Johnson & Johnson Reports 2020 Fourth-Quarter And Full Year Results

- Johnson & Johnson (NYSE: JNJ) today announced results for fourth-quarter and full year 2020. "Our notable full year performance reflects the continued confidence from patients, physicians, customers and consumers in our life-enhancing products and medicines, particularly throughout the COVID-19 pandemic," said Alex Gorsky Chairman and Chief Executive Officer. "I'm incredibly proud of our Johnson & Johnson teams around the world for going above and beyond to meet stakeholder needs. These efforts, and our commitment to families around the world as the largest broad-based healthcare company, enabled us to lead in the fight against COVID-19. We continue to progress our COVID-19 vaccine candidate and look forward to sharing details from our Phase 3 study soon. Johnson & Johnson was built for times like these, and I am extremely confident in our ability to deliver lasting value and continued innovation in 2021 and for years to come."

OVERALL FINANCIAL RESULTS:


FOURTH QUARTER



TWELVE MONTHS


($ in Millions, except EPS)

2020

2019

%  Change


2020

2019

%  Change

Reported Sales

$ 22,475

$ 20,747

8.3%


$ 82,584

$ 82,059

0.6%

Net Earnings

1,738

4,010

(56.7)%


14,714

15,119

(2.7)%

EPS (diluted)

$      0.65

$      1.50

(56.7)%


$      5.51

$      5.63

(2.1)%









Non-GAAP*

FOURTH QUARTER



TWELVE MONTHS


($ in Millions, except EPS)

2020

2019

%  Change


2020

2019

%  Change

Operational Sales 1,2

N/A

N/A

7.1%


N/A

N/A

1.2%

Adjusted Operational Sales 1,3

N/A

N/A

7.3%


N/A

N/A

1.5%

Adjusted Net Earnings 1,4

4,965

5,027

(1.2)%


21,433

23,310

(8.1)%

Adjusted EPS (diluted) 1,4

$      1.86

$      1.88

(1.1)%


$      8.03

$      8.68

(7.5)%


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

REGIONAL SALES RESULTS:


FOURTH QUARTER

%  Change

($ in Millions) 1

2020   2

2019   2

Reported   2

Operational   1,2

Currency   2

Adjusted
Operational 1,3

U.S.

$ 11,809

$ 10,774

9.6%

9.6%

-

9.6

International

10,666

9,973

7.0%

4.3%

2.7

4.8

Worldwide

$ 22,475

$ 20,747

8.3%

7.1%

1.2

7.3























TWELVE MONTHS

%  Change

($ in Millions) 1

2020   2

2019   2

Reported   2

Operational   1,2

Currency   2

Adjusted
Operational 1,3

U.S.

$ 43,133

$ 42,097

2.5%

2.5

-

2.8

International

39,451

39,962

(1.3)%

(0.2)

(1.1)

0.2

Worldwide

$ 82,584

$ 82,059

0.6%

1.2

(0.6)

1.5


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:


FOURTH QUARTER

%  Change

($ in Millions) 1

2020   1

2019   1

Reported   2

Operational   1,2

Currency   1

Adjusted
Operational 1,3

Consumer Health

$       3,618

$       3,567

1.4%

2.0

(0.6)

2.1

Pharmaceutical

12,268

10,548

16.3%

14.6

1.7

14.6

Medical Devices

6,589

6,632

(0.7)%

(2.2)

1.5

(1.5)

Worldwide

$     22,475

$     20,747

8.3%

7.1

1.2

7.3
















TWELVE MONTHS

%  Change

($ in Millions) 1

2020   1

2019   1

Reported   2

Operational   1,2

Currency   1

Adjusted
Operational 1,3

Consumer Health

$     14,053

$     13,898

1.1%

3.0

(1.9)

3.1

Pharmaceutical

45,572

42,198

8.0%

8.2

(0.2)

8.4

Medical Devices

22,959

25,963

(11.6)%

(11.4)

(0.2)

(10.5)

Worldwide

$     82,584

$     82,059

0.6%

1.2

(0.6)

1.5


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 2020 SEGMENT COMMENTARY:

Consumer Health
Consumer Health worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 3.1%* driven by U.S. growth in over-the-counter products including TYLENOL analgesics, PEPCID and ZYRTEC; LISTERINE mouthwash in oral care products; OGX in skin health/beauty products and wound care products.  Growth was negatively impacted by COVID-19 primarily in skin health/beauty and international baby care partially offset by increased COVID-19 demand in oral care products.

Pharmaceutical
Pharmaceutical worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 8.4%* driven by STELARA (ustekinumab), a biologic for the treatment of a number of immune-mediated inflammatory diseases, DARZALEX (daratumumab), for the treatment of multiple myeloma, IMBRUVICA (ibrutinib), an oral, once-daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer, ERLEADA (apalutamide), a next-generation androgen receptor inhibitor for the treatment of patients with prostate cancer, TREMFYA (guselkumab), a biologic for the treatment of adults living with moderate to severe plaque psoriasis, and for adults with active psoriatic arthritis,   INVEGA SUSTENNA/XEPLION/INVEGA TRINZA/TREVICTA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults, OPSUMIT (macitentan), an oral endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension to delay disease progression and UPTRAVI (selexipag), an oral prostacyclin receptor agonist used to treat pulmonary arterial hypertension and reduce hospitalization. This growth was partially offset by the negative impact of COVID-19 as well as biosimilar and generic competition, with declines primarily in REMICADE (infliximab), a biologic approved for the treatment of a number of immune-mediated inflammatory diseases, U.S. ZYTIGA (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic castration-resistant prostate cancer, and international VELCADE (bortezomib), a proteasome inhibitor for the treatment of multiple myeloma.

Medical Devices  
Medical Devices worldwide operational sales, excluding the net impact of acquisitions and divestitures, declined by 10.5%*. The decline was primarily driven by the negative impact of the COVID-19 pandemic and the associated deferral of medical procedures to our Surgery, Orthopaedics, and Vision businesses. The decline was partially offset by growth in the Interventional Solutions business led by electrophysiology products. Results reflect market recovery in the second half of 2020.

NOTABLE NEW ANNOUNCEMENTS IN THE QUARTER:  
The information contained in this section should be read in conjunction 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 available online in the Investors section of the company's website at news releases .

