(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
Exhibit No. | Description of Exhibit | ||||
104 | The cover page from this Current Report on Form 8-K, formatted in Inline XBRL. |
Johnson & Johnson | ||||||||||||||
(Registrant) | ||||||||||||||
Date: | October 13, 2020 | By: | /s/ Robert J. Decker, Jr. | |||||||||||
Robert J. Decker, Jr. Controller (Principal Accounting Officer) |
Regulatory Approvals | THERMOCOOL SMARTTOUCH – Biosense Webster Receives FDA Approval for SF Ablation Catheter for the Treatment of Persistent Atrial Fibrillation¹ | (press release) | ||||||
SIMPONI ARIA (golimumab) – Approved by the U.S. Food and Drug Administration for Active Polyarticular Juvenile Idiopathic Arthritis and Extension of Its Active Psoriatic Arthritis Indication in Patients 2 Years of Age and Older | (press release) | |||||||
SPRAVATO (esketamine) – Janssen Announces U.S. FDA Approval of CIII Nasal Spray to Treat Depressive Symptoms in Adults with Major Depressive Disorder with Acute Suicidal Ideation or Behavior | (press release) | |||||||
DARZALEX (daratumumab) – U.S. FDA Approves New DARZALEX-Based Combination Regimen for Patients with Relapsed/Refractory Multiple Myeloma | (press release) | |||||||
STELARA (ustekinumab) – U.S. Food and Drug Administration Approves Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis | (press release) | |||||||
Regulatory Submissions | UPTRAVI (selexipag) – Janssen Submits New Drug Application (NDA) to U.S. FDA for Injection for Intravenous Use to Treat Pulmonary Arterial Hypertension (PAH) | (press release) | ||||||
DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) – Janssen Submits Application Seeking U.S. FDA Approval for the Treatment of Patients with Light Chain (AL) Amyloidosis | (press release) | |||||||
Other | Johnson & Johnson Announces European Commission Approval of Agreement to Supply 200 Million Doses of Janssen's COVID-19 Vaccine Candidate ¹ | (press release) | ||||||
Johnson & Johnson Completes Acquisition of Momenta Pharmaceuticals, Inc.¹ | (press release) | |||||||
Johnson & Johnson Initiates Pivotal Global Phase 3 Clinical Trial of Janssen's COVID-19 Vaccine Candidate | (press release) | |||||||
CERENOVUS Launches New Suite of Technologies to Advance Stroke Treatment | (press release) | |||||||
Johnson & Johnson Announces that Janssen’s COVID-19 Investigational Vaccine Candidate Prevents Severe Clinical Disease in Pre-clinical Studies | (press release) | |||||||
Janssen to Discontinue Pimodivir Influenza Development Program | (press release) | |||||||
Johnson & Johnson Announces Agreement with U.S. Government for 100 Million Doses of Investigational COVID-19 Vaccine | (press release) | |||||||
U.S. FDA Grants Ethicon Breakthrough Device Designation for Monarch-enabled NeuWave Microwave Ablation Technology | (press release) |
October 2020 | July 2020 |
Adjusted Operational Sales1,2 Change vs. Prior Year | 0.5% - 1.5% | (0.8%) - 1.0% | ||||||
Operational Sales2 Change vs. Prior Year | $82.0 to $82.8 0.0% - 1.0% | $81.0 to $82.5 (1.3%) - 0.5% | ||||||
Estimated Reported Sales3 Change vs. Prior Year | $81.2 to $82.0 (1.0%) - 0.0% | $79.9 to $81.4 (2.6%) - (0.8%) | ||||||
Adjusted Operational EPS (Diluted)2,4 Change vs. Prior Year | $7.95 to $8.05 (8.4%) - (7.3%) | $7.85 to $8.05 (9.6%) - (7.3%) | ||||||
Adjusted EPS (Diluted)3,4 Change vs. Prior Year | $7.95 to $8.05 (8.4%) - (7.3%) | $7.75 to $7.95 (10.7%) - (8.4%) |
Johnson & Johnson and Subsidiaries | |||||||||||||||||||||||||||||
Supplementary Sales Data | |||||||||||||||||||||||||||||
(Unaudited; Dollars in Millions) | THIRD QUARTER | ||||||||||||||||||||||||||||
Percent Change | |||||||||||||||||||||||||||||
2020 | 2019 | Total | Operations | Currency | |||||||||||||||||||||||||
Sales to customers by | |||||||||||||||||||||||||||||
geographic area | |||||||||||||||||||||||||||||
U.S. | $11,086 | 10,791 | 2.7 | % | 2.7 | - | |||||||||||||||||||||||
Europe | 4,819 | 4,461 | 8.0 | 4.6 | 3.4 | ||||||||||||||||||||||||
Western Hemisphere excluding U.S. | 1,296 | 1,488 | (12.9) | (1.2) | (11.7) | ||||||||||||||||||||||||
