Johnson & Johnson Reports 2020 Third-Quarter Results

- Johnson & Johnson (NYSE: JNJ) today announced results for third-quarter 2020.  "Our third-quarter results reflect solid performance and positive trends across Johnson & Johnson, powered by better-than-expected procedure recovery in Medical Devices, growth in Consumer Health, and continued strength in Pharmaceuticals," said Alex Gorsky Chairman and Chief Executive Officer. "I am proud of the relentless passion and Credo-led commitment to patients and customers that our colleagues around the world continue to demonstrate as we boldly fight the COVID-19 pandemic. Our world-class R&D team is working tirelessly to advance the Phase 3 trials of our COVID-19 vaccine and to uphold the highest standards of transparency, safety and efficacy; while other dedicated teams provide ongoing support to hospitals and patients as they return to sites of care, and ensure patients and consumers have the medicines and products they need. This resilient mindset, combined with our strategic capabilities and execution excellence, increase our optimism for continued recovery in 2020 and strong momentum entering into 2021."

OVERALL FINANCIAL RESULTS   :


THIRD QUARTER


($ in Millions, except EPS)

2020

2019

%  Change

Reported Sales

$ 21,082

$ 20,729

1.7%

Net Earnings

3,554

1,753

102.7%

EPS (diluted)

$      1.33

$      0.66

101.5%





Non-GAAP*

THIRD QUARTER


($ in Millions, except EPS)

2020

2019

%  Change

Operational Sales 1,2

N/A

N/A

1.7%

Adjusted Operational Sales 1,3

N/A

N/A

2.0%

Adjusted Net Earnings 1,4

5,868

5,672

3.5%

Adjusted EPS (diluted) 1,4

$      2.20

$      2.12

3.8%


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:


THIRD QUARTER

%  Change


($ in Millions) 1


2020
  2


2019
  2


Reported
  2


Operational
  1,2


Currency
  2

Adjusted
Operational 1,3

U.S.

$ 11,086

$ 10,791

2.7%

2.7%

-

2.8

International

9,996

9,938

0.6%

0.6%

0.0

1.1

Worldwide

$ 21,082

$ 20,729

1.7%

1.7%

0.0

2.0


1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules

2 Excludes the impact of translational currency

3 Excludes the net impact of acquisitions and divestitures and translational currency

Note: values may have been rounded

SEGMENT SALES RESULTS:


THIRD QUARTER

%  Change


($ in Millions) 1


2020
  1


2019
  1


Reported
  2


Operational
  1,2


Currency
  1

Adjusted
Operational 1,3

Consumer Health

$       3,514

$       3,469

1.3%

3.0

(1.7)

3.1

Pharmaceutical

11,418

10,877

5.0%

4.6

0.4

4.7

Medical Devices

6,150

6,383

(3.6)%

(3.9)

0.3

(3.3)

Worldwide

$     21,082

$     20,729

1.7%

1.7

0.0

2.0


1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules

2 Excludes the impact of translational currency

3 Excludes the net impact of acquisitions and divestitures and translational currency

Note: values may have been rounded

SEGMENT COMMENTARY:

Consumer Health
Consumer Health worldwide operational sales, excluding the net impact of acquisitions and divestitures, increased by 3.1%*, inclusive of the net negative impact of COVID-19 primarily in international over-the-counter products.  Sales growth was driven by U.S. growth in over-the-counter products including TYLENOL analgesics and digestive health products; LISTERINE mouthwash in oral care products; OGX in skin health/beauty products; and wound care products, primarily BAND-AID® Brand Adhesive Bandages.

Pharmaceutical
Pharmaceutical worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 4.7%* driven by DARZALEX (daratumumab), for the treatment of multiple myeloma, STELARA (ustekinumab), a biologic for the treatment of a number of immune-mediated inflammatory diseases, IMBRUVICA (ibrutinib), an oral, once-daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer, 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, UPTRAVI (selexipag), an oral prostacyclin receptor agonist used to treat pulmonary arterial hypertension and reduce hospitalization, and ERLEADA (apalutamide), a next-generation androgen receptor inhibitor for the treatment of patients with prostate cancer. 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, and ZYTIGA (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic castration-resistant prostate cancer.