Regulatory Approvals

VELYS Robotic-Assisted Solution- Receives 510(k) FDA Clearance Designed for Use with the ATTUNE Total Knee System ¹

(press release)

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj)- Becomes the First FDA-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL) Amyloidosis ¹

(press release)

CABENUVA (rilpivirine/cabotegravir)- U.S. FDA Approval and European Commission Authorization of the first complete long acting injectable HIV treatment ¹

(press release)

(press release)

TREMFYA (guselkumab)- European Commission Approves First-in-Class treatment for Active Psoriatic Arthritis (PsA)

(press release)

Regulatory Submissions

Amivantamab- Submission of U.S. FDA and European Marketing Authorization Application for Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

(press release)
(press release)

BCMA CAR-T Therapy (ciltacabtagene autoleucel)- Rolling Submission of a Biologics License Application to U.S. FDA for the Treatment of Relapsed and/or Refractory Multiple Myeloma

(press release)

DARZALEX (daratumumab and hyaluronidase-fihj)- Janssen Submits Applications in U.S. and EU Seeking Approval of DARZALEX FASPRO (daratumumab and hyaluronidase-fihj)/DARZALEX (daratumumab) Subcutaneous (SC) Formulation in Combination With Pomalidomide and Dexamethasone for Patients With Relapsed or Refractory Multiple Myeloma

(press release)

Paliperidone Palmitate 6-Month- Submission of Supplemental New Drug Application to U.S. FDA and European Marketing Authorization for Treatment of Schizophrenia in Adults

(press release)

(press release)

XARELTO (rivaroxaban)- Submission of Application to U.S. FDA for New Indication to Expand Use in Patients with Peripheral Artery Disease

(press release)

Other

Janssen Receives Positive CHMP Opinion for SPRAVATO (esketamine Nasal Spray) for the Rapid Reduction of Depressive Symptoms in a Psychiatric Emergency for Patients with Major Depressive Disorder

(press release)

Janssen Acquires Rights to Novel Gene Therapy, Pioneering Treatment Solutions for Late-Stage Age-Related Macular Degeneration

(press release)

Johnson & Johnson Initiates Second Global Phase 3 Clinical Trial of its Janssen COVID-19 Vaccine Candidate

(press release)


1 Subsequent to the quarter

FULL-YEAR 2021 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.


January 2021

($ in Billions, except EPS)


Adjusted Operational Sales 1,2

Change vs. Prior Year

8.0% - 9.5%

Operational Sales 2

Change vs. Prior Year

$88.8B - $90.0B

7.5% – 9.0%

Estimated Reported Sales 3

Change vs. Prior Year

$90.5B - $91.7B

9.5% – 11.0%



Adjusted Operational EPS (Diluted) 2,4

Change vs. Prior Year

$9.25 - $9.45

15.2% - 17.7%

Adjusted EPS (Diluted) 3,4

Change vs. Prior Year

$9.40 - $9.60

17.1% - 19.6%


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 2021 = $1.21 (Illustrative purposes only)

4 Non-GAAP financial measure; excludes intangible amortization expense and special items

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 Investors section of the company's website at events-and-presentations .

ABOUT JOHNSON & JOHNSON:
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That's why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world's largest and most broadly-based health care company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity.

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 Investors 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, a pharmaceutical pipeline of selected compounds in late stage development and a copy of today's earnings call presentation can also be found in the Investors 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, 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: risks related to the impact of the COVID-19 global pandemic, such as the scope and duration of the outbreak, government actions and restrictive measures implemented in response, material delays and cancellations of medical procedures, supply chain disruptions and other impacts to the business, or on the Company's ability to execute business continuity plans, as a result of the COVID-19 pandemic, 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; 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. 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 29, 2019 , including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," in the Company's most recently filed Quarterly Report on Form 10-Q and the Company's subsequent 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.

Johnson & Johnson and Subsidiaries
















Supplementary Sales Data




































(Unaudited; Dollars in Millions)

FOURTH QUARTER


TWELVE MONTHS






Percent Change






Percent Change


2020


2019


Total


Operations


Currency


2020


2019


Total


Operations


Currency

Sales to customers by




















geographic area








































U.S.

$ 11,809


10,774


9.6

%

9.6


-


$ 43,133


42,097


2.5

%

2.5


-





















Europe

5,271


4,663


13.0


7.7


5.3


18,980


18,466


2.8


2.0


0.8

Western Hemisphere excluding U.S.

1,404


1,495


(6.1)


2.9


(9.0)


5,335


5,941


(10.2)


0.4


(10.6)

Asia-Pacific, Africa

3,991


3,815


4.6


0.7


3.9


15,136


15,555


(2.7)


(3.1)


0.4

International

10,666


9,973


7.0


4.3


2.7


39,451


39,962


(1.3)


(0.2)


(1.1)





















Worldwide

$ 22,475


20,747


8.3

%

7.1


1.2


$ 82,584


82,059


0.6

%

1.2


(0.6)





















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)

FOURTH QUARTER


TWELVE MONTHS






Percent Change






Percent Change


2020


2019


Total


Operations


Currency


2020


2019


Total


Operations


Currency

Sales to customers by




















segment of business








































Consumer Health




















U.S.

$   1,509


1,470


2.7

%

2.7


-


$   6,362


5,839


9.0

%

9.0


-

International

2,109


2,097


0.5


1.5


(1.0)


7,691


8,059


(4.6)


(1.3)


(3.3)


3,618


3,567


1.4


2.0


(0.6)


14,053


13,898


1.1


3.0


(1.9)





















Pharmaceutical




















U.S.

7,116


6,169


15.3


15.3


-


25,735


23,874


7.8


7.8


-

International

5,152


4,379


17.7


13.5


4.2


19,837


18,324


8.3


8.8


(0.5)


12,268


10,548


16.3


14.6


1.7


45,572


42,198


8.0


8.2


(0.2)





















Medical Devices




















U.S.

3,184


3,135


1.5


1.5


-


11,036


12,384


(10.9)


(10.9)


-

International

3,405


3,497


(2.6)


(5.5)


2.9


11,923


13,579


(12.2)


(11.8)


(0.4)


6,589


6,632


(0.7)


(2.2)


1.5


22,959


25,963


(11.6)


(11.4)


(0.2)





















U.S.

11,809


10,774


9.6


9.6


-


43,133


42,097


2.5


2.5


-

International

10,666


9,973


7.0


4.3


2.7


39,451


39,962


(1.3)


(0.2)


(1.1)

Worldwide

$ 22,475


20,747


8.3

%

7.1


1.2


$ 82,584


82,059


0.6

%

1.2


(0.6)




















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)

FOURTH QUARTER












2020


2019


Percent




Percent




Percent


Increase


Amount


to Sales


Amount


to Sales


(Decrease)

Sales to customers

$ 22,475


100.0


$ 20,747


100.0


8.3

Cost of products sold

7,814


34.8


7,134


34.4


9.5

Gross Profit

14,661


65.2


13,613


65.6


7.7

Selling, marketing and administrative expenses

6,457


28.7


6,039


29.1


6.9

Research and development expense

4,032


17.9


3,232


15.6


24.8

In-process research and development

37


0.2


-


-



Interest (income) expense, net

74


0.3


4


0.0



Other (income) expense, net

2,354


10.5


16


0.1



Restructuring

60


0.3


104


0.5



Earnings before provision for taxes on income

1,647


7.3


4,218


20.3


(61.0)

Provision for/(Benefit from) taxes on income

(91)


(0.4)


208


1.0


(143.8)

Net earnings

$   1,738


7.7


$   4,010


19.3


(56.7)











Net earnings per share (Diluted)

$     0.65




$     1.50




(56.7)











Average shares outstanding (Diluted)

2,669.2




2,669.1















Effective tax rate

(5.5)

%



4.9

%














Adjusted earnings before provision for taxes and net earnings (1)










Earnings before provision for taxes on income

$   5,601


24.9


$   5,628


27.1


(0.5)

Net earnings

$   4,965


22.1


$   5,027


24.2


(1.2)

Net earnings per share (Diluted)

$     1.86




$     1.88




(1.1)

Effective tax rate

11.4

%



10.7

%














(1) See Reconciliation of Non-GAAP Financial Measures.