Asia-Pacific, Africa | 3,881 | 3,989 | (2.7) | (3.2) | 0.5 | ||||||||||||||||||||||||
International | 9,996 | 9,938 | 0.6 | 0.6 | 0.0 | ||||||||||||||||||||||||
Worldwide | $21,082 | 20,729 | 1.7 | % | 1.7 | 0.0 | |||||||||||||||||||||||
Note: Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely. | |||||||||||||||||||||||||||||
Johnson & Johnson and Subsidiaries | |||||||||||||||||||||||||||||
Supplementary Sales Data | |||||||||||||||||||||||||||||
(Unaudited; Dollars in Millions) | NINE MONTHS | ||||||||||||||||||||||||||||
Percent Change | |||||||||||||||||||||||||||||
2020 | 2019 | Total | Operations | Currency | |||||||||||||||||||||||||
Sales to customers by | |||||||||||||||||||||||||||||
geographic area | |||||||||||||||||||||||||||||
U.S. | $31,324 | 31,323 | 0.0 | % | 0.0 | - | |||||||||||||||||||||||
Europe | 13,709 | 13,803 | (0.7) | 0.1 | (0.8) | ||||||||||||||||||||||||
Western Hemisphere excluding U.S. | 3,931 | 4,446 | (11.6) | (0.4) | (11.2) | ||||||||||||||||||||||||
Asia-Pacific, Africa | 11,145 | 11,740 | (5.1) | (4.3) | (0.8) | ||||||||||||||||||||||||
International | 28,785 | 29,989 | (4.0) | (1.7) | (2.3) | ||||||||||||||||||||||||
Worldwide | $60,109 | 61,312 | (2.0) | % | (0.8) | (1.2) | |||||||||||||||||||||||
Note: Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely. | |||||||||||||||||||||||||||||
Johnson & Johnson and Subsidiaries | |||||||||||||||||||||||||||||
Supplementary Sales Data | |||||||||||||||||||||||||||||
(Unaudited; Dollars in Millions) | THIRD QUARTER | ||||||||||||||||||||||||||||
Percent Change | |||||||||||||||||||||||||||||
2020 | 2019 | Total | Operations | Currency | |||||||||||||||||||||||||
Sales to customers by | |||||||||||||||||||||||||||||
segment of business | |||||||||||||||||||||||||||||
Consumer Health | |||||||||||||||||||||||||||||
U.S. | $ | 1,556 | 1,394 | 11.6 | % | 11.6 | — | ||||||||||||||||||||||
International | 1,958 | 2,075 | (5.6) | (2.7) | (2.9) | ||||||||||||||||||||||||
3,514 | 3,469 | 1.3 | 3.0 | (1.7) | |||||||||||||||||||||||||
Pharmaceutical | |||||||||||||||||||||||||||||
U.S. | 6,438 | 6,340 | 1.5 | 1.5 | — | ||||||||||||||||||||||||
International | 4,980 | 4,537 | 9.7 | 8.8 | 0.9 | ||||||||||||||||||||||||
11,418 | 10,877 | 5.0 | 4.6 | 0.4 | |||||||||||||||||||||||||
Medical Devices | |||||||||||||||||||||||||||||
U.S. | 3,092 | 3,057 | 1.2 | 1.2 | — | ||||||||||||||||||||||||
International | 3,058 | 3,326 | (8.1) | (8.5) | 0.4 | ||||||||||||||||||||||||
6,150 | 6,383 | (3.6) | (3.9) | 0.3 | |||||||||||||||||||||||||
U.S. | 11,086 | 10,791 | 2.7 | 2.7 | — | ||||||||||||||||||||||||
International | 9,996 | 9,938 | 0.6 | 0.6 | 0.0 | ||||||||||||||||||||||||
Worldwide | $ | 21,082 | 20,729 | 1.7 | 1.7 | 0.0 | |||||||||||||||||||||||
Note: Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely. | |||||||||||||||||||||||||||||
Johnson & Johnson and Subsidiaries | |||||||||||||||||||||||||||||
Supplementary Sales Data | |||||||||||||||||||||||||||||
(Unaudited; Dollars in Millions) | NINE MONTHS | ||||||||||||||||||||||||||||
Percent Change | |||||||||||||||||||||||||||||
2020 | 2019 | Total | Operations | Currency | |||||||||||||||||||||||||
Sales to customers by | |||||||||||||||||||||||||||||
segment of business | |||||||||||||||||||||||||||||
Consumer Health | |||||||||||||||||||||||||||||
U.S. | $ | 4,853 | 4,369 | 11.1 | % | 11.1 | - | ||||||||||||||||||||||
International | 5,582 | 5,962 | (6.4) | (2.2) | (4.2) | ||||||||||||||||||||||||
10,435 | 10,331 | 1.0 | 3.4 | (2.4) | |||||||||||||||||||||||||
Pharmaceutical | |||||||||||||||||||||||||||||
U.S. | 18,619 | 17,705 | 5.2 | 5.2 | - | ||||||||||||||||||||||||
International | 14,685 | 13,945 | 5.3 | 7.4 | (2.1) | ||||||||||||||||||||||||
33,304 | 31,650 | 5.2 | 6.1 | (0.9) | |||||||||||||||||||||||||
Medical Devices | |||||||||||||||||||||||||||||
U.S. | 7,852 | 9,249 | (15.1) | (15.1) | - | ||||||||||||||||||||||||
International | 8,518 | 10,082 | (15.5) | (14.1) | (1.4) | ||||||||||||||||||||||||
16,370 | 19,331 | (15.3) | (14.6) | (0.7) | |||||||||||||||||||||||||
U.S. | 31,324 | 31,323 | 0.0 | 0.0 | - | ||||||||||||||||||||||||