Medical Devices
Medical Devices worldwide operational sales, excluding the net impact of acquisitions and divestitures, declined by 3.3%*.  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. Results reflect market recovery versus the second quarter. The decline was partially offset by growth in the Interventional Solutions business led by electrophysiology products.

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

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)


1 Subsequent to the quarter

FULL-YEAR 2020 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.

The estimated impact of the COVID-19 pandemic is included in the guidance below.


October 2020

July 2020




($ in Billions, except EPS)



Adjusted Operational Sales 1,2

Change vs. Prior Year

0.5% – 1.5%

(0.8%) – 1.0%

Operational Sales 2

Change vs. Prior Year

$82.0 to $82.8

0.0% – 1.0%

$81.0 to $82.5

(1.3%) – 0.5%

Estimated Reported Sales 3

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%)


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: October 2020 = $1.14 Euro Average Rate: July 2020 = $1.12 (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)

THIRD QUARTER


NINE 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.

$   1,556


1,394


11.6

%

11.6


-


$   4,853


4,369


11.1

%

11.1


-

International

1,958


2,075


(5.6)


(2.7)


(2.9)


5,582


5,962


(6.4)


(2.2)


(4.2)


3,514


3,469


1.3


3.0


(1.7)


10,435


10,331


1.0


3.4


(2.4)





















Pharmaceutical




















U.S.

6,438


6,340


1.5


1.5


-


18,619


17,705


5.2


5.2


-

International

4,980


4,537


9.7


8.8


0.9


14,685


13,945


5.3


7.4


(2.1)


11,418


10,877


5.0


4.6


0.4


33,304


31,650


5.2


6.1


(0.9)





















Medical Devices




















U.S.

3,092


3,057


1.2


1.2


-


7,852


9,249


(15.1)


(15.1)


-

International

3,058


3,326


(8.1)


(8.5)


0.4


8,518


10,082


(15.5)


(14.1)


(1.4)


6,150


6,383


(3.6)


(3.9)


0.3


16,370


19,331


(15.3)


(14.6)


(0.7)





















U.S.

11,086


10,791


2.7


2.7


-


31,324


31,323


0.0


0.0


-

International

9,996


9,938


0.6


0.6


0.0


28,785


29,989


(4.0)


(1.7)


(2.3)

Worldwide

$ 21,082


20,729


1.7


1.7


0.0


$ 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


NINE MONTHS






Percent Change






Percent Change


2020


2019


Total


Operations


Currency


2020


2019


Total


Operations


Currency

Sales to customers by




















geographic area








































U.S.

$ 11,086


10,791


2.7

%

2.7


-


$ 31,324


31,323


0.0

%

0.0


-





















Europe

4,819


4,461


8.0


4.6


3.4


13,709


13,803


(0.7)


0.1


(0.8)

Western Hemisphere excluding U.S.

1,296


1,488


(12.9)


(1.2)


(11.7)


3,931


4,446


(11.6)


(0.4)


(11.2)

Asia-Pacific, Africa

3,881


3,989


(2.7)


(3.2)


0.5


11,145


11,740


(5.1)


(4.3)


(0.8)

International

9,996


9,938


0.6


0.6


0.0


28,785


29,989


(4.0)


(1.7)


(2.3)





















Worldwide

$ 21,082


20,729


1.7

%

1.7


0.0


$ 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)










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.

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)










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.