Johnson & Johnson and Subsidiaries

Condensed Consolidated Statement of Earnings











(Unaudited; in Millions Except Per Share Figures)

TWELVE MONTHS












2020


2019


Percent




Percent




Percent


Increase


Amount


to Sales


Amount


to Sales


(Decrease)

Sales to customers

$ 82,584


100.0


$ 82,059


100.0


0.6

Cost of products sold

28,427


34.4


27,556


33.6


3.2

Gross Profit

54,157


65.6


54,503


66.4


(0.6)

Selling, marketing and administrative expenses

22,084


26.8


22,178


27.0


(0.4)

Research and development expense

12,159


14.7


11,355


13.8


7.1

In-process research and development

181


0.2


890


1.1



Interest (income) expense, net

90


0.1


(39)


0.0



Other (income) expense, net

2,899


3.5


2,525


3.1



Restructuring

247


0.3


266


0.3



Earnings before provision for taxes on income

16,497


20.0


17,328


21.1


(4.8)

Provision for taxes on income

1,783


2.2


2,209


2.7


(19.3)

Net earnings

$ 14,714


17.8


$ 15,119


18.4


(2.7)











Net earnings per share (Diluted)

$     5.51




$     5.63




(2.1)











Average shares outstanding (Diluted)

2,670.7




2,684.3















Effective tax rate

10.8

%



12.7

%














Adjusted earnings before provision for taxes and net earnings (1)










Earnings before provision for taxes on income

$ 25,428


30.8


$ 28,225


34.4


(9.9)

Net earnings

$ 21,433


26.0


$ 23,310


28.4


(8.1)

Net earnings per share (Diluted)

$     8.03




$     8.68




(7.5)

Effective tax rate

15.7

%



17.4

%














(1) See Reconciliation of Non-GAAP Financial Measures.

Johnson & Johnson and Subsidiaries

Reconciliation of Non-GAAP Financial Measures










Fourth Quarter


Twelve Months Ended

(Dollars in Millions Except Per Share Data)

2020


2019


2020


2019

Net Earnings, after tax- as reported

$1,738


$4,010


$14,714


$15,119









Pre-tax Adjustments








Intangible Asset Amortization expense

1,234


1,142


4,660


4,528

Litigation expense, net

2,902


264


5,112


5,096

IPR&D

37


-


181


890

Restructuring related

85


251


448


611

Acquisition and Integration related ¹

14


90


(1,073)


319

Unrealized (gains)/losses on securities

(373)


(350)


(547)


(567)

Medical Device Regulation 2

55


-


144


-

Other

-


13


6


20









Tax Adjustments








Tax impact on special item adjustments 3

(606)


(123)


(1,608)


(1,977)

Tax legislation and other tax related

(121)


(270)


(604)


(729)

Adjusted Net Earnings, after tax

$4,965


$5,027


$21,433


$23,310

Average shares outstanding (Diluted)

2,669.2


2,669.1


2,670.7


2,684.3

Adjusted net earnings per share (Diluted)

$1.86


$1.88


$8.03


$8.68

Operational adjusted net earnings per share (Diluted)

$1.82




$8.00






Notes:

1

Acquisition and integration related costs for 2020 primarily includes a Contingent Consideration reversal of $1,148M 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.




Prior year amounts have been reclassified to conform to current year disclosure

Johnson & Johnson and Subsidiaries

Reconciliation of Non-GAAP Financial Measure










Adjusted Operational Sales Growth

FOURTH QUARTER 2020 ACTUAL vs. 2019 ACTUAL










Segments












Consumer Health


Pharmaceutical


Medical Devices


Total










WW As Reported


1.4%


16.3%


(0.7)%


8.3%

U.S.


2.7%


15.3%


1.5%


9.6%

International


0.5%


17.7%


(2.6)%


7.0%










WW Currency


(0.6)


1.7


1.5


1.2

U.S.


-


-


-


-

International


(1.0)


4.2


2.9


2.7










WW Operational


2.0%


14.6%


(2.2)%


7.1%

U.S.


2.7%


15.3%


1.5%


9.6%

International


1.5%


13.5%


(5.5)%


4.3%










General Surgery









Advanced Sterilization Products






0.6


0.2

U.S.






0.0


0.0

International






1.0


0.4










All Other Acquisitions and Divestitures


0.1


0.0


0.1


0.1

U.S.


0.1


(0.1)


0.2


0.0

International


0.1


0.2


0.0


0.1










WW Adjusted Operational


2.1%


14.6%


(1.5)%


7.3%

U.S.


2.8%


15.2%


1.7%


9.6%

International


1.6%


13.7%


(4.4)%


4.8%










Note: Percentages are based on actual, non-rounded figures and may not sum

Johnson & Johnson and Subsidiaries

Reconciliation of Non-GAAP Financial Measure










Adjusted Operational Sales Growth

TWELVE MONTHS 2020 ACTUAL vs. 2019 ACTUAL


Segments












Consumer Health


Pharmaceutical


Medical Devices


Total










WW As Reported


1.1%


8.0%


(11.6)%


0.6%

U.S.


9.0%


7.8%


(10.9)%


2.5%

International


(4.6)%


8.3%


(12.2)%


(1.3)%










WW Currency


(1.9)


(0.2)


(0.2)


(0.6)

U.S.


-


-


-


-

International


(3.3)


(0.5)


(0.4)


(1.1)










WW Operational


3.0%


8.2%


(11.4)%


1.2%

U.S.


9.0%


7.8%


(10.9)%


2.5%

International


(1.3)%


8.8%


(11.8)%


(0.2)%










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






0.8


0.3

U.S.






0.6


0.2

International






1.0


0.4










Baby Care









Baby Center


0.2






0.0

U.S.


0.5






0.1

International


0.0






0.0










All Other Acquisitions and Divestitures


0.0


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


3.1%


8.4%


(10.5)%


1.5%

U.S.