International | 28,785 | 29,989 | (4.0) | (1.7) | (2.3) | ||||||||||||||||||||||||
Worldwide | $ | 60,109 | 61,312 | (2.0) | (0.8) | (1.2) | |||||||||||||||||||||||
Note: Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely. | |||||||||||||||||||||||||||||
Johnson & Johnson and Subsidiaries | |||||||||||||||||||||||||||||
Condensed Consolidated Statement of Earnings | |||||||||||||||||||||||||||||
(Unaudited; in Millions Except Per Share Figures) | THIRD QUARTER | ||||||||||||||||||||||||||||
2020 | 2019 | Percent | |||||||||||||||||||||||||||
Percent | Percent | Increase | |||||||||||||||||||||||||||
Amount | to Sales | Amount | to Sales | (Decrease) | |||||||||||||||||||||||||
Sales to customers | $ | 21,082 | 100.0 | $ | 20,729 | 100.0 | 1.7 | ||||||||||||||||||||||
Cost of products sold | 6,972 | 33.1 | 6,867 | 33.1 | 1.5 | ||||||||||||||||||||||||
Gross Profit | 14,110 | 66.9 | 13,862 | 66.9 | 1.8 | ||||||||||||||||||||||||
Selling, marketing and administrative expenses | 5,431 | 25.8 | 5,374 | 26.0 | 1.1 | ||||||||||||||||||||||||
Research and development expense | 2,840 | 13.5 | 2,599 | 12.5 | 9.3 | ||||||||||||||||||||||||
In-process research and development | 138 | 0.6 | — | — | |||||||||||||||||||||||||
Interest (income) expense, net | 32 | 0.1 | (41) | (0.2) | |||||||||||||||||||||||||
Other (income) expense, net | 1,200 | 5.7 | 4,214 | 20.3 | |||||||||||||||||||||||||
Restructuring | 68 | 0.3 | 69 | 0.4 | |||||||||||||||||||||||||
Earnings before provision for taxes on income | 4,401 | 20.9 | 1,647 | 7.9 | 167.2 | ||||||||||||||||||||||||
Provision for/(Benefit from) taxes on income | 847 | 4.0 | (106) | (0.6) | |||||||||||||||||||||||||
Net earnings | $ | 3,554 | 16.9 | $ | 1,753 | 8.5 | 102.7 | ||||||||||||||||||||||
Net earnings per share (Diluted) | $ | 1.33 | $ | 0.66 | 101.5 | ||||||||||||||||||||||||
Average shares outstanding (Diluted) | 2,669.3 | 2,669.9 | |||||||||||||||||||||||||||
Effective tax rate | 19.2 | % | (6.4) | % | |||||||||||||||||||||||||
Adjusted earnings before provision for taxes and net earnings (1) (A) | |||||||||||||||||||||||||||||
Earnings before provision for taxes on income | $ | 7,246 | 34.4 | $ | 7,116 | 34.3 | 1.8 | ||||||||||||||||||||||
Net earnings | $ | 5,868 | 27.8 | $ | 5,672 | 27.4 | 3.5 | ||||||||||||||||||||||
Net earnings per share (Diluted) | $ | 2.20 | $ | 2.12 | 3.8 | ||||||||||||||||||||||||
Effective tax rate | 19.0 | % | 20.3 | % | |||||||||||||||||||||||||
(1) See Reconciliation of Non-GAAP Financial Measures. | |||||||||||||||||||||||||||||
(A) NON-GAAP FINANCIAL MEASURES "Adjusted earnings before provision for taxes on income," "adjusted net earnings," "adjusted net earnings per share (diluted)," and "adjusted effective tax rate" are non-GAAP financial measures and should not be considered replacements for GAAP results. The Company provides earnings before provision for taxes on income, net earnings, net earnings per share (diluted), and effective tax rate on an adjusted basis because management believes that these measures provide useful information to investors. Among other things, these measures may assist investors in evaluating the Company's results of operations period over period. In various periods, these measures may exclude such items as intangible asset amortization expense, significant costs associated with acquisitions, restructuring, litigation, and changes in applicable laws and regulations (including significant accounting or tax matters). Special items may be highly variable, difficult to predict, and of a size that sometimes has substantial impact on the Company's reported results of operations for a period. Management uses these measures internally for planning, forecasting and evaluating the performances of the Company's businesses, including allocating resources and evaluating results relative to employee performance compensation targets. Unlike earnings before provision for taxes on income, net earnings, net earnings per share (diluted), and effective tax rate prepared in accordance with GAAP, adjusted earnings before provision for taxes on income, adjusted net earnings, adjusted net