Johnson & Johnson Reports Q3 2021 Results

- Johnson & Johnson (NYSE: JNJ) today announced results for third-quarter 2021. "Our third-quarter results demonstrate solid performance across Johnson & Johnson, driven by robust above-market results in Pharmaceuticals, ongoing recovery in Medical Devices, and strong growth in Consumer Health," said Alex Gorsky Chairman and Chief Executive Officer. "In the face of evolving marketplace dynamics resulting from the effects of COVID-19 and other global trends, we have continued to demonstrate the responsiveness and agility required to meet the needs of our stakeholders, while also successfully investing in a pipeline of innovation and key commercial platforms to drive our future growth. I am incredibly proud of our Company's transformative growth over the last decade. As I prepare to transition the role of CEO to Joaquin Duato in January, I want to extend my deepest gratitude to our colleagues around the globe who work tirelessly to deliver solutions to address the world's most urgent and unmet healthcare challenges."

OVERALL FINANCIAL RESULTS




Q3



($ in Millions, except EPS)

2021

2020

%  Change

Reported Sales

$       23,338

$       21,082

10.7%

Net Earnings

3,667

3,554

3.2%

EPS (diluted)

$           1.37

$           1.33

3.0%





Q3



Non-GAAP*   ($ in Millions, except EPS)

2021

2020

%  Change

Operational Sales 1,2



9.9%

Adjusted Operational Sales 1,3



10.6%

Adjusted Net Earnings 1,4

6,968

5,868

18.7%

Adjusted EPS (diluted) 1,4

$           2.60

$           2.20

18.2%



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


Q3


%  Change

($ in Millions)

2021

2020

Reported

Operational 1,2

Currency

Adjusted
Operational 1,3

U.S.

$      11,963

$      11,086

7.9%

7.9

-

8.0

International

11,375

9,996

13.8%

12.1

1.7

13.5

Worldwide

$      23,338

$      21,082

10.7%

9.9

0.8

10.6



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


Q3


%  Change

($ in Millions)

2021

2020

Reported

Operational 1,2

Currency

Adjusted
Operational 1,3

Consumer Health

$         3,700

$         3,514

5.3%

4.1

1.2

5.7

Pharmaceutical

12,994

11,418

13.8%

13.2

0.6

13.8

Medical Devices

6,644

6,150

8.0%

7.0

1.0

7.6

Worldwide

$       23,338

$      21,082

10.7%

9.9

0.8

10.6



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

THIRD QUARTER 2021 SEGMENT COMMENTARY:

Consumer Health
Consumer Health worldwide operational sales, excluding the net impact of acquisitions and divestitures, increased 5.7%* primarily driven by over-the-counter (OTC) products. Major contributors to growth were TYLENOL and MOTRIN analgesics, upper respiratory products, and digestive health in OTC, and AVEENO in Skin Health / Beauty.

Pharmaceutical
Pharmaceutical worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 13.8%* 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, TREMFYA (guselkumab), a biologic for the treatment of adults living with moderate to severe plaque psoriasis, and for adults with active psoriatic arthritis, ERLEADA (apalutamide), a next-generation androgen receptor inhibitor for the treatment of patients with prostate cancer, INVEGA SUSTENNA/XEPLION/INVEGA TRINZA/TREVICTA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults, and OPSUMIT (macitentan) an oral endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension to delay disease progression. Also contributing to growth was sales of the not-for-profit COVID-19 Vaccine (Ad26.COV2.S) for the treatment of the SARS-CoV-2 virus. This growth was partially offset by declines in U.S. sales of REMICADE (infliximab), a biologic approved for the treatment of a number of immune-mediated inflammatory diseases, and INVOKANA (canagliflozin) for the treatment of adults with type 2 diabetes.

Medical Devices
Medical Devices worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 7.6%*, driven by electrophysiology products in Interventional Solutions, wound closure products in General Surgery, surgical vision products and contact lenses in Vision, trauma, hips, and knees in Orthopaedics, and energy, endocutters, and biosurgicals in Advanced Surgery. Growth was partially offset by Spine, Sports & Other.