Johnson & Johnson and Subsidiaries

Reconciliation of Non-GAAP Financial Measures










Third Quarter


Nine Months Ended

(Dollars in Millions Except Per Share Data)

2020


2019


2020


2019

Net Earnings, after tax- as reported

$3,554


$1,753


$12,976


$11,109









Pre-tax Adjustments








Intangible Asset Amortization expense

1,181


1,138


3,426


3,386

Litigation expense, net

1,477


4,000


2,210


4,832

IPR&D

138


-


144


890

Restructuring related

130


128


363


360

Acquisition and Integration related ¹

(154)


107


(1,087)


229

Unrealized (gains)/losses on securities

32


89


(174)


(217)

Medical Device Regulation 2

38


-


89


-

Other

3


7


6


7









Tax Adjustments








Tax impact on special item adjustments 3

(482)


(1,159)


(1,002)


(1,922)

Tax legislation and related impacts

(49)


(391)


(483)


(391)

Adjusted Net Earnings, after tax

$5,868


$5,672


$16,468


$18,283

Average shares outstanding (Diluted)

2,669.3


2,669.9


2,670.8


2,688.1

Adjusted net earnings per share (Diluted)

$2.20


$2.12


$6.17


$6.80

Operational adjusted net earnings per share (Diluted)

$2.17




$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

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

Johnson & Johnson and Subsidiaries

Reconciliation of Non-GAAP Financial Measure


Adjusted Operational Sales Growth

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


REPORTED SALES vs. PRIOR PERIOD ($MM)




REPORTED SALES vs. PRIOR PERIOD ($MM)


THIRD QUARTER




NINE MONTHS



% Change





% Change



2020


2019

Reported

Operational (1)

Currency





2020


2019

Reported

Operational (1)

Currency

CONSUMER HEALTH SEGMENT (2,3)


















OTC


















US


$         601


477

26.0%

26.0%

-





$        1,917


1,468

30.6%

30.6%

-

Intl


541


621

-12.9%

-12.9%

0.0%





1,722


1,781

-3.3%

-0.6%

-2.7%

WW


1,142


1,098

4.0%

4.0%

0.0%





3,639


3,249

12.0%

13.5%

-1.5%

SKIN HEALTH / BEAUTY (4)


















US


572


559

2.4%

2.4%

-





1,767


1,810

-2.4%

-2.4%

-

Intl


577


592

-2.7%

-0.5%

-2.2%





1,506


1,633

-7.8%

-4.9%

-2.9%

WW


1,149


1,151

-0.2%

0.9%

-1.1%





3,273


3,443

-5.0%

-3.6%

-1.4%

ORAL CARE


















US


164


156

5.5%

5.5%

-





510


462

10.4%

10.4%

-

Intl


248


223

10.7%

14.4%

-3.7%





694


673

3.0%

7.9%

-4.9%

WW


412


379

8.5%

10.8%

-2.3%





1,204


1,135

6.0%

8.9%

-2.9%

BABY CARE


















US


91


91

-1.0%

-1.0%

-





279


277

0.5%

0.5%

-

Intl


302


326

-7.2%

-0.6%

-6.6%





831


977

-14.9%

-8.6%

-6.3%

WW


393


417

-5.9%

-0.7%

-5.2%





1,110


1,254

-11.5%

-6.6%

-4.9%

WOMEN'S HEALTH


















US


3


3

-6.9%

-6.9%

-





10


9

7.3%

7.3%

-

Intl


227


252

-9.6%

-4.0%

-5.6%





654


724

-9.6%

-2.8%

-6.8%

WW


230


255

-9.6%

-4.1%

-5.5%





664


733

-9.4%

-2.7%

-6.7%

WOUND CARE / OTHER


















US


125


109

15.2%

15.2%

-





370


343

8.0%

8.0%

-

Intl


64


59

7.4%

10.3%

-2.9%





175


173

1.3%

5.4%

-4.1%

WW


189


168

12.5%

13.5%

-1.0%





545


516

5.8%

7.2%

-1.4%



















TOTAL CONSUMER HEALTH


















US


1,556


1,394

11.6%

11.6%

-





4,853


4,369

11.1%

11.1%

-

Intl


1,958


2,075

-5.6%

-2.7%

-2.9%





5,582


5,962

-6.4%

-2.2%

-4.2%

WW


$      3,514


3,469

1.3%

3.0%

-1.7%





$      10,435


10,331

1.0%

3.4%

-2.4%





































See footnotes at end of schedule







































































REPORTED SALES vs. PRIOR PERIOD ($MM)