earnings per share (diluted), and adjusted effective tax rate may not be comparable with the calculation of similar measures for other companies. The limitations of using these non-GAAP financial measures as performance measures are that they provide a view of the Company's results of operations without including all events during a period, such as intangible asset amortization expense, the effects of an acquisition, restructuring, litigation, and changes in applicable laws and regulations (including significant accounting or tax matters) and do not provide a comparable view of the Company's performance to other companies in the health care industry. Investors should consider non-GAAP financial measures in addition to, and not as replacements for, or superior to, measures of financial performance prepared in accordance with GAAP. |
Johnson & Johnson and Subsidiaries | |||||||||||||||||||||||||||||
Condensed Consolidated Statement of Earnings | |||||||||||||||||||||||||||||
(Unaudited; in Millions Except Per Share Figures) | NINE MONTHS | ||||||||||||||||||||||||||||
2020 | 2019 | Percent | |||||||||||||||||||||||||||
Percent | Percent | Increase | |||||||||||||||||||||||||||
Amount | to Sales | Amount | to Sales | (Decrease) | |||||||||||||||||||||||||
Sales to customers | $ | 60,109 | 100.0 | $ | 61,312 | 100.0 | (2.0) | ||||||||||||||||||||||
Cost of products sold | 20,613 | 34.3 | 20,422 | 33.3 | 0.9 | ||||||||||||||||||||||||
Gross Profit | 39,496 | 65.7 | 40,890 | 66.7 | (3.4) | ||||||||||||||||||||||||
Selling, marketing and administrative expenses | 15,627 | 26.0 | 16,139 | 26.3 | (3.2) | ||||||||||||||||||||||||
Research and development expense | 8,127 | 13.5 | 8,123 | 13.3 | 0.0 | ||||||||||||||||||||||||
In-process research and development | 144 | 0.3 | 890 | 1.4 | |||||||||||||||||||||||||
Interest (income) expense, net | 16 | 0.0 | (43) | (0.1) | |||||||||||||||||||||||||
Other (income) expense, net | 545 | 0.9 | 2,509 | 4.1 | |||||||||||||||||||||||||
Restructuring | 187 | 0.3 | 162 | 0.3 | |||||||||||||||||||||||||
Earnings before provision for taxes on income | 14,850 | 24.7 | 13,110 | 21.4 | 13.3 | ||||||||||||||||||||||||
Provision for taxes on income | 1,874 | 3.1 | 2,001 | 3.3 | (6.3) | ||||||||||||||||||||||||
Net earnings | $ | 12,976 | 21.6 | $ | 11,109 | 18.1 | 16.8 | ||||||||||||||||||||||
Net earnings per share (Diluted) | $ | 4.86 | $ | 4.13 | 17.7 | ||||||||||||||||||||||||
Average shares outstanding (Diluted) | 2,670.8 | 2,688.1 | |||||||||||||||||||||||||||
Effective tax rate | 12.6 | % | 15.3 | % | |||||||||||||||||||||||||
Adjusted earnings before provision for taxes and net earnings (1) (A) | |||||||||||||||||||||||||||||
Earnings before provision for taxes on income | $ | 19,827 | 33.0 | $ | 22,597 | 36.9 | (12.3) | ||||||||||||||||||||||
Net earnings | $ | 16,468 | 27.4 | $ | 18,283 | 29.8 | (9.9) | ||||||||||||||||||||||
Net earnings per share (Diluted) | $ | 6.17 | $ | 6.80 | (9.3) | ||||||||||||||||||||||||
Effective tax rate | 16.9 | % | 19.1 | % | |||||||||||||||||||||||||
(1) See Reconciliation of Non-GAAP Financial Measures. | |||||||||||||||||||||||||||||
(A) NON-GAAP FINANCIAL MEASURES "Adjusted earnings before provision for taxes on income," "adjusted net earnings," "adjusted net earnings per share (diluted)," and "adjusted effective tax rate" are non-GAAP financial measures and should not be considered replacements for GAAP results. The Company provides earnings before provision for taxes on income, net earnings, net earnings per share (diluted), and effective tax rate on an adjusted basis because management believes that these measures provide useful information to investors. Among other things, these measures may assist investors in evaluating the Company's results of operations period over period. In various periods, these measures may exclude such items as intangible asset amortization expense, significant costs associated with acquisitions, restructuring, litigation, and changes in applicable laws and regulations (including significant accounting or tax matters). Special items may be highly variable, difficult to