NOTABLE NEW ANNOUCEMENTS 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
Decisions

INVEGA HAFYERA (paliperidone palmitate) Receives FDA Approval For First and Only Twice-Yearly Treatment for Adults with Schizophrenia

(press release)

XARELTO (rivaroxaban) Plus Aspirin Receives FDA Approval For Expanded Peripheral Artery Disease (PAD) Indication to Include Patients After Lower-Extremity Revascularization (LER)

(press release)

UPTRAVI (selexipag) Receives FDA Approval For Intravenous Use in Adult Patients with Pulmonary Arterial Hypertension (PAH)

(press release)

Regulatory
Submissions

Johnson & Johnson Announces Submission of Emergency Use Authorization Amendment to the U.S. FDA to Support Booster of its Single-Shot COVID-19 Vaccine 1

(press release)

Janssen Submits Application Seeking U.S. FDA Approval of STELARA (ustekinumab) for the Treatment of Pediatric Patients With Juvenile Psoriatic Arthritis 1

(press release)

Other

Alex Gorsky to Transition Role of Chief Executive Officer of Johnson & Johnson to Joaquin Duato, Effective January 3, 2022

(press release)

Dr. Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer of Johnson & Johnson to Retire, Effective December 31, 2021 1

(press release)

Johnson & Johnson Announces Real-World Evidence and Phase 3 Data Confirming Strong and Long-Lasting Protection of Single-Shot COVID-19 Vaccine in the U.S.

(press release)

Johnson & Johnson Issues Statement on Nationwide Opioid Settlement Agreement

(press release)

DePuy Synthes Announces Introduction of the INHANCE Shoulder System, a First-to-Market, Fully Integrated Shoulder Arthroplasty System

(press release)

Janssen Announces Start of Phase 3 Trial for Investigational Respiratory Syncytial Virus (RSV) Vaccine in Older Adults

(press release)

Janssen Receives Positive CHMP Opinion for BYANNLI (six-monthly paliperidone palmitate) for the Maintenance Treatment of Schizophrenia in Adults

(press release)

Ethicon Announces ECHELON CIRCULAR Powered Stapler Associated with Major Reduction in Serious Complications Following Colorectal Surgery

(press release)

Johnson & Johnson Takes Steps to Equitably Resolve All Current and Future Talc Claims 1

(press release)

Janssen Receives Positive CHMP Opinion for RYBREVANT (amivantamab) for the Treatment of Patients with Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations After Failure of Platinum-Based Therapy 1

(press release)

Johnson & Johnson COVID-19 Vaccine Booster Shot Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee 1

(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.

($ in Billions, except EPS)

October 2021
(Base Business)

October 2021

(incl. COVID Vx)

July 2021

(Base Business)

July 2021

(incl. COVID Vx)

Adjusted Operational
Sales 1,2

Change vs. Prior Year

9.9% - 10.5%

12.9% - 13.5%

9.5% - 10.5%

12.5% - 13.5%

Operational Sales 2

Change vs. Prior Year

$90.3B – 90.8B

9.4% – 10.0%

$92.8 - $93.3B

12.4% – 13.0%

$90.0B - $90.8B

9.0% – 10.0%

$92.5B - $93.3B

12.0% – 13.0%

Estimated Reported
Sales 3

Change vs. Prior Year

$91.6B - $92.1B

10.9% – 11.5%

$94.1B - $94.6B

13.9% – 14.5%

$91.3B - $92.1B

10.5% – 11.5%

$93.8B - $94.6B

13.5% – 14.5%






Adjusted Operational EPS
(Diluted) 2,4

Change vs. Prior Year


$9.65 - $9.70

20.2% - 20.8%


$9.50 - $9.60

18.4% - 19.6%

Adjusted EPS (Diluted) 3,4

Change vs. Prior Year


$9.77 - $9.82

21.7% - 22.3%


$9.60 - $9.70

19.6% - 20.8%



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: July 2021 = $1.19 and October = $1.19 (Illustrative purposes only)

4

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


Note: % may have been rounded

Other modeling considerations will be provided on the webcast .

WEBCAST INFORMATION:
Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time . A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website . A replay and podcast will be available approximately two hours after the live webcast in the 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 January 3, 2021 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


2021


2020


Total


Operations


Currency


2021


2020


Total


Operations


Currency

Sales to customers by




















segment of business








































Consumer Health




















U.S.