REPORTED SALES vs. PRIOR PERIOD ($MM)


THIRD QUARTER




NINE MONTHS




% Change





% Change

PHARMACEUTICAL SEGMENT (2,5)


2020


2019

Reported

Operational (1)

Currency





2020


2019

Reported

Operational (1)

Currency



















IMMUNOLOGY


















US


$      2,558


2,582

-0.9%

-0.9%

-





$        7,330


7,124

2.9%

2.9%

-

Intl


1,230


1,129

9.0%

8.4%

0.6%





3,619


3,304

9.5%

11.9%

-2.4%

WW


3,789


3,711

2.1%

1.9%

0.2%





10,950


10,428

5.0%

5.7%

-0.7%

REMICADE


















US


634


749

-15.4%

-15.4%

-





1,852


2,324

-20.3%

-20.3%

-

US Exports (6)


78


88

-11.3%

-11.3%

-





321


226

42.1%

42.1%

-

Intl


209


299

-30.1%

-28.0%

-2.1%





673


795

-15.3%

-11.6%

-3.7%

WW


921


1,136

-18.9%

-18.4%

-0.5%





2,846


3,345

-14.9%

-14.0%

-0.9%

SIMPONI / SIMPONI ARIA


















US


312


313

-0.4%

-0.4%

-





840


857

-2.0%

-2.0%

-

Intl


280


273

2.4%

2.2%

0.2%





827


816

1.3%

3.9%

-2.6%

WW


592


586

0.9%

0.8%

0.1%





1,667


1,673

-0.4%

0.9%

-1.3%

STELARA


















US


1,313


1,212

8.4%

8.4%

-





3,668


3,152

16.4%

16.4%

-

Intl


634


487

30.3%

28.1%

2.2%





1,795


1,509

19.0%

20.6%

-1.6%

WW


1,947


1,698

14.7%

14.0%

0.7%





5,463


4,661

17.2%

17.7%

-0.5%

TREMFYA


















US


222


221

0.4%

0.4%

-





650


565

15.0%

15.0%

-

Intl


105


69

54.4%

50.4%

4.0%





316


177

78.7%

79.1%

-0.4%

WW


327


290

13.1%

12.2%

0.9%





965


742

30.2%

30.3%

-0.1%

OTHER IMMUNOLOGY


















US


-


-

-

-

-





-


-

-

-

-

Intl


3


2

35.6%

44.6%

-9.0%





9


8

12.4%

19.1%

-6.7%

WW


3


2

35.6%

44.6%

-9.0%





9


8

12.4%

19.1%

-6.7%

INFECTIOUS DISEASES


















US


413


418

-1.1%

-1.1%

-





1,265


1,162

8.9%

8.9%

-

Intl


451


421

7.0%

6.3%

0.7%





1,397


1,385

0.9%

3.8%

-2.9%

WW


864


839

3.0%

2.6%

0.4%





2,662


2,547

4.5%

6.1%

-1.6%

EDURANT / rilpivirine


















US


11


12

-12.0%

-12.0%

-





33


36

-8.6%

-8.6%

-

Intl


226


206

9.3%

5.0%

4.3%





684


603

13.3%

13.8%

-0.5%

WW


236


218

8.1%

4.1%

4.0%





716


639

12.1%

12.6%

-0.5%

PREZISTA / PREZCOBIX / REZOLSTA / SYMTUZA


















US


379


373

1.5%

1.5%

-





1,154


1,032

11.8%

11.8%

-

Intl


147


135

9.1%

12.1%

-3.0%





461


534

-13.7%

-8.8%

-4.9%

WW


526


508

3.5%

4.3%

-0.8%





1,615


1,566

3.1%

4.8%

-1.7%

OTHER INFECTIOUS DISEASES


















US


24


33

-26.6%

-26.6%

-





79


94

-16.6%

-16.6%

-

Intl


78


80

-2.3%

-0.4%

-1.9%





252


248

1.8%

6.3%

-4.5%

WW


102


113

-9.4%

-8.1%

-1.3%





331


342

-3.2%

0.0%

-3.2%






































REPORTED SALES vs. PRIOR PERIOD ($MM)