predict, and of a size that sometimes has substantial impact on the Company's reported results of operations for a period. Management uses these measures internally for planning, forecasting and evaluating the performances of the Company's businesses, including allocating resources and evaluating results relative to employee performance compensation targets. Unlike earnings before provision for taxes on income, net earnings, net earnings per share (diluted), and effective tax rate prepared in accordance with GAAP, adjusted earnings before provision for taxes on income, adjusted net earnings, adjusted net earnings per share (diluted), and adjusted effective tax rate may not be comparable with the calculation of similar measures for other companies. The limitations of using these non-GAAP financial measures as performance measures are that they provide a view of the Company's results of operations without including all events during a period, such as intangible asset amortization expense, the effects of an acquisition, restructuring, litigation, and changes in applicable laws and regulations (including significant accounting or tax matters) and do not provide a comparable view of the Company's performance to other companies in the health care industry. Investors should consider non-GAAP financial measures in addition to, and not as replacements for, or superior to, measures of financial performance prepared in accordance with GAAP. |
Johnson & Johnson and Subsidiaries | ||||||||||||||
Reconciliation of Non-GAAP Financial Measures | ||||||||||||||
Third Quarter | ||||||||||||||
(Dollars in Millions Except Per Share Data) | 2020 | 2019 | ||||||||||||
Net Earnings, after tax- as reported | $3,554 | $1,753 | ||||||||||||
Pre-tax Adjustments | ||||||||||||||
Intangible Asset Amortization expense | 1,181 | 1,138 | ||||||||||||
Litigation expense, net | 1,477 | 4,000 | ||||||||||||
IPR&D | 138 | - | ||||||||||||
Restructuring related | 130 | 128 | ||||||||||||
Acquisition and Integration related ¹ | (154) | 107 | ||||||||||||
Unrealized (gains)/losses on securities | 32 | 89 | ||||||||||||
Medical Device Regulation 2 | 38 | - | ||||||||||||
Other | 3 | 7 | ||||||||||||
Tax Adjustments | ||||||||||||||
Tax impact on special item adjustments 3 | (482) | (1,159) | ||||||||||||
Tax legislation and related impacts | (49) | (391) | ||||||||||||
Adjusted Net Earnings, after tax | $5,868 | $5,672 | ||||||||||||
Average shares outstanding (Diluted) | 2,669.3 | 2,669.9 | ||||||||||||
Adjusted net earnings per share (Diluted) | $2.20 | $2.12 | ||||||||||||
Operational adjusted net earnings per share (Diluted) | $2.17 | |||||||||||||
Notes: | ||||||||||||||
1 | Acquisition and integration related costs for 2020 primarily includes a Contingent Consideration reversal ($165M in third quarter and $1,148M in nine months) related to the timing of certain developmental milestones associated with the Auris Health acquisition. | |||||||||||||
2 | 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 are 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 Medical Devices operating segments' measures of profit and loss used for making operating decisions and assessing performance. | |||||||||||||
3 | 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 Measures | ||||||||||||||
Nine Months Ended | ||||||||||||||
(Dollars in Millions Except Per Share Data) | 2020 | 2019 | ||||||||||||
Net Earnings, after tax- as reported | $12,976 | $11,109 | ||||||||||||
Pre-tax Adjustments | ||||||||||||||
Intangible Asset Amortization expense | 3,426 | 3,386 | ||||||||||||
Litigation expense, net | 2,210 | 4,832 | ||||||||||||
IPR&D | 144 | 890 | ||||||||||||
Restructuring related | 363 | 360 | ||||||||||||
Acquisition and Integration related ¹ | (1,087) | 229 | ||||||||||||
Unrealized (gains)/losses on securities | (174) | (217) | ||||||||||||
Medical Device Regulation 2 | 89 | - | ||||||||||||
Other | 6 | 7 | ||||||||||||
Tax Adjustments | ||||||||||||||
Tax impact on special item adjustments 3 | (1,002) | (1,922) | ||||||||||||
Tax legislation and related impacts | (483) | (391) | ||||||||||||