$   1,625


1,556


4.5

%

4.5


-


$   4,987


4,853


2.8

%

2.8


-

International

2,075


1,958


5.9


3.7


2.2


5,991


5,582


7.3


3.5


3.8


3,700


3,514


5.3


4.1


1.2


10,978


10,435


5.2


3.1


2.1





















Pharmaceutical




















U.S.

7,221


6,438


12.2


12.2


-


20,536


18,619


10.3


10.3


-

International

5,773


4,980


15.9


14.6


1.3


17,256


14,685


17.5


12.5


5.0


12,994


11,418


13.8


13.2


0.6


37,792


33,304


13.5


11.3


2.2





















Medical Devices




















U.S.

3,117


3,092


0.8


0.8


-


9,470


7,852


20.6


20.6


-

International

3,527


3,058


15.4


13.3


2.1


10,731


8,518


26.0


20.5


5.5


6,644


6,150


8.0


7.0


1.0


20,201


16,370


23.4


20.5


2.9





















U.S.

11,963


11,086


7.9


7.9


-


34,993


31,324


11.7


11.7


-

International

11,375


9,996


13.8


12.1


1.7


33,978


28,785


18.0


13.1


4.9

Worldwide

$ 23,338


21,082


10.7

%

9.9


0.8


$ 68,971


60,109


14.7

%

12.4


2.3





















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


2021


2020


Total


Operations


Currency


2021


2020


Total


Operations


Currency

Sales to customers by




















geographic area








































U.S.

$ 11,963


11,086


7.9

%

7.9


-


$ 34,993


31,324


11.7

%

11.7


-





















Europe

5,587


4,819


15.9


14.6


1.3


16,669


13,709


21.6


15.3


6.3

Western Hemisphere excluding U.S.

1,500


1,296


15.7


13.4


2.3


4,291


3,931


9.2


8.1


1.1

Asia-Pacific, Africa

4,288


3,881


10.5


8.5


2.0


13,018


11,145


16.8


12.3


4.5

International

11,375


9,996


13.8


12.1


1.7


33,978


28,785


18.0


13.1


4.9





















Worldwide

$ 23,338


21,082


10.7

%

9.9


0.8


$ 68,971


60,109


14.7

%

12.4


2.3









































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












2021


2020


Percent




Percent




Percent


Increase


Amount


to Sales


Amount


to Sales


(Decrease)

Sales to customers

$ 23,338


100.0


$ 21,082


100.0


10.7

Cost of products sold

7,250


31.1


6,972


33.1


4.0

Gross Profit

16,088


68.9


14,110


66.9


14.0

Selling, marketing and administrative expenses

6,000


25.7


5,431


25.8


10.5

Research and development expense

3,422


14.7


2,840


13.5


20.5

In-process research and development

900


3.9


138


0.6



Interest (income) expense, net

7


0.0


32


0.1



Other (income) expense, net

1,850


7.9


1,200


5.7



Restructuring

60


0.2


68


0.3



Earnings before provision for taxes on income

3,849


16.5


4,401


20.9


(12.5)

Provision for taxes on income

182


0.8


847


4.0


(78.5)

Net earnings

$   3,667


15.7


$   3,554


16.9


3.2











Net earnings per share (Diluted)

$     1.37




$     1.33




3.0











Average shares outstanding (Diluted)

2,674.9




2,669.3















Effective tax rate

4.7

%



19.2

%














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










Earnings before provision for taxes on income

$   8,058


34.5


$   7,246


34.4


11.2

Net earnings

$   6,968


29.9


$   5,868


27.8


18.7

Net earnings per share (Diluted)

$     2.60




$     2.20




18.2

Effective tax rate

13.5

%



19.0

%














(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












2021


2020


Percent




Percent




Percent


Increase


Amount


to Sales


Amount


to Sales


(Decrease)

Sales to customers

$ 68,971


100.0


$ 60,109


100.0


14.7

Cost of products sold

21,900


31.8


20,613


34.3


6.2

Gross Profit

47,071


68.2


39,496


65.7


19.2

Selling, marketing and administrative expenses

17,505


25.4


15,627


26.0


12.0

Research and development expense

9,994


14.5


8,127


13.5


23.0

In-process research and development

900


1.3


144


0.3



Interest (income) expense, net

83


0.1


16


0.0



Other (income) expense, net

480


0.7


545


0.9



Restructuring

169


0.2


187


0.3



Earnings before provision for taxes on income

17,940


26.0


14,850


24.7


20.8

Provision for taxes on income

1,798


2.6


1,874


3.1


(4.1)

