1 ) (1.8 ) (3.2 ) 6.1 % 7.6 % 6.7 % 11.1 % 7.6 % 10.0 % (1.0 )% 7.6 % 2.5 % (3.4 ) (1.2 ) (5.1 ) (1.7 ) (1.5 ) (0.6 ) 0.2 0.4 0.2 0.1 0.8 0.3 0.3 0.0 0.1 6.3 % 4.6 % 5.7 % 11.2 % 3.3 % 8.6 % (0.7 )% 6.1 % 2.0 % 0.4 0.2 0.0 0.0 0.7 0.4 6.7 % 4.6 % 5.9 % 11.2 % 3.3 % 8.6 % 0.0 % 6.1 % 2.4 % 4.0 % 4.8 % 4.3 % 9.0 % 6.9 % 8.3 % (2.5 )% 2.6 % (0.5 )% (1.7 ) (1.4 ) (1.6 ) - - - (3.8 ) (2.8 ) (3.4 ) 5.7 % 6.2 % 5.9 % 9.0 % 6.9 % 8.3 % 1.3 % 5.4 % 2.9 % (1.9 ) (0.7 ) (2.9 ) (1.0 ) (0.8 ) (0.3 ) 0.1 0.4 0.2 0.1 0.8 0.3 0.2 0.1 0.1 5.8 % 4.7 % 5.4 % 9.1 % 4.8 % 7.6 % 1.5 % 4.7 % 2.7 % 1.8 1.1 0.0 0.0 4.2 2.6 7.6 % 4.7 % 6.5 % 9.1 % 4.8 % 7.6 % 5.7 % 4.7 % 5.3 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) FOURTH QUARTER TWELVE MONTHS % Change % Change 2024 2023 Reported Operational (1) Currency 2024 2023 Reported Operational (1) Currency $ 2,856 3,033 -5.9 % -5.9 % - $ 11,355 11,539 -1.6 % -1.6 % - 1,383 1,562 -11.5 % -6.5 % -5.0 % 6,473 6,513 -0.6 % 4.0 % -4.6 % 4,238 4,595 -7.8 % -6.1 % -1.7 % 17,828 18,052 -1.2 % 0.4 % -1.6 % 231 294 -21.4 % -21.4 % - 1,009 1,143 -11.7 % -11.7 % - 9 35 -73.3 % -73.3 % - 98 147 -33.0 % -33.0 % - 117 100 16.5 % 22.9 % -6.4 % 497 549 -9.5 % -5.0 % -4.5 % 359 429 -16.5 % -15.0 % -1.5 % 1,605 1,839 -12.8 % -11.4 % -1.4 % 262 258 1.3 % 1.3 % - 1,082 1,124 -3.8 % -3.8 % - 321 244 32.1 % 44.2 % -12.1 % 1,108 1,073 3.3 % 13.2 % -9.9 % 583 502 16.2 % 22.1 % -5.9 % 2,190 2,197 -0.3 % 4.5 % -4.8 % 1,699 1,786 -4.9 % -4.9 % - 6,720 6,966 -3.5 % -3.5 % - 650 967 -32.7 % -29.6 % -3.1 % 3,641 3,892 -6.4 % -3.3 % -3.1 % 2,349 2,753 -14.7 % -13.6 % -1.1 % 10,361 10,858 -4.6 % -3.4 % -1.2 % 654 657 -0.6 % -0.6 % - 2,443 2,147 13.7 % 13.7 % - 295 252 16.9 % 21.7 % -4.8 % 1,227 999 22.8 % 27.6 % -4.8 % 949 910 4.2 % 5.6 % -1.4 % 3,670 3,147 16.6 % 18.1 % -1.5 % 0 2 - 3 11 -74.1 % -74.1 % - 0 0 - - - 0 0 - - - 0 2 3 11 -74.1 % -74.1 % - 331 353 -6.4 % -6.4 % - 1,354 1,500 -9.8 % -9.8 % - 443 498 -11.2 % -9.8 % -1.4 % 2,042 2,918 -30.0 % -29.3 % -0.7 % 774 852 -9.2 % -8.4 % -0.8 % 3,396 4,418 -23.1 % -22.7 % -0.4 % 0 0 - - - 0 0 - - - 0 44 198 1,117 -82.4 % -82.4 % 0.0 % 0 44 198 1,117 -82.4 % -82.4 % 0.0 % 7 9 -10.1 % -10.1 % - 31 35 -10.0 % -10.0 % - 315 299 5.0 % 5.6 % -0.6 % 1,241 1,115 11.2 % 11.2 % 0.0 % 322 307 4.6 % 5.1 % -0.5 % 1,272 1,150 10.6 % 10.6 % 0.0 % 321 341 -5.8 % -5.8 % - 1,311 1,446 -9.4 % -9.4 % - 86 98 -12.9 % -8.9 % -4.0 % 401 408 -1.7 % 1.1 % -2.8 % 407 439 -7.4 % -6.5 % -0.9 % 1,712 1,854 -7.7 % -7.1 % -0.6 % 1 4 -53.1 % -53.1 % - 11 19 -41.0 % -41.0 % - 43 58 -24.2 % -22.4 % -1.8 % 203 278 -26.7 % -23.9 % -2.8 % 45 62 -26.1 % -24.4 % -1.7 % 214 297 -27.6 % -25.0 % -2.6 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) FOURTH QUARTER TWELVE MONTHS % Change % Change 2024 2023 Reported Operational (1) Currency 2024 2023 Reported Operational (1) Currency 1,148 1,022 12.3 % 12.3 % - 4,398 4,065 8.2 % 8.2 % - 628 780 -19.6 % -16.8 % -2.8 % 2,718 3,076 -11.6 % -7.8 % -3.8 % 1,775 1,801 -1.5 % -0.3 % -1.2 % 7,115 7,140 -0.4 % 1.3 % -1.7 % 33 39 -12.8 % -12.8 % - 134 230 -41.7 % -41.7 % - 125 142 -11.5 % -7.7 % -3.8 % 507 554 -8.4 % -4.1 % -4.3 % 159 180 -11.7 % -8.8 % -2.9 % 641 783 -18.1 % -15.1 % -3.0 % 796 733 8.6 % 8.6 % - 3,125 2,897 7.9 % 7.9 % - 267 278 -4.0 % -1.8 % -2.2 % 1,097 1,218 -9.9 % -7.1 % -2.8 % 1,063 1,011 5.1 % 5.7 % -0.6 % 4,222 4,115 2.6 % 3.4 % -0.8 % 269 180 50.1 % 50.1 % - 929 589 57.8 % 57.8 % - 28 26 7.1 % 12.5 % -5.4 % 148 100 48.2 % 51.2 % -3.0 % 297 206 44.6 % 45.3 % -0.7 % 1,077 689 56.4 % 56.8 % -0.4 % 49 71 -31.0 % -31.0 % - 210 349 -39.8 % -39.8 % - 206 334 -38.1 % -35.4 % -2.7 % 965 1,204 -19.8 % -15.1 % -4.7 % 255 404 -36.9 % -34.6 % -2.3 % 1,175 1,553 -24.3 % -20.7 % -3.6 % 3,019 2,285 32.2 % 32.2 % - 10,854 8,462 28.3 % 28.3 % - 2,476 2,334 6.1 % 10.6 % -4.5 % 