REPORTED SALES vs. PRIOR PERIOD ($MM)


THIRD QUARTER




NINE MONTHS



% Change





% Change



2020


2019

Reported

Operational (1)

Currency





2020


2019

Reported

Operational (1)

Currency

NEUROSCIENCE


















US


759


785

-3.5%

-3.5%

-





2,285


2,172

5.2%

5.2%

-

Intl


846


810

4.5%

4.1%

0.4%





2,565


2,590

-1.0%

0.9%

-1.9%

WW


1,605


1,595

0.6%

0.4%

0.2%





4,850


4,762

1.8%

2.9%

-1.1%

CONCERTA / Methylphenidate


















US


43


84

-49.2%

-49.2%

-





150


196

-23.6%

-23.6%

-

Intl


107


109

-2.0%

-1.7%

-0.3%





319


348

-8.2%

-6.4%

-1.8%

WW


149


193

-22.6%

-22.5%

-0.1%





469


544

-13.8%

-12.6%

-1.2%

INVEGA SUSTENNA / XEPLION /
INVEGA TRINZA / TREVICTA


















US


585


554

5.6%

5.6%

-





1,704


1,543

10.5%

10.5%

-

Intl


341


297

14.9%

12.6%

2.3%





983


916

7.3%

8.6%

-1.3%

WW


926


851

8.8%

8.0%

0.8%





2,688


2,459

9.3%

9.8%

-0.5%

RISPERDAL CONSTA


















US


70


79

-11.0%

-11.0%

-





220


237

-6.9%

-6.9%

-

Intl


81


89

-7.8%

-8.9%

1.1%





254


292

-12.7%

-11.0%

-1.7%

WW


152


167

-9.3%

-9.9%

0.6%





475


528

-10.1%

-9.2%

-0.9%

OTHER NEUROSCIENCE


















US


60


68

-11.3%

-11.3%

-





210


196

7.1%

7.1%

-

Intl


317


316

0.3%

1.7%

-1.4%





1,008


1,035

-2.6%

-0.1%

-2.5%

WW


377


384

-1.8%

-0.6%

-1.2%





1,218


1,231

-1.1%

1.1%

-2.2%

ONCOLOGY


















US


1,267


1,171

8.2%

8.2%

-





3,623


3,146

15.2%

15.2%

-

Intl


1,862


1,590

17.1%

15.5%

1.6%





5,310


4,830

9.9%

11.8%

-1.9%

WW


3,129


2,761

13.3%

12.4%

0.9%





8,933


7,976

12.0%

13.1%

-1.1%

DARZALEX


















US


585


402

46.0%

46.0%

-





1,540


1,123

37.2%

37.2%

-

Intl


514


363

41.5%

40.5%

1.0%





1,397


1,045

33.7%

36.7%

-3.0%

WW


1,099


765

43.8%

43.4%

0.4%





2,937


2,168

35.5%

37.0%

-1.5%

ERLEADA


















US


152


74

*

*

-





407


194

*

*

-

Intl


55


12

*

*

*





112


22

*

*

*

WW


206


86

*

*

*





519


216

*

*

*

IMBRUVICA


















US


450


447

0.7%

0.7%

-





1,329


1,163

14.2%

14.2%

-

Intl


581


475

22.5%

21.2%

1.3%





1,682


1,373

22.5%

25.2%

-2.7%

WW


1,031


921

11.9%

11.2%

0.7%





3,011


2,536

18.7%

20.2%

-1.5%

VELCADE


