Adjusted Net Earnings, after tax | $16,468 | $18,283 | ||||||||||||
Average shares outstanding (Diluted) | 2,670.8 | 2,688.1 | ||||||||||||
Adjusted net earnings per share (Diluted) | $6.17 | $6.80 | ||||||||||||
Operational adjusted net earnings per share (Diluted) | $6.18 | |||||||||||||
Notes: | ||||||||||||||
1 | Acquisition and integration related costs for 2020 primarily includes a Contingent Consideration reversal ($165M in third quarter and $1,148M in nine months) related to the timing of certain developmental milestones associated with the Auris Health acquisition. | |||||||||||||
2 | 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 are 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 Medical Devices operating segments' measures of profit and loss used for making operating decisions and assessing performance. | |||||||||||||
3 | 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 (A) | ||||||||||||||||||||||||||
THIRD QUARTER 2020 ACTUAL vs. 2019 ACTUAL | ||||||||||||||||||||||||||
Segments | ||||||||||||||||||||||||||
Consumer Health | Pharmaceutical | Medical Devices | Total | |||||||||||||||||||||||
WW As Reported | 1.3 | % | 5.0 | % | (3.6) | % | 1.7 | % | ||||||||||||||||||
U.S. | 11.6 | % | 1.5 | % | 1.2 | % | 2.7 | % | ||||||||||||||||||
International | (5.6) | % | 9.7 | % | (8.1) | % | 0.6 | % | ||||||||||||||||||
WW Currency | (1.7) | 0.4 | 0.3 | 0.0 | ||||||||||||||||||||||
U.S. | — | — | — | — | ||||||||||||||||||||||
International | (2.9) | 0.9 | 0.4 | 0.0 | ||||||||||||||||||||||
WW Operational | 3.0 | % | 4.6 | % | (3.9) | % | 1.7 | % | ||||||||||||||||||
U.S. | 11.6 | % | 1.5 | % | 1.2 | % | 2.7 | % | ||||||||||||||||||
International | (2.7) | % | 8.8 | % | (8.5) | % | 0.6 | % | ||||||||||||||||||
General Surgery | ||||||||||||||||||||||||||
Advanced Sterilization Products | 0.5 | 0.2 | ||||||||||||||||||||||||
U.S. | 0.0 | 0.0 | ||||||||||||||||||||||||
International | 0.9 | 0.4 | ||||||||||||||||||||||||
Baby Care | ||||||||||||||||||||||||||
Baby Center | 0.1 | 0.0 | ||||||||||||||||||||||||
U.S. | 0.4 | 0.1 | ||||||||||||||||||||||||
International | 0.0 | 0.0 | ||||||||||||||||||||||||
All Other Acquisitions and Divestitures | 0.0 | 0.1 | 0.0 | 0.1 | ||||||||||||||||||||||
U.S. | 0.0 | 0.0 | 0.1 | 0.0 | ||||||||||||||||||||||
International | (0.1) | 0.3 | 0.0 | 0.1 | ||||||||||||||||||||||
WW Adjusted Operational | 3.1 | % | 4.7 | % | (3.3) | % | 2.0 | % | ||||||||||||||||||
U.S. | 12.0 | % | 1.5 | % | 1.3 | % | 2.8 | % | ||||||||||||||||||
International | (2.8) | % | 9.2 | % | (7.6) | % | 1.1 | % | ||||||||||||||||||
Note: Percentages are based on actual, non-rounded figures and may not sum | ||||||||||||||||||||||||||
(A) NON-GAAP FINANCIAL MEASURE “Adjusted operational sales growth" excludes acquisitions, divestitures and translational currency and is a non-GAAP financial measure. Investors should consider non-GAAP financial measures in addition to, and not as replacements for, or superior to, measures of financial performance prepared in accordance with GAAP. Due to the variable nature of acquisitions and divestitures, and the impact they may have on the analysis of underlying business performance and trends, management believes that providing this measure enhances an investor’s understanding of the Company’s performance and may assist in the evaluation of ongoing business operations period over period. This non-GAAP financial measure is presented to permit investors to more fully understand how management assesses the performance of the Company, including for internal evaluation of the performance of the Company's businesses and planning and forecasting for future periods. The use of this non-GAAP financial measure as a performance measure is limited in that it provides a view of the Company's results of operations without including all events during a period and may not provide a comparable view of the Company's performance to that of other companies in the health care industry. |
Johnson & Johnson and Subsidiaries | ||||||||||||||||||||||||||
Reconciliation of Non-GAAP Financial Measure | ||||||||||||||||||||||||||