9,926 9,199 7.9 % 12.1 % -4.2 % 5,497 4,618 19.0 % 21.3 % -2.3 % 20,781 17,661 17.7 % 19.8 % -2.1 % 304 145 - 869 469 85.2 % 85.2 % - 31 13 94 30 334 159 963 500 92.7 % 92.7 % 0.0 % 1,799 1,395 28.9 % 28.9 % - 6,588 5,277 24.8 % 24.8 % - 1,285 1,155 11.3 % 17.0 % -5.7 % 5,082 4,467 13.8 % 19.1 % -5.3 % 3,084 2,550 20.9 % 23.5 % -2.6 % 11,670 9,744 19.8 % 22.2 % -2.4 % 342 287 19.0 % 19.0 % - 1,282 1,065 20.3 % 20.3 % - 442 361 22.4 % 25.7 % -3.3 % 1,717 1,322 29.8 % 32.9 % -3.1 % 784 647 20.9 % 22.7 % -1.8 % 2,999 2,387 25.6 % 27.3 % -1.7 % 250 255 -2.0 % -2.0 % - 1,020 1,051 -3.0 % -3.0 % - 481 533 -9.6 % -6.8 % -2.8 % 2,018 2,214 -8.8 % -6.3 % -2.5 % 731 788 -7.2 % -5.2 % -2.0 % 3,038 3,264 -6.9 % -5.2 % -1.7 % 108 102 5.6 % 5.6 % - 418 334 25.3 % 25.3 % - 38 24 59.9 % 71.6 % -11.7 % 131 61 146 126 15.8 % 18.0 % -2.2 % 549 395 38.8 % 39.8 % -1.0 % 9 9 -7.3 % -7.3 % - 34 50 -32.2 % -32.2 % - 127 191 -33.6 % -30.7 % -2.9 % 597 837 -28.6 % -24.6 % -4.0 % 135 201 -32.4 % -29.6 % -2.8 % 631 887 -28.8 % -25.0 % -3.8 % 208 90 - 643 215 - 74 58 25.5 % 30.6 % -5.1 % 288 269 7.1 % 10.4 % -3.3 % 282 148 90.4 % 92.4 % -2.0 % 931 484 92.5 % 94.3 % -1.8 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) FOURTH QUARTER TWELVE MONTHS % Change % Change 2024 2023 Reported Operational (1) Currency 2024 2023 Reported Operational (1) Currency 819 733 11.6 % 11.6 % - 3,143 2,697 16.5 % 16.5 % - 274 282 -3.2 % 1.2 % -4.4 % 1,140 1,117 2.0 % 8.2 % -6.2 % 1,092 1,017 7.4 % 8.7 % -1.3 % 4,282 3,815 12.3 % 14.1 % -1.8 % 385 368 4.8 % 4.8 % - 1,520 1,292 17.7 % 17.7 % - 160 169 -5.2 % -2.5 % -2.7 % 664 681 -2.4 % 1.1 % -3.5 % 545 536 1.7 % 2.5 % -0.8 % 2,184 1,973 10.7 % 11.9 % -1.2 % 391 348 12.3 % 12.3 % - 1,511 1,326 13.9 % 13.9 % - 75 70 5.7 % 11.2 % -5.5 % 307 255 20.1 % 27.3 % -7.2 % 465 419 11.2 % 12.1 % -0.9 % 1,817 1,582 14.9 % 16.1 % -1.2 % 42 18 - 112 79 41.8 % 41.8 % - 40 45 -10.0 % -0.4 % -9.6 % 169 182 -6.9 % 8.2 % -15.1 % 82 61 32.3 % 39.3 % -7.0 % 281 260 7.9 % 18.3 % -10.4 % 805 652 23.3 % 23.3 % - 2,866 2,906 -1.4 % -1.4 % - 153 185 -17.6 % -15.1 % -2.5 % 696 765 -9.1 % -7.1 % -2.0 % 957 837 14.3 % 14.8 % -0.5 % 3,562 3,671 -3.0 % -2.6 % -0.4 % 676 525 28.5 % 28.5 % - 2,373 2,365 0.3 % 0.3 % - - - - - - - - - - - 676 525 28.5 % 28.5 % - 2,373 2,365 0.3 % 0.3 % - 130 127 1.5 % 1.5 % - 494 541 -8.8 % -8.8 % - 153 185 -17.6 % -15.1 % -2.5 % 696 765 -9.1 % -7.1 % -2.0 % 281 312 -9.8 % -8.3 % -1.5 % 1,189 1,306 -8.9 % -7.8 % -1.1 % 8,977 8,079 11.1 % 11.1 % - 33,970 31,169 9.0 % 9.0 % - 5,355 5,643 -5.1 % -1.0 % -4.1 % 22,994 23,590 -2.5 % 1.3 % -3.8 % $ 14,332 $ 13,722 4.4 % 6.1 % -1.7 % $ 56,964 54,759 4.0 % 5.7 % -1.7 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) FOURTH QUARTER TWELVE MONTHS % Change % Change 2024 2023 Reported Operational (1) Currency 2024 2023 Reported Operational (1) Currency $ 1,221 971 25.8 % 25.8 % - $ 4,513 3,633 24.2 % 24.2 % - 841 698 20.6 % 22.0 % -1.4 % 3,194 2,717 17.6 % 20.9 % -3.3 % 2,062 1,669 23.6 % 24.2 % -0.6 % 7,707 6,350 21.4 % 22.8 % -1.4 % 681 667 2.1 % 2.1 % - 2,738 2,458 11.4 % 11.4 % - 640 572 11.7 % 13.3 % -1.6 % 2,529 2,230 13.4 % 17.0 % -3.6 % 1,321 1,239 6.6 % 7.3 % -0.7 % 5,267 4,688 12.3 % 14.0 % -1.7 % 308 276 11.3 % 11.3 % - 1,213 1,066 13.7 % 13.7 % - 77 64 19.8 % 21.1 % -1.3 % 284 240 18.2 % 20.3 % -2.1 % 384 340 12.9 % 13.2 % -0.3 % 1,496 1,306 14.5 % 14.9 % -0.4 % 202 - - 442 - - 56 - - 122 - - 258 - - 564 - - 31 28 11.1 % 11.1 % - 120 109 10.7 % 10.7 % - 68 61 12.1 % 12.3 % -0.2 % 260 247 5.3 % 7.3 % -2.0 % 99 89 11.8 % 12.0 % -0.2 % 380 356 6.9 % 8.4 % -1.5 % 1,460 1,425 2.4 % 2.4 % - 5,689 5,525 3.0 % 3.0 % - 856 843 1.6 % 2.5 % -0.9 % 3,470 3,417 1.5 % 3.0 % -1.5 % 2,315 2,268 2.1 % 2.5 % -0.4 % 9,158 8,942 2.4 % 3.0 % -0.6 % 272 266 2.5 % 2.5 % - 1,057 996 6.2 % 6.2 % - 146 