Net earnings

$ 16,142


23.4


$ 12,976


21.6


24.4











Net earnings per share (Diluted)

$     6.04




$     4.86




24.3











Average shares outstanding (Diluted)

2,674.6




2,670.8















Effective tax rate

10.0

%



12.6

%














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










Earnings before provision for taxes on income

$ 24,125


35.0


$ 19,827


33.0


21.7

Net earnings

$ 20,517


29.7


$ 16,468


27.4


24.6

Net earnings per share (Diluted)

$     7.67




$     6.17




24.3

Effective tax rate

15.0

%



16.9

%














(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)

2021


2020


2021


2020


Net Earnings, after tax- as reported

$3,667


$3,554


$16,142


$12,976











Pre-tax Adjustments









Intangible Asset Amortization expense

1,159


1,181


3,576


3,426


Litigation expense, net

2,077


1,477


2,054


2,210


IPR&D

900


138


900


144


Restructuring related

121


130


333


363


Acquisition, integration and divestiture related ¹

20


(154)


(504)


(1,087)


(Gains)/losses on securities

(127)


32


(335)


(174)


Medical Device Regulation

59


38


161


89


Other

-


3


-


6











Tax Adjustments









Tax impact on special item adjustments 2

(849)


(482)


(1,097)


(1,002)


Tax legislation and related impacts

(59)


(49)


(713)


(483)


Adjusted Net Earnings, after tax

$6,968


$5,868


$20,517


$16,468


Average shares outstanding (Diluted)

2,674.9


2,669.3


2,674.6


2,670.8


Adjusted net earnings per share (Diluted)

$2.60


$2.20


$7.67


$6.17


Operational adjusted net earnings per share (Diluted)

$2.56




$7.47













Notes:








1

Acquisition, integration and divestiture related for the nine months of 2021 primarily includes the gain on the divestiture of two Pharmaceutical brands outside of the U.S.  Acquisition, integration and divestiture related 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

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 2021 ACTUAL vs. 2020 ACTUAL


Segments












Consumer Health


Pharmaceutical


Medical Devices


Total










WW As Reported


5.3%


13.8%


8.0%


10.7%

U.S.


4.5%


12.2%


0.8%


7.9%

International


5.9%


15.9%


15.4%


13.8%










WW Currency


1.2


0.6


1.0


0.8

U.S.


-


-


-


-

International


2.2


1.3


2.1


1.7










WW Operational


4.1%


13.2%


7.0%


9.9%

U.S.


4.5%


12.2%


0.8%


7.9%

International


3.7%


14.6%


13.3%


12.1%










General Surgery









Advanced Sterilization Products






0.4


0.1

U.S.






0.0


0.0

International






0.8


0.2










Skin Health / Beauty









Dr. Ci Labo - Sedona


1.1






0.2

U.S.


0.0






0.0

International


2.0






0.4










All Other Acquisitions and Divestitures


0.5


0.6


0.2


0.4

U.S.


0.6


0.0


0.3


0.1

International


0.3


1.4


0.0


0.8










WW Adjusted Operational


5.7%


13.8%


7.6%


10.6%

U.S.


5.1%


12.2%


1.1%


8.0%

International


6.1%


16.0%


14.1%


13.5%










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 2021 ACTUAL vs. 2020 ACTUAL


Segments












Consumer Health


Pharmaceutical


Medical Devices


Total










WW As Reported


5.2%


13.5%


23.4%


14.7%

U.S.


2.8%


10.3%


20.6%


11.7%

International


7.3%


17.5%


26.0%


18.0%










WW Currency


2.1


2.2


2.9


2.3

U.S.


-


-


-


-

International


3.8


5.0


5.5


4.9










WW Operational


3.1%


11.3%


20.5%


12.4%

U.S.


2.8%


10.3%


20.6%


11.7%

International


3.5%


12.5%


20.5%


13.1%










General Surgery









Advanced Sterilization Products






0.6


0.2

U.S.






0.0


0.0

International






1.2


0.3










Skin Health / Beauty









Dr. Ci Labo - Sedona


0.5






0.1

U.S.


0.0






0.0

International


0.9






0.2










All Other Acquisitions and Divestitures


0.5


0.5


0.2


0.4

U.S.