Adjusted Operational Sales Growth (A) | ||||||||||||||||||||||||||
NINE MONTHS 2020 ACTUAL vs. 2019 ACTUAL | ||||||||||||||||||||||||||
Segments | ||||||||||||||||||||||||||
Consumer Health | Pharmaceutical | Medical Devices | Total | |||||||||||||||||||||||
WW As Reported | 1.0 | % | 5.2 | % | (15.3) | % | (2.0) | % | ||||||||||||||||||
U.S. | 11.1 | % | 5.2 | % | (15.1) | % | 0.0 | % | ||||||||||||||||||
International | (6.4) | % | 5.3 | % | (15.5) | % | (4.0) | % | ||||||||||||||||||
WW Currency | (2.4) | (0.9) | (0.7) | (1.2) | ||||||||||||||||||||||
U.S. | — | — | — | — | ||||||||||||||||||||||
International | (4.2) | (2.1) | (1.4) | (2.3) | ||||||||||||||||||||||
WW Operational | 3.4 | % | 6.1 | % | (14.6) | % | (0.8) | % | ||||||||||||||||||
U.S. | 11.1 | % | 5.2 | % | (15.1) | % | 0.0 | % | ||||||||||||||||||
International | (2.2) | % | 7.4 | % | (14.1) | % | (1.7) | % | ||||||||||||||||||
Skin Health / Beauty | ||||||||||||||||||||||||||
Dr. Ci Labo - Japan | (0.1) | 0.0 | ||||||||||||||||||||||||
U.S. | 0.0 | 0.0 | ||||||||||||||||||||||||
International | (0.2) | 0.0 | ||||||||||||||||||||||||
General Surgery | ||||||||||||||||||||||||||
Advanced Sterilization Products | 0.9 | 0.3 | ||||||||||||||||||||||||
U.S. | 0.8 | 0.3 | ||||||||||||||||||||||||
International | 0.9 | 0.4 | ||||||||||||||||||||||||
Baby Care | ||||||||||||||||||||||||||
Baby Center | 0.2 | 0.0 | ||||||||||||||||||||||||
U.S. | 0.6 | 0.1 | ||||||||||||||||||||||||
International | 0.0 | 0.0 | ||||||||||||||||||||||||
All Other Acquisitions and Divestitures | (0.1) | 0.2 | 0.0 | 0.1 | ||||||||||||||||||||||
U.S. | 0.0 | 0.0 | 0.0 | 0.0 | ||||||||||||||||||||||
International | (0.1) | 0.3 | 0.0 | 0.1 | ||||||||||||||||||||||
WW Adjusted Operational | 3.4 | % | 6.3 | % | (13.7) | % | (0.4) | % | ||||||||||||||||||
U.S. | 11.7 | % | 5.2 | % | (14.3) | % | 0.4 | % | ||||||||||||||||||
International | (2.6) | % | 7.7 | % | (13.1) | % | (1.3) | % | ||||||||||||||||||
Note: Percentages are based on actual, non-rounded figures and may not sum | ||||||||||||||||||||||||||
(A) NON-GAAP FINANCIAL MEASURE “Adjusted operational sales growth" excludes acquisitions, divestitures and translational currency and is a non-GAAP financial measure. Investors should consider non-GAAP financial measures in addition to, and not as replacements for, or superior to, measures of financial performance prepared in accordance with GAAP. Due to the variable nature of acquisitions and divestitures, and the impact they may have on the analysis of underlying business performance and trends, management believes that providing this measure enhances an investor’s understanding of the Company’s performance and may assist in the evaluation of ongoing business operations period over period. This non-GAAP financial measure is presented to permit investors to more fully understand how management assesses the performance of the Company, including for internal evaluation of the performance of the Company's businesses and planning and forecasting for future periods. The use of this non-GAAP financial measure as a performance measure is limited in that it provides a view of the Company's results of operations without including all events during a period and may not provide a comparable view of the Company's performance to that of other companies in the health care industry. |
Johnson & Johnson | |||||||||||||||||||||||||||||
Segment Sales | |||||||||||||||||||||||||||||
(Dollars in Millions) | |||||||||||||||||||||||||||||
THIRD QUARTER | |||||||||||||||||||||||||||||
% Change | |||||||||||||||||||||||||||||
2020 | 2019 | Reported | Operational (1) | Currency | |||||||||||||||||||||||||
CONSUMER HEALTH SEGMENT (2) (3) | |||||||||||||||||||||||||||||
OTC | |||||||||||||||||||||||||||||
US | $ | 601 | 477 | 26.0 | % | 26.0 | % | — | % | ||||||||||||||||||||
Intl | 541 | 621 | (12.9) | (12.9) | 0.0 | ||||||||||||||||||||||||
WW | 1,142 | 1,098 | 4.0 | 4.0 | 0.0 | ||||||||||||||||||||||||
SKIN HEALTH / BEAUTY (4) | |||||||||||||||||||||||||||||
US | 572 | 559 | 2.4 | 2.4 | — | ||||||||||||||||||||||||