132 10.6 % 11.7 % -1.1 % 581 564 3.0 % 4.6 % -1.6 % 418 398 5.2 % 5.6 % -0.4 % 1,638 1,560 5.0 % 5.6 % -0.6 % 238 242 -1.5 % -1.5 % - 922 896 2.9 % 2.9 % - 160 144 10.7 % 11.3 % -0.6 % 623 559 11.3 % 12.4 % -1.1 % 398 387 3.1 % 3.3 % -0.2 % 1,545 1,456 6.1 % 6.5 % -0.4 % 514 487 5.5 % 5.5 % - 2,013 1,949 3.3 % 3.3 % - 250 255 -1.9 % -0.5 % -1.4 % 1,036 1,030 0.6 % 2.1 % -1.5 % 764 741 3.0 % 3.5 % -0.5 % 3,049 2,979 2.3 % 2.9 % -0.6 % 434 430 1.1 % 1.1 % - 1,696 1,684 0.7 % 0.7 % - 300 311 -3.6 % -2.9 % -0.7 % 1,230 1,263 -2.6 % -1.2 % -1.4 % 735 742 -0.9 % -0.6 % -0.3 % 2,926 2,947 -0.7 % -0.1 % -0.6 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) FOURTH QUARTER TWELVE MONTHS % Change % Change 2024 2023 Reported Operational (1) Currency 2024 2023 Reported Operational (1) Currency 1,038 1,047 -0.9 % -0.9 % - 4,003 4,031 -0.7 % -0.7 % - 1,469 1,484 -1.0 % 1.4 % -2.4 % 5,842 6,006 -2.7 % 0.6 % -3.3 % 2,507 2,530 -0.9 % 0.4 % -1.3 % 9,845 10,037 -1.9 % 0.1 % -2.0 % 478 468 2.0 % 2.0 % - 1,838 1,833 0.2 % 0.2 % - 673 698 -3.6 % -1.6 % -2.0 % 2,650 2,837 -6.6 % -3.5 % -3.1 % 1,151 1,167 -1.4 % -0.1 % -1.3 % 4,488 4,671 -3.9 % -2.0 % -1.9 % 560 579 -3.1 % -3.1 % - 2,165 2,198 -1.5 % -1.5 % - 795 785 1.4 % 4.0 % -2.6 % 3,192 3,168 0.8 % 4.3 % -3.5 % 1,357 1,364 -0.5 % 1.0 % -1.5 % 5,358 5,366 -0.2 % 2.0 % -2.2 % 509 487 4.5 % 4.5 % - 2,128 2,086 2.0 % 2.0 % - 794 721 10.2 % 12.2 % -2.0 % 3,018 2,986 1.1 % 3.7 % -2.6 % 1,303 1,208 7.9 % 9.1 % -1.2 % 5,146 5,072 1.5 % 3.0 % -1.5 % 396 374 6.0 % 6.0 % - 1,684 1,626 3.6 % 3.6 % - 541 508 6.4 % 8.5 % -2.1 % 2,049 2,076 -1.3 % 1.8 % -3.1 % 937 882 6.3 % 7.4 % -1.1 % 3,733 3,702 0.8 % 2.6 % -1.8 % 113 114 -0.4 % -0.4 % - 444 460 -3.4 % -3.4 % - 252 212 19.3 % 21.1 % -1.8 % 969 910 6.5 % 8.2 % -1.7 % 365 326 12.4 % 13.6 % -1.2 % 1,413 1,370 3.2 % 4.3 % -1.1 % 4,227 3,930 7.6 % 7.6 % - 16,332 15,275 6.9 % 6.9 % - 3,961 3,743 5.8 % 7.6 % -1.8 % 15,525 15,125 2.6 % 5.4 % -2.8 % $ 8,188 $ 7,673 6.7 % 7.6 % -0.9 % $ 31,857 30,400 4.8 % 6.2 % -1.4 % FOURTH QUARTER TWELVE MONTHS Percent Change Percent Change 2024 2023 Total Operations Currency 2024 2023 Total Operations Currency $ 8,977 8,079 11.1 11.1 - $ 33,970 31,169 9.0 9.0 - 5,355 5,643 (5.1 ) (1.0 ) (4.1 ) 22,994 23,590 (2.5 ) 1.3 (3.8 ) 14,332 13,722 4.4 6.1 (1.7 ) 56,964 54,759 4.0 5.7 (1.7 ) - - - - - - - - - - - 44 198 1,117 (82.4 ) (82.4 ) 0.0 - 44 198 1,117 (82.4 ) (82.4 ) 0.0 8,977 8,079 11.1 11.1 - 33,970 31,169 9.0 9.0 - 5,355 5,599 (4.4 ) (0.3 ) (4.1 ) 22,796 22,473 1.4 5.5 (4.1 ) 14,332 13,678 4.8 6.5 (1.7 ) 56,766 53,642 5.8 7.5 (1.7 ) 13,204 12,009 10.0 10.0 - 50,302 46,444 8.3 8.3 - 9,316 9,386 (0.7 ) 2.5 (3.2 ) 38,519 38,715 (0.5 ) 2.9 (3.4 ) 22,520 21,395 5.3 6.7 (1.4 ) 88,821 85,159 4.3 5.9 (1.6 ) - - - - - - - - - - - 44 * * * 198 1,117 (82.4 ) (82.4 ) 0.0 - 44 * * * 198 1,117 (82.4 ) (82.4 ) 0.0 13,204 12,009 10.0 10.0 - 50,302 46,444 8.3 8.3 - 9,316 9,342 (0.3 ) 2.9 (3.2 ) 38,321 37,598 1.9 5.5 (3.6 ) $ 22,520 21,351 5.5 6.9 (1.4 ) $ 88,623 84,042 5.5 7.0 (1.5 ) $ 4,921 4,962 (0.8 ) (0.2 ) (0.6 ) $ 20,212 20,410 (1.0 ) (0.6 ) (0.4 ) - 44 * * * 198 1,117 (82.4 ) (82.4 ) 0.0 $ 4,921 4,918 0.1 0.7 (0.6 ) $ 20,014 19,293 3.7 4.1 (0.4 ) Innovative Medicine MedTech Unallocated Worldwide Total 2024 2023 2024 2023 2024 2023 2024 2023 4,009 4,238 72 404 (194 ) 184 3,887 4,826 28.0 % 30.9 % 0.9 % 5.3 % -0.9 % 0.9 % 17.3 % 22.6 % 685 747 486 401 - - 1,171 1,148 17 - - 58 - - 17 58 (41 ) 17 (29 ) 149 54 - (16 ) 166 (50 ) (112 ) (18 ) (59 ) - (264 ) (68 ) (435 ) 2 55 60 84 - - 62 139 12 175 268 62 18 - 298 237 - - 47 88 - - 47 88 23 10 - - - - 23 10 4,657 5,130 886 1,187 (122 ) (80 ) 5,421 6,237 32.5 % 37.4 % 10.8 % 15.5 % -0.5 % -0.4 % 24.1 % 29.2 % 3,698 3,357 1,600 1,123 5,298 4,480 25.8 % 24.5 % 19.5 % 14.6 % 23.5 % 20.9 % 390 390 540 