0.5


(0.1)


0.4


0.1

International


0.3


1.3


0.0


0.7










WW Adjusted Operational


4.1%


11.8%


21.4%


13.1%

U.S.


3.3%


10.2%


21.0%


11.8%

International


4.7%


13.8%


21.7%


14.4%










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



2021


2020

Reported

Operational (1)

Currency



2021


2020

Reported

Operational (1)

Currency

CONSUMER HEALTH SEGMENT (2)
















OTC
















US


$             686


601

14.0%

14.0%

-



$          1,960


1,917

2.2%

2.2%

-

Intl


686


541

26.9%

22.8%

4.1%



1,894


1,722

10.0%

3.9%

6.1%

WW


1,372


1,142

20.1%

18.2%

1.9%



3,854


3,639

5.9%

3.0%

2.9%

SKIN HEALTH / BEAUTY
















US


569


572

-0.5%

-0.5%

-



1,862


1,767

5.4%

5.4%

-

Intl


555


577

-3.8%

-5.5%

1.7%



1,595


1,506

5.9%

2.1%

3.8%

WW


1,124


1,149

-2.2%

-3.0%

0.8%



3,457


3,273

5.6%

3.9%

1.7%

ORAL CARE
















US


150


164

-8.4%

-8.4%

-



478


510

-6.2%

-6.2%

-

Intl


248


248

0.1%

-1.8%

1.9%



762


694

9.9%

5.9%

4.0%

WW


398


412

-3.3%

-4.5%

1.2%



1,240


1,204

3.0%

0.8%

2.2%

BABY CARE
















US


95


91

5.2%

5.2%

-



288


279

3.3%

3.3%

-

Intl


296


302

-2.0%

-3.1%

1.1%



879


831

5.8%

4.6%

1.2%

WW


391


393

-0.3%

-1.2%

0.9%



1,167


1,110

5.2%

4.3%

0.9%

WOMEN'S HEALTH
















US


3


3

20.1%

20.1%

-



9


10

-5.7%

-5.7%

-

Intl


229


227

0.5%

0.6%

-0.1%



675


654

3.1%

2.3%

0.8%

WW


232


230

0.8%

0.8%

0.0%



684


664

3.0%

2.1%

0.9%

WOUND CARE / OTHER
















US


122


125

-2.6%

-2.6%

-



390


370

5.3%

5.3%

-

Intl


61


64

-5.2%

-9.0%

3.8%



186


175

5.8%

0.0%

5.8%

WW


182


189

-3.5%

-4.8%

1.3%



575


545

5.4%

3.6%

1.8%

















TOTAL CONSUMER HEALTH
















US


1,625


1,556

4.5%

4.5%

-



4,987


4,853

2.8%

2.8%

-

Intl


2,075


1,958

5.9%

3.7%

2.2%



5,991


5,582

7.3%

3.5%

3.8%

WW


$          3,700


3,514

5.3%

4.1%

1.2%



$        10,978


10,435

5.2%

3.1%

2.1%

































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 (2,3)


2021


2020

Reported

Operational (1)

Currency



2021


2020

Reported

Operational (1)

Currency

















IMMUNOLOGY
















US


$          2,771


2,558

8.3%

8.3%

-



$          7,932


7,330

8.2%

8.2%

-

Intl


1,480


1,230

20.3%

18.8%

1.5%



4,464


3,619

23.3%

17.6%

5.7%

WW


4,250


3,789

12.2%

11.7%

0.5%



12,395


10,950

13.2%

11.3%

1.9%

REMICADE
















US


480


634

-24.3%

-24.3%

-



1,508


1,852

-18.6%

-18.6%

-

US Exports (4)