US


-


-

-

-

-





-


-

-

-

-

Intl


105


149

-30.1%

-30.8%

0.7%





311


636

-51.2%

-50.7%

-0.5%

WW


105


149

-30.1%

-30.8%

0.7%





311


636

-51.2%

-50.7%

-0.5%

ZYTIGA / abiraterone acetate


















US


58


233

-75.2%

-75.2%

-





284


616

-53.9%

-53.9%

-

Intl


532


508

4.8%

2.2%

2.6%





1,564


1,502

4.1%

4.8%

-0.7%

WW


590


741

-20.4%

-22.1%

1.7%





1,848


2,118

-12.7%

-12.3%

-0.4%

OTHER ONCOLOGY


















US


21


17

35.3%

35.3%

-





63


51

25.8%

25.8%

-

Intl


76


83

-8.8%

-10.1%

1.3%





244


252

-3.1%

-1.1%

-2.0%

WW


98


100

-1.7%

-2.8%

1.1%





308


303

1.7%

3.3%

-1.6%

PULMONARY HYPERTENSION


















US


510


427

19.4%

19.4%

-





1,541


1,296

18.9%

18.9%

-

Intl


239


227

5.2%

3.7%

1.5%





742


704

5.3%

6.5%

-1.2%

WW


749


654

14.5%

13.9%

0.6%





2,283


2,000

14.1%

14.6%

-0.5%

OPSUMIT


















US


244


206

18.1%

18.1%

-





729


581

25.3%

25.3%

-

Intl


148


140

5.5%

3.9%

1.6%





458


419

9.3%

10.7%

-1.4%

WW


392


347

13.0%

12.3%

0.7%





1,187


1,001

18.6%

19.2%

-0.6%

UPTRAVI


















US


226


185

22.4%

22.4%

-





692


536

29.1%

29.1%

-

Intl


34


25

32.3%

28.9%

3.4%





100


75

33.1%

34.6%

-1.5%

WW


260


210

23.6%

23.2%

0.4%





792


611

29.6%

29.8%

-0.2%

OTHER PULMONARY HYPERTENSION


















US


40


36

11.5%

11.5%

-





121


179

-32.3%

-32.3%

-

Intl


57


61

-6.7%

-7.4%

0.7%





183


210

-12.7%

-11.9%

-0.8%

WW


97


96

0.1%

-0.3%

0.4%





304


388

-21.7%

-21.3%

-0.4%

CARDIOVASCULAR / METABOLISM / OTHER


















US


931


955

-2.6%

-2.6%

-





2,574


2,804

-8.2%

-8.2%

-

Intl


351


360

-2.7%

-2.4%

-0.3%





1,052


1,131

-7.1%

-4.6%

-2.5%

WW


1,281


1,316

-2.6%

-2.5%

-0.1%





3,625


3,936

-7.9%

-7.2%

-0.7%

XARELTO


















US


630


613

2.9%

2.9%

-





1,716


1,704

0.7%

0.7%

-

Intl


-


-

-

-

-





-


-

-

-

-

WW


630


613

2.9%

2.9%

-





1,716


1,704

0.7%

0.7%

-

INVOKANA / INVOKAMET


















US


156


125

24.7%

24.7%

-





405


411

-1.6%

-1.6%

-

Intl


68


55

24.7%

25.2%

-0.5%





173


147

18.0%

20.7%

-2.7%

WW


224


179

24.7%

24.9%

-0.2%





578


558

3.6%

4.3%

-0.7%

PROCRIT / EPREX


