540 540 390 540 390 Innovative Medicine MedTech Unallocated Worldwide Total 2024 2023 2024 2023 2024 2023 2024 2023 18,919 18,246 3,740 4,669 (5,972 ) (7,853 ) 16,687 15,062 33.2 % 33.3 % 11.7 % 15.4 % -6.7 % -9.2 % 18.8 % 17.7 % 2,772 2,983 1,754 1,549 - - 4,526 4,532 211 206 - 107 - - 211 313 358 (108 ) (14 ) 190 5,106 7,070 5,450 7,152 (76 ) 362 30 (102 ) 352 381 306 641 102 479 167 319 - - 269 798 66 175 1,015 164 145 - 1,226 339 - - 204 311 - - 204 311 100 663 - - - - 100 663 22,452 23,006 6,896 7,207 (369 ) (402 ) 28,979 29,811 39.4 % 42.0 % 21.6 % 23.7 % -0.4 % -0.5 % 32.6 % 35.0 % 13,529 11,963 3,703 3,122 17,232 15,085 23.8 % 21.8 % 11.6 % 10.3 % 19.4 % 17.7 % 390 390 1,250 1,250 540 540 1,250 540 390 1,790 390 $ 7,128 (1,162 ) (20 ) (153 ) (18 ) - - 5,775 6,453 (4 ) 6,449 5,298 - (25 ) (6 ) 5,267 (161 ) (9 ) 16 - (145 ) 68 (17 ) (248 ) 17 (17 ) - - 42 (42 ) - 456 171 (158 ) 4 3 80 (34 ) 9 5 (61 ) 475 3,431 1,000 142 13 59 218 (34 ) 38 18 61 4,946 $ 6,798 (1,131 ) (83 ) (42 ) (12 ) - 5,530 5,810 (8 ) 5,802 4,480 (16 ) (38 ) (1 ) 4,425 (421 ) (17 ) (166 ) - (221 ) 435 3 (387 ) 58 (58 ) - 56 (56 ) - 694 175 (134 ) 13 16 30 (191 ) 16 - 56 675 4,132 973 300 45 123 207 (244 ) 72 10 (56 ) 5,562 $ 27,471 (4,517 ) (35 ) (359 ) (84 ) (8 ) 22,468 22,869 (16 ) - 22,853 17,232 (69 ) (104 ) (25 ) 17,034 4,694 (9 ) (5,450 ) - (798 ) (306 ) (67 ) (1,936 ) 211 (211 ) - - - - - 234 (234 ) - 2,621 644 1,066 47 45 302 (29 ) 38 22 (19 ) 4,737 14,066 3,882 4,384 164 224 924 335 166 78 19 24,242 $ 26,553 (4,511 ) (309 ) (133 ) (189 ) 21,411 21,512 (29 ) 21,483 15,085 (32 ) (149 ) (99 ) 14,805 6,634 (21 ) (7,152 ) - (307 ) (641 ) (375 ) (1,862 ) 313 (313 ) - - 489 (489 ) - 1,736 707 1,505 70 157 52 (9 ) 57 155 (28 ) 4,402 13,326 3,825 5,647 243 641 287 650 254 508 28 25,409 Media contact: media-relations@its.jnj.com Investor contact: investor-relations@its.jnj.com

A change in the initiation of donanemab dosing, shifting one vial of donanemab from the first infusion to the third infusion, lowered ARIA-E to 14% compared to 24% in patients receiving the standard dosing regimen used in the pivotal Phase 3 clinical trialReduction of amyloid plaque and P-tau217 on this modified titration was comparable to patients receiving the standard dosing regimenLilly intends to submit this data to global regulators for a potential label update for Kisunla (donanemab-azbt) INDIANAPOLIS, Oct. 29, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced positive results from the TRAILBLAZER-ALZ 6 Phase 3b study, showing a reduction in amyloid-related imaging abnormalities with edema/effusion (ARIA-E) at the 24-week primary endpoint for people receiving a slightly modified titration of donanemab in adults with early symptomatic Alzheimer's disease (AD).1 Donanemab is approved under the brand name Kisunla™ in the United States, Japan, Great Britain and other countries. These data were presented at the 17th Clinical Trials on Alzheimer's Disease (CTAD) Conference in Madrid, Spain. Continue Reading Modified Titration Differs from Standard Dosing by Shifting a Single Vial. TRAILBLAZER-ALZ 6 is a multicenter, randomized, double-blind, Phase 3b study to investigate the impact of different dosing regimens of donanemab on the rates of ARIA-E and amyloid clearance in adults with early symptomatic AD, which includes mild cognitive impairment (MCI) and the mild dementia stage of disease. "Lilly is committed to continuing research to optimize therapy for patients with Alzheimer's disease. We are confident in the benefits of Kisunla's currently approved dosing regimen and are excited that these results reveal a path to potentially improving on Kisunla's profile by reducing the risk of ARIA-E," said Mark Mintun, M.D., group vice president Neuroscience Research & Development, Eli Lilly