47


78

-40.2%

-40.2%

-



197


321

-38.7%

-38.7%

-

Intl


234


209

12.2%

8.1%

4.1%



721


673

7.1%

1.4%

5.7%

WW


761


921

-17.4%

-18.3%

0.9%



2,426


2,846

-14.8%

-16.1%

1.3%

SIMPONI / SIMPONI ARIA
















US


295


312

-5.3%

-5.3%

-



840


840

0.0%

0.0%

-

Intl


276


280

-1.1%

-0.7%

-0.4%



877


827

6.1%

2.8%

3.3%

WW


571


592

-3.3%

-3.1%

-0.2%



1,717


1,667

3.0%

1.4%

1.6%

STELARA
















US


1,569


1,313

19.5%

19.5%

-



4,396


3,668

19.9%

19.9%

-

Intl


809


634

27.7%

26.3%

1.4%



2,404


1,795

33.9%

27.5%

6.4%

WW


2,378


1,947

22.2%

21.7%

0.5%



6,800


5,463

24.5%

22.4%

2.1%

TREMFYA
















US


376


222

69.7%

69.7%

-



975


650

50.1%

50.1%

-

Intl


161


105

52.5%

50.5%

2.0%



459


316

45.4%

38.0%

7.4%

WW


537


327

64.1%

63.5%

0.6%



1,434


965

48.5%

46.1%

2.4%

OTHER IMMUNOLOGY
















US


3


-

*

*

-



15


-

*

*

-

Intl


0


3

*

*

*



3


9

-68.6%

-70.8%

2.2%

WW


3


3

-26.4%

-27.5%

1.1%



18


9

91.6%

89.5%

2.1%

INFECTIOUS DISEASES
















US


679


413

64.3%

64.3%

-



1,635


1,265

29.2%

29.2%

-

Intl


709


451

57.2%

55.6%

1.6%



1,788


1,397

28.0%

23.2%

4.8%

WW


1,389


864

60.6%

59.8%

0.8%



3,424


2,662

28.6%

26.1%

2.5%

COVID-19 VACCINE
















US


270


-

*

*

-



421


-

*

*

-

Intl


233


-

*

*

-



346


-

*

*

-

WW


502


-

*

*

-



766


-

*

*

-

EDURANT / rilpivirine
















US


12


11

8.4%

8.4%

-



31


33

-4.8%

-4.8%

-

Intl


247


226

9.7%

8.7%

1.0%



733


684

7.2%

1.7%

5.5%

WW


259


236

9.6%

8.6%

1.0%



764


716

6.7%

1.4%

5.3%

PREZISTA / PREZCOBIX / REZOLSTA / SYMTUZA
















US


380


379

0.4%

0.4%

-



1,128


1,154

-2.2%

-2.2%

-

Intl


137


147

-7.1%

-8.8%

1.7%



440


461

-4.6%

-8.6%

4.0%

WW


517


526

-1.7%

-2.2%

0.5%



1,568


1,615

-2.9%

-4.1%

1.2%

OTHER INFECTIOUS DISEASES
















US


18


24

-26.0%

-26.0%

-



55


79

-29.6%

-29.6%

-

Intl


93


78

18.3%

15.2%

3.1%



270


252

6.9%

2.6%

4.3%

WW


110


102

7.8%

5.4%

2.4%



325


331

-1.8%

-5.0%

3.2%


REPORTED SALES vs. PRIOR PERIOD ($MM)


REPORTED SALES vs. PRIOR PERIOD ($MM)


THIRD QUARTER


NINE MONTHS






% Change






% Change



2021


2020

Reported

Operational (1)

Currency



2021


2020

Reported

Operational (1)