US


69


126

-45.4%

-45.4%

-





215


387

-44.5%

-44.5%

-

Intl


63


72

-12.2%

-13.0%

0.8%





208


220

-5.5%

-4.3%

-1.2%

WW


132


198

-33.3%

-33.6%

0.3%





423


607

-30.4%

-29.9%

-0.5%

OTHER


















US


75


91

-17.9%

-17.9%

-





238


302

-21.4%

-21.4%

-

Intl


219


234

-6.2%

-5.5%

-0.7%





670


765

-12.3%

-9.5%

-2.8%

WW


294


325

-9.5%

-9.0%

-0.5%





908


1,067

-14.9%

-12.9%

-2.0%

TOTAL PHARMACEUTICAL


















US


6,438


6,340

1.5%

1.5%

-





18,619


17,705

5.2%

5.2%

-

Intl


4,980


4,537

9.7%

8.8%

0.9%





14,685


13,945

5.3%

7.4%

-2.1%

WW


$    11,418


10,877

5.0%

4.6%

0.4%





$      33,304


31,650

5.2%

6.1%

-0.9%



















See footnotes at end of schedule





































REPORTED SALES vs. PRIOR PERIOD ($MM)




REPORTED SALES vs. PRIOR PERIOD ($MM)


THIRD QUARTER




NINE MONTHS



% Change





% Change

MEDICAL DEVICES SEGMENT (2,5)


2020


2019

Reported

Operational (1)

Currency





2020


2019

Reported

Operational (1)

Currency



















INTERVENTIONAL SOLUTIONS


















US


399


357

11.8%

11.8%

-





1,019


1,066

-4.4%

-4.4%

-

Intl


437


382

14.0%

12.9%

1.1%





1,134


1,156

-2.0%

-1.0%

-1.0%

WW


836


741

12.9%

12.4%

0.5%





2,153


2,223

-3.1%

-2.7%

-0.4%

ORTHOPAEDICS


















US


1,308


1,301

0.6%

0.6%

-





3,427


3,950

-13.2%

-13.2%

-

Intl


774


837

-7.5%

-9.0%

1.5%





2,145


2,616

-18.0%

-16.9%

-1.1%

WW


2,083


2,138

-2.6%

-3.1%

0.5%





5,572


6,566

-15.1%

-14.7%

-0.4%

HIPS


















US


221


204

8.7%

8.7%

-





564


633

-10.9%

-10.9%

-

Intl


124


133

-7.2%

-8.4%

1.2%





344


428

-19.8%

-18.3%

-1.5%

WW


345


336

2.4%

1.9%

0.5%





908


1,061

-14.5%

-13.9%

-0.6%

KNEES


















US


205


209

-1.9%

-1.9%

-





527


650

-19.0%

-19.0%

-

Intl


102


136

-24.8%

-26.4%

1.6%





298


435

-31.5%

-30.7%

-0.8%

WW


308


344

-10.9%

-11.6%

0.7%





825


1,085

-24.0%

-23.7%

-0.3%

TRAUMA


















US


433


415

4.2%

4.2%

-





1,194


1,239

-3.6%

-3.6%

-

Intl


253


262

-3.4%

-4.7%

1.3%





698


795

-12.2%

-10.9%

-1.3%

WW


685


677

1.3%

0.7%

0.6%





1,892


2,034

-7.0%

-6.5%

-0.5%

SPINE, SPORTS & OTHER (7)


