and Company, and president of Avid Radiopharmaceuticals. "The modified titration could offer continued convenience of once-monthly dosing and limited duration treatment while also reducing ARIA-E and maintaining similar amyloid plaque removal." The study included four treatment arms. One arm was the once-monthly standard dosing regimen used in the Phase 3 TRAILBLAZER-ALZ 2 trial. The other three arms used alternative dosing regimens with the same total drug administered. The results at 24 weeks showed the once-monthly modified titration described below met the predefined study success criteria and demonstrated the greatest reduction of ARIA-E compared to the other dosing arms.1 Patients on the standard dosing regimen received two vials (700 mg) of donanemab for the first three infusions, then four vials (1400 mg) thereafter. Patients on the modified titration received 1 vial (350 mg) for the first infusion, two vials (700 mg) for the second infusion, three vials (1,050 mg) for the third infusion, and four vials (1400 mg) per infusion thereafter. The only difference between the modified titration and the standard dosing regimen is the shift of one vial from the first infusion to the third infusion. Pharmacokinetic (PK) analysis demonstrated equivalent cumulative exposure between modified titration and standard dosing regimen. The primary endpoint of the study was the proportion of participants with any occurrence of ARIA-E by week 24, and the results showed the incidence of ARIA-E was 14% in patients receiving the modified titration compared with 24% for those receiving the standard dosing regimen, a 41% lower relative risk. The largest ARIA-E reduction with the modified titration was seen in apolipoprotein E (APOE4) homozygotes, carriers of a known genetic risk factor for developing Alzheimer's disease. In these patients, 19% had ARIA-E on the modified titration as compared to 57% on the standard dosing regimen, resulting in a 67% lower relative risk. Patients on the modified titration of donanemab saw reduction of amyloid plaque and P-tau217 comparable to patients receiving the standard dosing regimen. As observed using amyloid PET at 24 weeks, amyloid plaque levels in patients on the modified titration of donanemab in TRAILBLAZER-ALZ 6 were reduced on average 67% from baseline compared to 69% for patients on the standard dosing regimen. The pathological relevance of beta-amyloid plaques in the development of Alzheimer's disease and the importance of removing plaques to slow disease progression has been well-established: both the Phase 3 TRAILBLAZER-ALZ 2 study and the Phase 2 TRAILBLAZER-ALZ study demonstrated that the removal of amyloid plaque from the brain can lead to statistically significant slowing of cognitive and functional decline in patients with early symptomatic Alzheimer's disease.2, 3 The TRAILBLAZER-ALZ 6 study is ongoing with data investigating the potential reduction of ARIA-E in adults with early symptomatic AD at week 52 expected early next year. Aside from the improvement in ARIA-E rates, safety profiles were comparable across arms, and no new safety signals were identified. The frequency of infusion-related reactions in the modified titration arm was similar to the standard dosing arm. One participant in the modified titration arm with an ongoing ARIA-E presented stroke-like symptoms, and after receiving tissue-type plasminogen activator treatment (tPA), subsequently died due to cerebral intraparenchymal hemorrhage. As noted in the FDA labeling for this class of medicines, caution should be exercised when considering the administration of agents such as thrombolytics (e.g. tPA) to patients already being treated with amyloid targeting therapies. Lilly is discussing the results of this study with global regulators, with