9.5%


7.8%


(10.2)%


2.8%

International


(1.5)%


9.1%


(10.9)%


0.2%










Note : Percentages are based on actual, non-rounded figures and may not sum


REPORTED SALES vs. PRIOR PERIOD ($MM)




REPORTED SALES vs. PRIOR PERIOD ($MM)



FOURTH QUARTER




TWELVE MONTHS







% Change





% Change




2020


2019

Reported

Operational (1)

Currency





2020


2019

Reported

Operational (1)

Currency


CONSUMER HEALTH SEGMENT (2,3)



















OTC



















US


$          543


542

0.1%

0.1%

-





$        2,460


2,010

22.4%

22.4%

-


Intl


642


653

-1.7%

-2.9%

1.2%





2,364


2,434

-2.9%

-1.2%

-1.7%


WW


1,185


1,195

-0.8%

-1.5%

0.7%





4,824


4,444

8.5%

9.4%

-0.9%


SKIN HEALTH / BEAUTY (4)



















US


583


582

0.2%

0.2%

-





2,350


2,392

-1.7%

-1.7%

-


Intl


594


568

4.6%

5.0%

-0.4%





2,100


2,201

-4.6%

-2.3%

-2.3%


WW


1,177


1,150

2.4%

2.6%

-0.2%





4,450


4,593

-3.1%

-2.0%

-1.1%


ORAL CARE



















US


173


159

8.3%

8.3%

-





683


621

9.9%

9.9%

-


Intl


264


233

13.5%

14.5%

-1.0%





958


906

5.7%

9.6%

-3.9%


WW


437


393

11.4%

12.0%

-0.6%





1,641


1,528

7.4%

9.7%

-2.3%


BABY CARE



















US


97


85

14.3%

14.3%

-





376


362

3.7%

3.7%

-


Intl


310


336

-7.8%

-3.6%

-4.2%





1,141


1,313

-13.1%

-7.3%

-5.8%


WW


407


421

-3.4%

0.0%

-3.4%





1,517


1,675

-9.4%

-4.9%

-4.5%


WOMEN'S HEALTH



















US


3


3

11.8%

11.8%

-





13


12

8.2%

8.2%

-


Intl


234


250

-6.5%

-3.1%

-3.4%





888


974

-8.8%

-2.9%

-5.9%


WW


237


253

-6.3%

-2.9%

-3.4%





901


986

-8.6%

-2.7%

-5.9%


WOUND CARE / OTHER



















US


110


98

11.8%

11.8%

-





480


441

8.9%

8.9%

-


Intl


65


57

12.4%

13.0%

-0.6%





240


230

4.1%

7.3%

-3.2%


WW


175


155

12.0%

12.2%

-0.2%





720


671

7.2%

8.3%

-1.1%





















TOTAL CONSUMER HEALTH



















US


1,509


1,470

2.7%

2.7%

-





6,362


5,839

9.0%

9.0%

-


Intl


2,109


2,097

0.5%

1.5%

-1.0%





7,691


8,059

-4.6%

-1.3%

-3.3%


WW


$       3,618


3,567

1.4%

2.0%

-0.6%





$      14,053


13,898

1.1%

3.0%

-1.9%








































See footnotes at end of schedule






































































REPORTED SALES vs. PRIOR PERIOD ($MM)




REPORTED SALES vs. PRIOR PERIOD ($MM)



FOURTH QUARTER




TWELVE MONTHS




% Change





% Change


PHARMACEUTICAL SEGMENT (2,5)


2020


2019

Reported

Operational (1)

Currency





2020


2019

Reported

Operational (1)

Currency





















IMMUNOLOGY



















US


$       2,845


2,517

13.0%

13.0%

-





$      10,175


9,641

5.5%

5.5%

-


Intl


1,261


1,005

25.4%

21.1%

4.3%





4,880


4,309

13.2%

14.0%

-0.8%


WW


4,105


3,522

16.6%

15.3%

1.3%





15,055


13,950

7.9%

8.2%

-0.3%


REMICADE



















US


656


755

-13.1%

-13.1%

-





2,508


3,079

-18.5%

-18.5%

-


US Exports (6)


25


68

-62.4%

-62.4%

-





346


294

18.0%

18.0%

-


Intl


220


212

3.3%

2.7%

0.6%





893


1,007

-11.4%

-8.6%

-2.8%


WW


901


1,035

-12.9%

-13.1%

0.2%





3,747


4,380

-14.4%

-13.8%

-0.6%


SIMPONI / SIMPONI ARIA



















US


315


302

4.4%

4.4%

-





1,155


1,159

-0.3%

-0.3%

-


Intl


261


213

22.9%

18.8%

4.1%





1,088


1,029

5.8%

7.0%

-1.2%


WW


576


515

12.1%

10.4%

1.7%





2,243


2,188

2.6%

3.1%

-0.5%


STELARA



















US


1,572


1,194

31.6%

31.6%

-





5,240


4,346

20.6%

20.6%

-


Intl


672


506

32.7%

27.2%

5.5%





2,467


2,015

22.4%

22.2%

0.2%


WW


2,244


1,700

31.9%

30.3%

1.6%





7,707


6,361

21.1%

21.1%

0.0%


TREMFYA



















US


276


199

39.1%

39.1%

-





926


764

21.3%

21.3%

-


Intl


105


71

48.1%

40.0%

8.1%





421


248

69.9%

67.9%

2.0%


WW


382


270

41.5%

39.3%

2.2%





1,347


1,012

33.2%

32.7%

0.5%


OTHER IMMUNOLOGY



















US


-


-

-

-

-





-


-

-

-

-


Intl


2


2

-19.7%

-14.5%

-5.2%





11


10

6.4%

12.8%

-6.4%


WW


2


2

-19.7%

-14.5%

-5.2%





11


10

6.4%

12.8%

-6.4%


INFECTIOUS DISEASES



















US


470


435

7.9%

7.9%

-





1,735


1,597

8.6%

8.6%

-


Intl


442


430

2.8%

-2.6%

5.4%





1,839


1,815

1.3%

2.2%

-0.9%


WW


912


866

5.4%

2.7%

2.7%





3,574


3,413

4.7%

5.2%

-0.5%


EDURANT / rilpivirine



















US


11


14

-17.9%

-17.9%

-





44


50

-11.2%

-11.2%

-


Intl


236


209

13.4%

6.2%

7.2%





920


812

13.3%

11.9%

1.4%


WW


248


222

11.4%

4.7%

6.7%





964


861

11.9%

10.5%

1.4%


PREZISTA / PREZCOBIX / REZOLSTA / SYMTUZA



















US


433


390

11.1%

11.1%

-





1,587


1,422

11.6%

11.6%

-


Intl


136


155

-12.4%

-17.1%

4.7%





597


689

-13.4%

-10.7%

-2.7%


WW


569


544

4.4%

3.1%

1.3%





2,184


2,110

3.5%

4.4%

-0.9%


OTHER INFECTIOUS DISEASES



















US


25


32

-20.4%

-20.4%

-





104


126

-17.6%

-17.6%

-


Intl


71


67

5.2%

3.3%

1.9%





323


315

2.6%

5.6%

-3.0%


WW


96


99

-3.0%

-4.3%

1.3%





427


441

-3.2%

-1.0%

-2.2%









































REPORTED SALES vs. PRIOR PERIOD ($MM)