Intl | 577 | 592 | (2.7) | (0.5) | (2.2) | ||||||||||||||||||||||||
WW | 1,149 | 1,151 | (0.2) | 0.9 | (1.1) | ||||||||||||||||||||||||
ORAL CARE | |||||||||||||||||||||||||||||
US | 164 | 156 | 5.5 | 5.5 | — | ||||||||||||||||||||||||
Intl | 248 | 223 | 10.7 | 14.4 | (3.7) | ||||||||||||||||||||||||
WW | 412 | 379 | 8.5 | 10.8 | (2.3) | ||||||||||||||||||||||||
BABY CARE | |||||||||||||||||||||||||||||
US | 91 | 91 | (1.0) | (1.0) | — | ||||||||||||||||||||||||
Intl | 302 | 326 | (7.2) | (0.6) | (6.6) | ||||||||||||||||||||||||
WW | 393 | 417 | (5.9) | (0.7) | (5.2) | ||||||||||||||||||||||||
WOMEN'S HEALTH | |||||||||||||||||||||||||||||
US | 3 | 3 | (6.9) | (6.9) | — | ||||||||||||||||||||||||
Intl | 227 | 252 | (9.6) | (4.0) | (5.6) | ||||||||||||||||||||||||
WW | 230 | 255 | (9.6) | (4.1) | (5.5) | ||||||||||||||||||||||||
WOUND CARE / OTHER | |||||||||||||||||||||||||||||
US | 125 | 109 | 15.2 | 15.2 | — | ||||||||||||||||||||||||
Intl | 64 | 59 | 7.4 | 10.3 | (2.9) | ||||||||||||||||||||||||
WW | 189 | 168 | 12.5 | 13.5 | (1.0) | ||||||||||||||||||||||||
TOTAL CONSUMER HEALTH | |||||||||||||||||||||||||||||
US | 1,556 | 1,394 | 11.6 | 11.6 | — | ||||||||||||||||||||||||
Intl | 1,958 | 2,075 | (5.6) | (2.7) | (2.9) | ||||||||||||||||||||||||
WW | $ | 3,514 | 3,469 | 1.3 | % | 3.0 | % | (1.7) | % | ||||||||||||||||||||
See footnotes at end of schedule |
Johnson & Johnson | |||||||||||||||||||||||||||||
Segment Sales | |||||||||||||||||||||||||||||
(Dollars in Millions) | |||||||||||||||||||||||||||||
THIRD QUARTER | |||||||||||||||||||||||||||||
% Change | |||||||||||||||||||||||||||||
2020 | 2019 | Reported | Operational (1) | Currency | |||||||||||||||||||||||||
PHARMACEUTICAL SEGMENT (2) (5) | |||||||||||||||||||||||||||||
IMMUNOLOGY | |||||||||||||||||||||||||||||
US | $ | 2,558 | 2,582 | (0.9) | % | (0.9) | % | — | % | ||||||||||||||||||||
Intl | 1,230 | 1,129 | 9.0 | 8.4 | 0.6 | ||||||||||||||||||||||||
WW | 3,789 | 3,711 | 2.1 | 1.9 | 0.2 | ||||||||||||||||||||||||
REMICADE | |||||||||||||||||||||||||||||
US | 634 | 749 | (15.4) | (15.4) | — | ||||||||||||||||||||||||
US Exports (6) | 78 | 88 | (11.3) | (11.3) | — | ||||||||||||||||||||||||
Intl | 209 | 299 | (30.1) | (28.0) | (2.1) | ||||||||||||||||||||||||
WW | 921 | 1,136 | (18.9) | (18.4) | (0.5) | ||||||||||||||||||||||||
SIMPONI / SIMPONI ARIA | |||||||||||||||||||||||||||||
US | 312 | 313 | (0.4) | (0.4) | — | ||||||||||||||||||||||||
Intl | 280 | 273 | 2.4 | 2.2 | 0.2 | ||||||||||||||||||||||||
WW | 592 | 586 | 0.9 | 0.8 | 0.1 | ||||||||||||||||||||||||
STELARA | |||||||||||||||||||||||||||||
US | 1,313 | 1,212 | 8.4 | 8.4 | — | ||||||||||||||||||||||||
Intl | 634 | 487 | 30.3 | 28.1 | 2.2 | ||||||||||||||||||||||||
WW | 1,947 | 1,698 | 14.7 | 14.0 | 0.7 | ||||||||||||||||||||||||
TREMFYA | |||||||||||||||||||||||||||||
US | 222 | 221 | 0.4 | 0.4 | — | ||||||||||||||||||||||||
Intl | 105 | 69 | 54.4 | 50.4 | 4.0 | ||||||||||||||||||||||||
WW | 327 | 290 | 13.1 | 12.2 | 0.9 | ||||||||||||||||||||||||
OTHER IMMUNOLOGY | |||||||||||||||||||||||||||||
US | — | — | — | — | — | ||||||||||||||||||||||||
Intl | 3 | 2 | 35.6 | 44.6 | (9.0) | ||||||||||||||||||||||||
WW | 3 | 2 | 35.6 | 44.6 | (9.0) | ||||||||||||||||||||||||
INFECTIOUS DISEASES | |||||||||||||||||||||||||||||
US | 413 | 418 | (1.1) | (1.1) | — | ||||||||||||||||||||||||
Intl | 451 | 421 | 7.0 | 6.3 | 0.7 | ||||||||||||||||||||||||
WW | 864 | 839 | 3.0 | 2.6 | 0.4 | ||||||||||||||||||||||||
EDURANT / rilpivirine | |||||||||||||||||||||||||||||
US | 11 | 12 | (12.0) | (12.0) | — | ||||||||||||||||||||||||
Intl | 226 | 206 | 9.3 | 5.0 | 4.3 | ||||||||||||||||||||||||
WW | 236 | 218 | 8.1 | 4.1 | 4.0 | ||||||||||||||||||||||||
PREZISTA / PREZCOBIX / REZOLSTA / SYMTUZA | |||||||||||||||||||||||||||||
US | 379 | 373 | 1.5 | 1.5 | — | ||||||||||||||||||||||||
Intl | 147 | 135 | 9.1 | 12.1 | (3.0) | ||||||||||||||||||||||||
WW | 526 | 508 | 3.5 | 4.3 | (0.8) | ||||||||||||||||||||||||
OTHER INFECTIOUS DISEASES | |||||||||||||||||||||||||||||
US | 24 | 33 | (26.6) | (26.6) | — | ||||||||||||||||||||||||
Intl | 78 | 80 | (2.3) | (0.4) | (1.9) | ||||||||||||||||||||||||
WW |