the intent to submit for a potential label update for Kisunla. About TRAILBLAZER-ALZ 6 Study and the TRAILBLAZER-ALZ program TRAILBLAZER-ALZ 6 (NCT05738486) is a Phase 3b, multicenter, randomized, double-blind study to investigate different dosing regimens and their effect on ARIA-E in adults with early symptomatic Alzheimer's disease. The trial enrolled 843 participants ages 60-85 selected based on cognitive assessments in conjunction with amyloid plaque imaging by PET scan. Lilly continues to study donanemab in multiple clinical trials, including TRAILBLAZER-ALZ 3, focused on reducing risk of progression to symptomatic AD in participants with preclinical AD; and TRAILBLAZER-ALZ 5, a registration trial for early symptomatic AD currently enrolling in China, Korea, Taiwan, and other geographies. About Kisunla™ (donanemab) Kisunla™ (donanemab-azbt) (pronounced kih-SUHN-lah) is an amyloid-targeting treatment for people with mild cognitive impairment (MCI) as well as people with mild dementia stage of early symptomatic Alzheimer's disease, with confirmed amyloid pathology. Kisunla can cause serious side effects, including amyloid-related imaging abnormalities, or ARIA, and infusion-related reactions. Kisunla is a prescription medicine administered intravenously every four weeks, 700 mg for the first three doses and 1400 mg thereafter. INDICATION AND SAFETY SUMMARY WITH WARNINGS Kisunla™ (donanemab-azbt), pronounced kih-SUHN-lah, is used to treat adults with early symptomatic Alzheimer's disease (AD), which includes mild cognitive impairment (MCI) or mild dementia stage of disease. Warnings - Kisunla can cause Amyloid-Related Imaging Abnormalities or "ARIA." This is a common side effect that does not usually cause any symptoms, but serious symptoms can occur. ARIA can be fatal. ARIA is most commonly seen as temporary swelling in an area or areas of the brain that usually goes away over time. Some people may also have spots of bleeding on the surface of or in the brain and infrequently, larger areas of bleeding in the brain can occur. Although most people do not have symptoms, some people have headaches, dizziness, nausea, difficulty walking, confusion, vision changes and seizures. Some people have a genetic risk factor (homozygous apolipoprotein E ε4 gene carriers) that may cause an increased risk for ARIA. Talk to your healthcare provider about testing to see if you have this risk factor. You may be at higher risk of developing bleeding in the brain if you take medicines to reduce blood clots from forming (antithrombotic medicines) while receiving Kisunla. Talk to your healthcare provider to see if you are on any medicines that increase this risk. Your healthcare provider will do magnetic resonance imaging (MRI) brain scans before and during your treatment with Kisunla to check you for ARIA. You should carry information that you are receiving Kisunla, which can cause ARIA, and that ARIA symptoms can look like stroke symptoms. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the symptoms listed above. There are registries that collect information on treatments for Alzheimer's disease. Your healthcare provider can help you become enrolled in these registries. Warnings - Kisunla can cause serious allergic and infusion-related reactions. Do not receive Kisunla if you have serious allergic reactions to donanemab-azbt or any of the ingredients in Kisunla. Symptoms may include swelling of the face, lips, mouth, or eyelids, problems breathing, hives, chills, irritation of skin, nausea, vomiting, sweating, headache, or chest pain. You will be monitored for at least 30 minutes after you receive Kisunla for any reaction. Tell your healthcare provider right away if you have these symptoms or any reaction during or after a Kisunla infusion. Other