REPORTED SALES vs. PRIOR PERIOD ($MM)



FOURTH QUARTER




TWELVE MONTHS




% Change





% Change




2020


2019

Reported

Operational (1)

Currency





2020


2019

Reported

Operational (1)

Currency


NEUROSCIENCE



















US


806


747

7.9%

7.9%

-





3,091


2,919

5.9%

5.9%

-


Intl


892


819

9.0%

6.2%

2.8%





3,457


3,409

1.4%

2.2%

-0.8%


WW


1,698


1,566

8.5%

7.0%

1.5%





6,548


6,328

3.5%

3.9%

-0.4%


CONCERTA / Methylphenidate



















US


33


37

-9.7%

-9.7%

-





183


233

-21.4%

-21.4%

-


Intl


120


115

4.2%

1.4%

2.8%





439


463

-5.1%

-4.5%

-0.6%


WW


153


152

0.9%

-1.2%

2.1%





622


696

-10.6%

-10.2%

-0.4%


INVEGA SUSTENNA / XEPLION /
INVEGA TRINZA / TREVICTA



















US


610


564

8.1%

8.1%

-





2,314


2,107

9.8%

9.8%

-


Intl


355


308

15.7%

10.8%

4.9%





1,339


1,224

9.4%

9.1%

0.3%


WW


965


871

10.8%

9.0%

1.8%





3,653


3,330

9.7%

9.6%

0.1%


RISPERDAL CONSTA



















US


76


77

-2.5%

-2.5%

-





296


314

-5.9%

-5.9%

-


Intl


92


82

11.0%

7.7%

3.3%





346


374

-7.5%

-6.9%

-0.6%


WW


167


160

4.4%

2.7%

1.7%





642


688

-6.8%

-6.4%

-0.4%


OTHER NEUROSCIENCE



















US


88


70

27.4%

27.4%

-





298


266

12.4%

12.4%

-


Intl


326


314

3.7%

3.1%

0.6%





1,334


1,349

-1.1%

0.7%

-1.8%


WW


414


383

8.0%

7.5%

0.5%





1,632


1,614

1.1%

2.6%

-1.5%


ONCOLOGY



















US


1,469


1,153

27.4%

27.4%

-





5,092


4,299

18.5%

18.5%

-


Intl


1,965


1,563

25.7%

20.9%

4.8%





7,275


6,393

13.8%

14.0%

-0.2%


WW


3,434


2,716

26.4%

23.7%

2.7%





12,367


10,692

15.7%

15.8%

-0.1%


DARZALEX



















US


692


444

55.6%

55.6%

-





2,232


1,567

42.4%

42.4%

-


Intl


561


385

45.4%

41.3%

4.1%





1,958


1,430

36.9%

38.0%

-1.1%


WW


1,253


830

50.9%

49.0%

1.9%





4,190


2,998

39.8%

40.3%

-0.5%


ERLEADA



















US


176


103

70.8%

70.8%

-





583


297

96.1%

96.1%

-


Intl


64


13

*

*

*





176


35

*

*

*


WW


241


116

*

*

*





760


332

*

*

*


IMBRUVICA



















US


492


392

25.8%

25.8%

-





1,821


1,555

17.1%

17.1%

-


Intl


625


483

29.3%

24.8%

4.5%





2,307


1,856

24.3%

25.1%

-0.8%


WW


1,117


875

27.8%

25.3%

2.5%





4,128


3,411

21.0%

21.5%

-0.5%


VELCADE



















US


-


-

-

-

-





-


-

-

-

-


Intl


97


115

-15.2%

-18.5%

3.3%





408


751

-45.7%

-45.8%

0.1%


WW


97


115

-15.2%

-18.5%

3.3%





408


751

-45.7%

-45.8%

0.1%


ZYTIGA / abiraterone acetate



















US


89


194

-54.3%

-54.3%

-





373


810

-54.0%

-54.0%

-


Intl


533


483

10.2%

4.3%

5.9%





2,097


1,985

5.6%

4.7%

0.9%


WW


622


677

-8.3%

-12.5%

4.2%





2,470


2,795

-11.6%

-12.3%

0.7%


OTHER ONCOLOGY



















US


20


19

2.6%

2.6%

-





83


70

19.2%

19.2%

-


Intl


86


84

1.5%

-2.1%

3.6%





330


336

-1.9%

-1.4%

-0.5%


WW


105


104

1.7%

-1.2%

2.9%





413


407

1.7%

2.2%

-0.5%


PULMONARY HYPERTENSION



















US


592


388

52.5%

52.5%

-





2,133


1,684

26.6%

26.6%

-


Intl


273


235

16.8%

12.5%

4.3%





1,015


939

8.2%

8.0%

0.2%


WW


865


623

39.0%

37.4%

1.6%





3,148


2,623

20.0%

20.0%

0.0%


OPSUMIT



















US


279


185

52.1%

52.1%

-





1,008


766

31.7%

31.7%

-


Intl


173


143

21.2%

16.9%

4.3%





631


562

12.3%

12.3%

0.0%


WW


452


326

38.6%

36.7%

1.9%





1,639


1,327

23.5%

23.5%

0.0%


UPTRAVI



















US


263


178

48.2%

48.2%

-





955


714

33.8%

33.8%

-


Intl


38


30

25.5%

20.1%

5.4%





138


105

30.9%

30.5%

0.4%


WW


301


208

44.9%

44.1%

0.8%





1,093


819

33.5%

33.4%

0.1%


OTHER PULMONARY HYPERTENSION



















US


49


26

84.9%

84.9%

-





169


205

-17.6%

-17.6%

-


Intl


63


62

2.4%

-1.2%

3.6%





247


272

-9.2%

-9.4%

0.2%


WW


112


88

26.6%

24.1%

2.5%





416


476

-12.8%

-12.9%

0.1%


CARDIOVASCULAR / METABOLISM / OTHER



















US


935


930

0.6%

0.6%

-





3,509


3,734

-6.0%

-6.0%

-


Intl


317


327

-2.6%

-5.4%

2.8%





1,369


1,458

-6.1%

-4.8%

-1.3%


WW


1,253


1,256

-0.2%

-1.0%

0.8%





4,878


5,192

-6.0%

-5.7%

-0.3%


XARELTO



















US


629


609

3.1%

3.1%

-





2,345


2,313

1.4%

1.4%

-


Intl


-


-

-

-

-





-


-

-

-

-


WW


629


609

3.1%

3.1%

-





2,345


2,313

1.4%

1.4%

-


INVOKANA / INVOKAMET



















US


159


125

27.7%

27.7%

-





564


536

5.2%

5.2%

-


Intl


58


52

11.5%

8.9%

2.6%





231


199

16.3%

17.6%

-1.3%


WW


217


177

22.9%

22.1%

0.8%





795


735

8.2%

8.6%

-0.4%


PROCRIT / EPREX



















US


62


118

-46.9%

-46.9%