US


449


472

-4.9%

-4.9%

-





1,142


1,427

-20.0%

-20.0%

-

Intl


295


306

-3.4%

-5.0%

1.6%





805


957

-15.8%

-14.9%

-0.9%

WW


745


778

-4.3%

-5.0%

0.7%





1,947


2,384

-18.3%

-18.0%

-0.3%

SURGERY


















US


913


940

-3.0%

-3.0%

-





2,247


2,867

-21.7%

-21.7%

-

Intl


1,239


1,371

-9.6%

-9.5%

-0.1%





3,556


4,192

-15.2%

-13.1%

-2.1%

WW


2,152


2,311

-6.9%

-6.9%

0.0%





5,803


7,059

-17.8%

-16.6%

-1.2%

ADVANCED


















US


421


409

3.0%

3.0%

-





1,079


1,209

-10.7%

-10.7%

-

Intl


579


602

-3.9%

-4.1%

0.2%





1,644


1,811

-9.2%

-7.3%

-1.9%

WW


1,000


1,010

-1.1%

-1.2%

0.1%





2,723


3,019

-9.8%

-8.7%

-1.1%

GENERAL


















US


492


531

-7.6%

-7.6%

-





1,168


1,658

-29.6%

-29.6%

-

Intl


660


769

-14.1%

-13.8%

-0.3%





1,912


2,381

-19.7%

-17.5%

-2.2%

WW


1,152


1,301

-11.4%

-11.3%

-0.1%





3,080


4,040

-23.8%

-22.5%

-1.3%

VISION


















US


473


459

3.1%

3.1%

-





1,160


1,366

-15.1%

-15.1%

-

Intl


608


734

-17.2%

-17.4%

0.2%





1,683


2,117

-20.5%

-19.6%

-0.9%

WW


1,081


1,193

-9.4%

-9.5%

0.1%





2,843


3,483

-18.4%

-17.8%

-0.6%

CONTACT LENSES / OTHER


















US


375


339

10.9%

10.9%

-





924


993

-6.9%

-6.9%

-

Intl


455


555

-18.1%

-18.2%

0.1%





1,274


1,566

-18.7%

-17.8%

-0.9%

WW


830


893

-7.1%

-7.2%

0.1%





2,198


2,559

-14.1%

-13.6%

-0.5%

SURGICAL


















US


98


120

-18.9%

-18.9%

-





236


373

-36.8%

-36.8%

-

Intl


153


180

-14.6%

-14.8%

0.2%





409


551

-25.7%

-24.8%

-0.9%

WW


251


299

-16.3%

-16.4%

0.1%





645


923

-30.2%

-29.6%

-0.6%



















TOTAL MEDICAL DEVICES


















US


3,092


3,057

1.2%

1.2%

-





7,852


9,249

-15.1%

-15.1%

-

Intl


3,058


3,326

-8.1%

-8.5%

0.4%





8,518


10,082

-15.5%

-14.1%

-1.4%

WW


$      6,150


6,383

-3.6%

-3.9%

0.3%





$      16,370


19,331

-15.3%

-14.6%

-0.7%




















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)

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/johnson--johnson-reports-2020-third-quarter-results-301150947.html

SOURCE Johnson & Johnson

News Provided by PR Newswire via QuoteMedia

The Conversation (0)
Medtronic to announce financial results for its fourth quarter and full fiscal year 2025

Medtronic to announce financial results for its fourth quarter and full fiscal year 2025

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that it will report financial results for its fourth quarter and full fiscal year 2025 on Wednesday, May 21, 2025 . A news release will be issued at approximately 5:45 a.m. Central Daylight Time (CDT) and will be available at https:news.medtronic.com . The news release will include summary financial information for the company's fourth quarter and full fiscal year 2025, which ended on Friday, April 25, 2025 .

Medtronic will host a video webcast at 7:00 a.m. CDT on May 21, 2025 , to discuss results for its fourth quarter and full fiscal year 2025. The webcast can be accessed at https://investorrelations.medtronic.com .

News Provided by Canada Newswire via QuoteMedia

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New survey: 1 in 3 women have not talked to their doctor about heart health, the #1 killer of women

New survey: 1 in 3 women have not talked to their doctor about heart health, the #1 killer of women

Star Jones , award winning television personality & women's heart health advocate,   helps kick off heart health conversations this Mother's Day with the Medtronic 'Letter to My Mother' campaign

A new Medtronic-sponsored survey of women ages 30-50 reveals a significant gap in awareness and discussion around heart health among women and their mother-figures. Despite cardiovascular disease being the #1 killer of women in the U.S. many women are still unaware of the risk and the importance of heart health.

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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

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

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

News Provided by PR Newswire via QuoteMedia

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