common side effects Headache Tell your healthcare provider right away if you have any side effects. These are not all of the possible side effects of Kisunla. You can report side effects at 1-800-FDA-1088 or . Before you receive Kisunla, tell your healthcare provider: About all medicines you take, including prescription and over-the-counter medicines, as well as vitamins and herbal supplements. Especially tell your healthcare provider if you have medicines to reduce blood clots from forming (antithrombotic medicines, including aspirin). About all of your medical conditions including if you are pregnant, breastfeeding, or plan to become pregnant or breastfeed. Kisunla has not been studied in people who were pregnant or breastfeeding. It is not known if Kisunla could harm your unborn or breastfeeding baby. How to receive Kisunla Kisunla is a prescription medicine given through an intravenous (IV) infusion using a needle inserted into a vein in your arm. Kisunla is given once every 4 weeks. Each infusion will last about 30 minutes. Learn more For more information about Kisunla, call 1-800-LillyRx (1-800-545-5979) or go to kisunla.lilly.com. This summary provides basic information about Kisunla. It does not include all information known about this medicine. Read the information given to you about Kisunla. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Kisunla. Your healthcare provider is the best person to help you decide if Kisunla is right for you. Please see full Prescribing Information including boxed warning for ARIA and Medication Guide for Kisunla. About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn. P-LLY © Lilly USA, LLC 2024. ALL RIGHTS RESERVED. Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Kisunla (donanemab-azbt) as a treatment for people with early symptomatic Alzheimer's disease, Kisunla dosing regimens and the prevalence of ARIA-E, and future readouts, presentations, and other milestones relating to Kisunla and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study findings to date, that Kisunla will receive additional regulatory approvals or that Kisunla will be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. References Eli Lilly. A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6). ClinicalTrials.gov identifier: NCT05738486. Updated July 24, 2024. Accessed September 30, 2024. . Kisunla (donanemab-azbt). Prescribing Information. Lilly USA, LLC. Data on File. Lilly USA, LLC. DOF-DN-US-0029. SOURCE Eli Lilly and Company WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

POTOMAC, Md.--( BUSINESS WIRE )--IGC Pharma, Inc. (NYSE American: IGC) ("IGC Pharma" or the "Company") announced today that the Company is advancing its proprietary formulation, IGC-AD1, toward clinical trials as a potential anti-amyloid disease-modifying treatment for Alzheimer's disease. Following the FDA's 2023 approval of two groundbreaking anti-amyloid drugs, Donanemab (Eli Lilly) and Lecanemab (Eisai and Biogen), IGC Pharma is poised to make a significant contribution to this critical field with IGC-AD1. The recognition of amyloid-targeted therapies in slowing Alzheimer's progression and improving cognitive function underscores the growing demand for innovative treatments. While the recent drug approvals have been a significant milestone in enhancing disease treatment, there is still an increasing demand for safe and effective treatments. IGC-AD1, an orally administered medication with a strong safety profile, potentially positions IGC Pharma favorably in this market landscape. IGC-AD1, with its patent protection, represents a promising advancement in Alzheimer's treatment. The APIs in IGC-AD1 have been shown to target amyloid plaques in Alzheimer's cell lines through two mechanisms: a) inhibiting amyloid protein