-





277


505

-45.1%

-45.1%

-


Intl


66


65

2.0%

-1.1%

3.1%





274


285

-3.8%

-3.6%

-0.2%


WW


129


183

-29.5%

-30.6%

1.1%





552


790

-30.2%

-30.1%

-0.1%


OTHER



















US


85


78

9.4%

9.4%

-





323


380

-15.1%

-15.1%

-


Intl


194


209

-7.6%

-10.3%

2.7%





864


974

-11.3%

-9.7%

-1.6%


WW


278


286

-3.0%

-5.0%

2.0%





1,186


1,353

-12.4%

-11.2%

-1.2%


TOTAL PHARMACEUTICAL



















US


7,116


6,169

15.3%

15.3%

-





25,735


23,874

7.8%

7.8%

-


Intl


5,152


4,379

17.7%

13.5%

4.2%





19,837


18,324

8.3%

8.8%

-0.5%


WW


$     12,268


10,548

16.3%

14.6%

1.7%





$      45,572


42,198

8.0%

8.2%

-0.2%





















See footnotes at end of schedule



















































REPORTED SALES vs. PRIOR PERIOD ($MM)




REPORTED SALES vs. PRIOR PERIOD ($MM)



FOURTH QUARTER




TWELVE MONTHS




% Change





% Change


MEDICAL DEVICES SEGMENT (2,5)


2020


2019

Reported

Operational (1)

Currency





2020


2019

Reported

Operational (1)

Currency





















INTERVENTIONAL SOLUTIONS



















US


$          433


377

14.8%

14.8%

-





1,452


1,443

0.6%

0.6%

-


Intl


460


398

15.7%

10.8%

4.9%





1,594


1,554

2.6%

2.0%

0.6%


WW


893


774

15.3%

12.8%

2.5%





3,046


2,997

1.6%

1.3%

0.3%


ORTHOPAEDICS



















US


1,352


1,369

-1.3%

-1.3%

-





4,779


5,319

-10.2%

-10.2%

-


Intl


839


904

-7.3%

-11.3%

4.0%





2,984


3,520

-15.2%

-15.4%

0.2%


WW


2,191


2,273

-3.7%

-5.3%

1.6%





7,763


8,839

-12.2%

-12.3%

0.1%


HIPS



















US


229


230

-0.7%

-0.7%

-





793


863

-8.2%

-8.2%

-


Intl


143


147

-2.2%

-5.8%

3.6%





487


575

-15.3%

-15.1%

-0.2%


WW


372


377

-1.3%

-2.7%

1.4%





1,280


1,438

-11.0%

-11.0%

0.0%


KNEES



















US


216


239

-9.5%

-9.5%

-





743


889

-16.4%

-16.4%

-


Intl


129


156

-17.2%

-20.6%

3.4%





427


591

-27.8%

-28.0%

0.2%


WW


345


395

-12.5%

-13.9%

1.4%





1,170


1,480

-21.0%

-21.1%

0.1%


TRAUMA



















US


454


413

10.0%

10.0%

-





1,648


1,652

-0.2%

-0.2%

-


Intl


268


273

-2.0%

-6.2%

4.2%





966


1,068

-9.6%

-9.7%

0.1%


WW


722


686

5.2%

3.6%

1.6%





2,614


2,720

-3.9%

-3.9%

0.0%


SPINE, SPORTS & OTHER (7)



















US


453


488

-7.1%

-7.1%

-





1,595


1,915

-16.7%

-16.7%

-


Intl


299


329

-9.2%

-13.6%

4.4%





1,104


1,286

-14.1%

-14.6%

0.5%


WW


752


817

-7.9%

-9.7%

1.8%





2,699


3,201

-15.7%

-15.9%

0.2%


SURGERY



















US


1,002


961

4.3%

4.3%

-





3,249


3,828

-15.1%

-15.1%

-


Intl


1,427


1,481

-3.7%

-5.9%

2.2%





4,983


5,673

-12.2%

-11.2%

-1.0%


WW


2,429


2,442

-0.5%

-1.9%

1.4%





8,232


9,501

-13.4%

-12.8%

-0.6%


ADVANCED



















US


456


428

6.5%

6.5%

-





1,535


1,637

-6.2%

-6.2%

-


Intl


660


647

2.1%

-0.9%

3.0%





2,304


2,458

-6.2%

-5.6%

-0.6%


WW


1,116


1,076

3.8%

2.0%

1.8%





3,839


4,095

-6.2%

-5.8%

-0.4%


GENERAL



















US


546


534

2.5%

2.5%

-





1,714


2,192

-21.8%

-21.8%

-


Intl


767


834

-8.1%

-9.8%

1.7%





2,679


3,215

-16.7%

-15.5%

-1.2%


WW


1,312


1,366

-4.0%

-5.0%

1.0%





4,392


5,406

-18.8%

-18.0%

-0.8%


VISION



















US


397


428

-7.3%

-7.3%

-





1,557


1,794

-13.2%

-13.2%

-


Intl


679


713

-4.7%

-6.2%

1.5%





2,362


2,830

-16.5%

-16.2%

-0.3%


WW


1,076


1,141

-5.7%

-6.6%

0.9%





3,919


4,624

-15.2%

-15.1%

-0.1%


CONTACT LENSES / OTHER



















US


289


311

-7.4%

-7.4%

-





1,213


1,304

-7.0%

-7.0%

-


Intl


507


522

-2.7%

-4.1%

1.4%





1,781


2,088

-14.7%

-14.4%

-0.3%


WW


796


833

-4.4%

-5.3%

0.9%





2,994


3,392

-11.7%

-11.5%

-0.2%


SURGICAL



















US


108


117

-7.1%

-7.1%

-





344


490

-29.7%

-29.7%

-


Intl


172


191

-10.3%

-12.0%

1.7%





581


742

-21.7%

-21.5%

-0.2%


WW


280


309

-9.1%

-10.1%

1.0%





925


1,232

-24.9%

-24.7%

-0.2%





















TOTAL MEDICAL DEVICES



















US


3,184


3,135

1.5%

1.5%

-





11,036


12,384

-10.9%

-10.9%

-


Intl


3,405


3,497

-2.6%

-5.5%

2.9%





11,923


13,579

-12.2%

-11.8%

-0.4%


WW


$       6,589


6,632

-0.7%

-2.2%

1.5%





$      22,959


25,963

-11.6%

-11.4%

-0.2%






















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


(6) Reported as U.S. sales

(1) Operational growth excludes the effect of translational currency


(7) Previously referred to as Spine & Other

(2) Unaudited



(3) Previously referred to as Consumer



(4) Previously referred to as Beauty



(5) Certain prior year amounts have been reclassified to conform to current year product disclosures

(PRNewsfoto/Johnson & Johnson)

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The Conversation (0)
Medtronic Affera pulsed field ablation technologies continue to demonstrate promising evidence for atrial fibrillation patients

Medtronic Affera pulsed field ablation technologies continue to demonstrate promising evidence for atrial fibrillation patients

  • One-year clinical trial data for the next-generation, investigational, Sphere-360™ single-shot PFA catheter show impressive safety, performance, and efficiency results for paroxysmal Afib
  • Dual-energy (RF/PF), focal Sphere-9™ catheter demonstrates efficacy for linear ablation in persistent AFib
  • Medtronic continues legacy of leadership in innovation, showcasing arrhythmia management portfolio at Heart Rhythm Society annual meeting

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced positive clinical outcomes from two studies in atrial fibrillation (AFib) patients treated with the Affera™ family of technologies, including the next-generation Sphere-360™ single-shot pulsed field ablation (PFA) catheter and the groundbreaking Sphere-9™ combination mapping and dual-energy focal PFA catheter. Data were presented in High Impact Science Sessions at the Heart Rhythm Society 2025 Annual Meeting in San Diego ; the Sphere-360 study was simultaneously published in the Heart Rhythm Journal .

(PRNewsfoto/Medtronic plc)

Sphere-360 Study Safety and Performance

Sphere-360 is an investigational, first-of-its-kind, single-shot PFA mapping and ablation catheter for treatment of paroxysmal atrial fibrillation (PAF). Results for Sphere-360 at one year, in a prospective, single-arm, multi-center trial performed in European centers, demonstrated freedom from arrhythmia recurrence in 88% of patients, with chronically durable pulmonary vein isolation (PVI) in 98% of targeted veins and no reported safety events in a sub-group treated with the most optimized waveform. The Sphere-360 catheter has a large, conformable lattice design that can be modified into various shapes, is seamlessly integrated with the Affera Mapping and Ablation System and utilizes an 8.5 Fr sheath – the smallest in any single-shot PFA technology.

"The Affera technology is a sophisticated ecosystem, including an advanced, intuitive mapping system and catheters that are seamlessly integrated to offer treatment options for different cardiac arrhythmias. It is encouraging to see the promising results for Sphere-360, which can easily create circumferential lesions without the need for catheter rotation," said Vivek Reddy , M.D., Director of Cardiac Arrhythmia Services for the Mount Sinai Health System in New York City . "The study results showed Sphere-360 has a promising safety and performance profile with zero serious adverse events observed. Upon approval, Sphere-360 will be a valuable addition to Medtronic's Affera system, which has been a game changer for Afib treatment and physician workflow."

Medtronic intends to begin its U.S. pivotal trial for the Sphere-360 catheter later this calendar year. Worldwide, Sphere-360 is currently investigational and not approved for sale or distribution.

Sphere-9 for Linear Ablation

Additionally, in a sub-analysis from the Sphere Per-AF IDE study , results demonstrated that the Sphere-9 catheter can be used safely and effectively to create linear lesions in persistent AF patients. Linear ablation is often used in conjunction with PVI to improve the chances of restoring a normal heart rhythm without recurrence in persistent AF patients. The Sphere Per-AF IDE study evaluated the safety, efficacy and efficiency of Affera and Sphere-9 in persistent AF and led to the FDA approval of Affera in October 2024 .

"True to our Medtronic mission for patients and legacy of innovation, we are delivering our best-in-class technologies to physicians and improving care for AFib patients, and we are not slowing down," said Rebecca Seidel , president of the Cardiac Ablation Solutions business at Medtronic, which is part of the Cardiovascular portfolio. "These results signify another step forward and energize us as we continue to earn and build our leadership position in electrophysiology every day."

Medtronic is the only company with two PFA offerings for physicians and patients. The PulseSelect™ Pulsed Field Ablation System offers physicians a safe, single-shot solution for pulmonary vein isolation (PVI) and is now available in more than 30 countries. The Affera system together with the Sphere-9 catheter enables physician treatment flexibility with its wide area focal design and 9mm lattice tip that can used with an 8.5Fr sheath. Affera is available in Europe , Australia and New Zealand , with global expansion ongoing.

AFib is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide. 1 Afib is a progressive disease, often beginning as paroxysmal AFib (presents intermittently) and progressing to persistent (lasts for more than 7+ days without stopping). As the disease progresses, the risk of serious complications including heart failure, stroke and risk of death increases 2-5 .

For more information on the Affera PFA system and the Sphere-9 catheter, visit Medtronic.com.

About Medtronic

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway , Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn .

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

References

  1. Roth GA, Mensah GA, Johnson CO et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021.
  2. Miyasaka Y, Barnes ME, Bailey KR, et al. Mortality trends in patients diagnosed with first atrial fibrillation: a 21-year community-based study. J Am Coll Cardiol 2007;49:986-92.
  3. Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J 2020.
  4. Wolf PA , Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983-8.
  5. Lubitz SA, Moser C, Sullivan L, et al. Atrial fibrillation patterns and risks of subsequent stroke, heart failure, or death in the community. J Am Heart Assoc 2013;2:e000126

Dr. Reddy is a paid consultant for Medtronic.

Contacts:
Leslie Williamson
Public Relations
+1-612-227-5099

Ryan Weispfenning
Investor Relations
+1-763-505-4626

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-affera-pulsed-field-ablation-technologies-continue-to-demonstrate-promising-evidence-for-atrial-fibrillation-patients-302439006.html

SOURCE Medtronic plc

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Medtronic Expand URO U.S. clinical trial meets safety and effectiveness primary endpoints for Hugo robotic-assisted surgery system

Medtronic Expand URO U.S. clinical trial meets safety and effectiveness primary endpoints for Hugo robotic-assisted surgery system

Largest multi-center prospective Investigational Device Exemption (IDE) study for multi-port robotic-assisted urologic surgery   in the U.S. presented as a late-breaker at the American Urologic Association annual meeting

Company confirms Hugo RAS system submission to the U.S. Food and Drug Administration

Medtronic (NYSE: MDT), a global leader in healthcare technology, today announced that the Expand URO Investigational Device Exemption (IDE) clinical study, the largest such study for robotic-assisted urologic surgery ever conducted, met both primary safety and effectiveness endpoints. The prospective, multi-center, single-arm IDE study included 137 patients who underwent urologic procedures using the Hugo™ robotic-assisted surgery (RAS) system.