production and b) preventing its aggregation. Preliminary data from Alzheimer's cell lines suggest that IGC-AD1 may reduce plaque aggregation by approximately 20% and decrease its production by up to 40% without affecting the production of Amyloid Precursor Protein ("APP"), which is essential for cell growth and survival. Ram Mukunda, CEO of IGC Pharma, stated, "As we continue our ongoing Phase 2 clinical trials for treating agitation in Alzheimer's dementia with IGC-AD1, we're excited to advance our research into its potential as an anti-amyloid disease-modifying treatment. Evidence from cell lines suggests that IGC-AD1 may reduce amyloid levels while preserving APP production, a critical factor for brain health. With Phase 1 and Phase 2 interim safety and tolerability data, IGC-AD1 stands out as a differentiated drug candidate. The initiation of disease-modifying investigational trials, expected in early 2025, will open a significant market opportunity for IGC Pharma. "By initiating new trials focused on IGC-AD1's ability to modify amyloid plaque progression, we hope to position IGC Pharma to deliver a breakthrough treatment in Alzheimer's disease, driving substantial value for our shareholders." About IGC Pharma (dba IGC): IGC Pharma is an AI-powered, clinical-stage biotechnology company focused on developing innovative treatments for Alzheimer's disease and transforming patient care with fast-acting safe, and effective solutions. Our portfolio includes the TGR family, including TGR-63, which targets amyloid plaques, a hallmark of Alzheimer's. The IGC-C and IGC-M platforms are advancing in preclinical studies, focusing on metabolic disorders, tau proteins, early plaque formation, and multiple disease hallmarks. Our lead therapeutic candidate, IGC-AD1, is a cannabinoid-based treatment currently in a Phase 2 trial for agitation in dementia associated with Alzheimer's ( clinicaltrials.gov , NCT05543681). Interim data for IGC-AD1 demonstrated that it has the potential to transform patient care by offering faster-acting and more effective relief compared to traditional medications. Additionally, our AI models are designed to predict potential biomarkers for the early detection of Alzheimer's, optimize clinical trials, and predict receptor affinity, among others. With 28 patent filings and a commitment to innovation, IGC Pharma is dedicated to advancing pharmaceutical treatments and improving the lives of those affected by Alzheimer's and related conditions. Forward-looking Statements This press release contains forward-looking statements. These forward-looking statements are based largely on IGC Pharma's expectations and are subject to several risks and uncertainties, certain of which are beyond IGC Pharma's control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, the Company's failure or inability to commercialize one or more of the Company's products or technologies, including the products or formulations described in this release, or failure to obtain regulatory approval for the products or formulations, where required, or government regulations affecting AI or the AI algorithms not working as intended or producing accurate predictions; general economic conditions that are less favorable than expected; the FDA's general position regarding cannabis- and hemp-based products; and other factors, many of which are discussed in IGC Pharma's U.S. Securities and Exchange Commission ("SEC") filings. IGC incorporates by reference its Annual Report on Form 10-K filed with the SEC on June 24, 2024, and on Form 10-Q filed with the SEC on August 7, 2024, as if fully incorporated and restated herein. Considering these risks and uncertainties, there can be no assurance that the forward-looking information contained in this release will occur.