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Medtronic receives FDA approval for smallest-diameter, lumenless defibrillation lead, the OmniaSecure lead and announces investigational clinical study results

Medtronic receives FDA approval for smallest-diameter, lumenless defibrillation lead, the OmniaSecure lead and announces investigational clinical study results

Adding to the Medtronic portfolio of catheter-based lead solutions, the novel OmniaSecure defibrillation lead allows for precise delivery and placement in the right ventricle

Heart Rhythm 2025: Late-breaking clinical study results evaluating the OmniaSecure lead for investigational use in the LBBAP location show high defibrillation success

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Medtronic advances Abbott CGM partnership with FDA submission of interoperable insulin pump

Medtronic advances Abbott CGM partnership with FDA submission of interoperable insulin pump

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced it has submitted 510(k) applications to the U.S. Food and Drug Administration (FDA) seeking clearance for an interoperable pump. FDA clearance of this pump would pave the way for system integration with a continuous glucose monitoring (CGM) sensor based on Abbott's most advanced CGM platform.

(PRNewsfoto/Medtronic plc)

The submissions included a 510(k) application for its MiniMed™ 780G pump as an alternate controller enabled (ACE) insulin pump and a separate 510(k) application for its SmartGuard™ algorithm as an interoperable automated glycemic controller (iAGC).

"We understand how meaningful these advancements are, and we're working with urgency to bring enhanced CGM options to our customers," said Que Dallara, EVP & president, Medtronic Diabetes. "This collaboration with Abbott marks an important step forward in providing innovative solutions and more choice for our customers."

This milestone follows the announcement last August that the companies will collaborate on an integrated system based on Abbott's most advanced CGM platform. Abbott will supply Medtronic with a CGM that will work exclusively with Medtronic smart dosing devices and software across both automated insulin delivery and smart multiple daily injections systems. These systems, including the Abbott CGM, will be sold exclusively by Medtronic.

More details will be shared when FDA clearance is secured.

About the Diabetes Business at Medtronic ( www.medtronicdiabetes.com )
Medtronic Diabetes is on a mission to alleviate the burden of diabetes by empowering individuals to live life on their terms, with the most advanced diabetes technology and always-on support when and how they need it. We've pioneered first-of-its-kind innovations for over 40 years and are committed to designing the future of diabetes management through next-generation sensors (CGM), intelligent dosing systems, and the power of data science and AI while always putting the customer experience at the forefront.

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway , Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn .

Any forward-looking statements, including, but not limited to, statements regarding the partnership between Medtronic and Abbott, strategic and other potential benefits of the partnership, Abbott's products and product candidates, and other statements about Medtronic managements' future expectations, beliefs, goals, plans or prospects, are subject to risks and uncertainties including, but not limited to, the ability to obtain regulatory approvals, and other risks and uncertainties such as those described in Medtronic's reports and other filings with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. Medtronic cautions investors not to place considerable reliance on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this document, and Medtronic undertakes no obligation to update or revise any of these statements except to the extent required by law.

Contacts:
Janet Cho
Public Relations
+1-818-403-7028

Ryan Weispfenning
Investor Relations
+1-763-505-4626

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-advances-abbott-cgm-partnership-with-fda-submission-of-interoperable-insulin-pump-302437337.html

SOURCE Medtronic plc

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Orchestra BioMed Announces AVIM Therapy-Focused Satellite Symposium at HRS 2025 Annual Meeting

Orchestra BioMed Announces AVIM Therapy-Focused Satellite Symposium at HRS 2025 Annual Meeting

  • FDA recently granted Breakthrough Device Designation to AVIM therapy for use in patients with uncontrolled hypertension at increased cardiovascular risk
  • HRS Satellite Symposium will feature leading experts in electrophysiology, hypertension management and heart failure
  • Presentations will detail clinical results from prior studies demonstrating AVIM therapy's ability to immediately, substantially and persistently reduce systolic blood pressure, as well as improve cardiac function
  • Symposium will also feature presentation on the BACKBEAT global pivotal study Orchestra BioMed is currently enrolling in strategic collaboration with Medtronic, plc (NYSE: MDT)

Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, "Orchestra BioMed" or the "Company"), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced it will host an industry-sponsored satellite symposium at the Heart Rhythm Society ("HRS") 2025 Annual Meeting, taking place April 24–27, 2025, in San Diego, California featuring recent advancements in the Company's atrioventricular interval modulation ("AVIM") therapy program. The April 25 th 6:45 am PT symposium titled " The Future of Cardiac Pacing: Unlocking the Potential of Atrioventricular Interval Modulation (AVIM) Therapy " will convene leading electrophysiologists, hypertension and heart failure specialists to discuss the unmet need in hypertension, AVIM therapy mechanism of action, and growing body of clinical evidence supporting this novel therapy for the treatment of patients with uncontrolled hypertension who have increased cardiovascular risk with or without an indication for a pacemaker.

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Orchestra BioMed Receives FDA Breakthrough Device Designation for AVIM Therapy

Orchestra BioMed Receives FDA Breakthrough Device Designation for AVIM Therapy

  • Breakthrough Device Designation ("BDD") applies to an estimated U.S. population of over 7.7 million patients with uncontrolled hypertension and increased cardiovascular risk
  • BDD also encompasses pacemaker-indicated patients with uncontrolled hypertension who are the focus of the BACKBEAT global pivotal study Orchestra BioMed is currently enrolling in strategic collaboration with Medtronic, plc (NYSE: MDT)
  • BDD status provides accelerated FDA engagement and reviews for AVIM therapy; it also supports potential pathways to secure higher reimbursement for AVIM-enabled devices in the future

Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) ("Orchestra BioMed" or the "Company"), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Device Designation ("BDD") for atrioventricular interval modulation ("AVIM") therapy.

Specifically, the BDD is for an implantable system (i.e., a pacemaker) to deliver AVIM therapy using conduction system pacing to reduce blood pressure in patients with increased ten-year atherosclerotic cardiovascular disease ("ASCVD") risk, preserved left ventricular systolic function, and uncontrolled hypertension, despite the use of anti-hypertensive medications or in patients who may have intolerance to anti-hypertensive medications. Orchestra BioMed estimates that there are over 7.7 million patients in the U.S. that meet the criteria for the BDD for AVIM therapy. AVIM therapy is currently being evaluated under an FDA investigational device exemption ("IDE") in the BACKBEAT global pivotal study which is being conducted by Orchestra BioMed in collaboration with Medtronic. The BACKBEAT pivotal study is enrolling pacemaker-indicated patients with uncontrolled hypertension despite the use of anti-hypertensive medication, a key subpopulation under the BDD for which Orchestra BioMed believes AVIM therapy may offer optimal clinical benefit.

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