Currency

NEUROSCIENCE
















US


835


759

10.2%

10.2%

-



2,448


2,285

7.2%

7.2%

-

Intl


854


846

0.8%

-0.5%

1.3%



2,770


2,565

8.0%

4.1%

3.9%

WW


1,689


1,605

5.3%

4.6%

0.7%



5,218


4,850

7.6%

5.5%

2.1%

CONCERTA / Methylphenidate
















US


35


43

-19.5%

-19.5%

-



117


150

-22.1%

-22.1%

-

Intl


122


107

14.2%

12.5%

1.7%



372


319

16.4%

11.6%

4.8%

WW


157


149

4.5%

3.3%

1.2%



489


469

4.1%

0.8%

3.3%

INVEGA SUSTENNA / XEPLION /
INVEGA TRINZA / TREVICTA
















US


648


585

11.0%

11.0%

-



1,882


1,704

10.4%

10.4%

-

Intl


355


341

4.3%

3.2%

1.1%



1,111


983

13.0%

7.6%

5.4%

WW


1,004


926

8.5%

8.1%

0.4%



2,994


2,688

11.4%

9.4%

2.0%

RISPERDAL CONSTA
















US


71


70

1.3%

1.3%

-



210


220

-4.7%

-4.7%

-

Intl


69


81

-16.7%

-16.0%

-0.7%



242


254

-5.1%

-8.3%

3.2%

WW


140


152

-8.4%

-8.0%

-0.4%



452


475

-4.9%

-6.6%

1.7%

OTHER NEUROSCIENCE
















US


81


60

34.7%

34.7%

-



239


210

13.9%

13.9%

-

Intl


307


317

-2.9%

-4.8%

1.9%



1,045


1,008

3.7%

1.5%

2.2%

WW


388


377

3.1%

1.5%

1.6%



1,284


1,218

5.5%

3.6%

1.9%

ONCOLOGY
















US


1,525


1,267

20.3%

20.3%

-



4,364


3,623

20.4%

20.4%

-

Intl


2,140


1,862

14.9%

13.8%

1.1%



6,406


5,310

20.6%

15.3%

5.3%

WW


3,665


3,129

17.1%

16.5%

0.6%



10,770


8,933

20.6%

17.4%

3.2%

DARZALEX
















US


841


585

43.7%

43.7%

-



2,302


1,540

49.5%

49.5%

-

Intl


739


514

43.7%

42.0%

1.7%



2,076


1,397

48.6%

42.2%

6.4%

WW


1,580


1,099

43.7%

42.9%

0.8%



4,378


2,937

49.1%

46.0%

3.1%

ERLEADA
















US


214


152

40.5%

40.5%

-



578


407

41.8%

41.8%

-

Intl


130


55

*

*

*



329


112

*

*

*

WW


344


206

66.7%

65.8%

0.9%



907


519

74.7%

72.2%

2.5%

IMBRUVICA
















US


413


450

-8.3%

-8.3%

-



1,311


1,329

-1.3%

-1.3%

-

Intl


654


581

12.6%

10.9%

1.7%



1,996


1,682

18.7%

13.1%

5.6%

WW


1,066


1,031

3.5%

2.5%

1.0%



3,307


3,011

9.9%

6.7%

3.2%

ZYTIGA / abiraterone acetate
















US


25


58

-57.0%

-57.0%

-



96


284

-66.2%

-66.2%

-

Intl


523


532

-1.8%

-2.1%

0.3%



1,653


1,564

5.7%

0.9%

4.8%

WW


548


590

-7.2%

-7.5%

0.3%



1,749


1,848

-5.4%

-9.4%

4.0%

OTHER ONCOLOGY
















US


32


21

49.6%

49.6%

-



76


63

21.0%

21.0%

-

Intl


94


181

-48.0%

-47.2%

-0.8%



352


556

-36.6%

-38.5%

1.9%

WW


126


203

-37.6%

-36.9%

-0.7%



428


619

-30.7%

-32.4%

1.7%


REPORTED SALES vs. PRIOR PERIOD ($MM)


REPORTED SALES vs. PRIOR PERIOD ($MM)


THIRD QUARTER


NINE MONTHS






% Change






% Change



2021


2020

Reported

Operational (1)

Currency



2021


2020

Reported

Operational (1)

Currency

PULMONARY HYPERTENSION
















US


610


510

19.7%

19.7%

-



1,778


1,541

15.4%

15.4%

-

Intl


258


239

7.9%

8.4%

-0.5%



821


742

10.7%

7.3%

3.4%

WW


868


749

15.9%

16.1%

-0.2%



2,599


2,283

13.9%

12.7%

1.2%

OPSUMIT
















US


299


244

22.8%

22.8%

-



861


729

18.2%

18.2%

-

Intl


159


148

7.4%

7.8%

-0.4%



510


458

11.3%

7.7%

3.6%

WW


458


392

17.0%

17.1%

-0.1%



1,371


1,187

15.5%

14.1%

1.4%

UPTRAVI
















US


265


226

17.3%

17.3%

-



792


692

14.6%

14.6%

-

Intl


44


34

30.4%

28.8%

1.6%



135


100

34.6%

27.9%

6.7%

WW


309


260

19.0%

18.8%

0.2%



927


792

17.1%

16.2%

0.9%

OTHER PULMONARY HYPERTENSION
















US


47


40

14.4%

14.4%

-



125


121

2.8%

2.8%

-

Intl


54


57

-4.4%

-2.1%

-2.3%



176


183

-3.7%

-5.0%

1.3%

WW


101


97

3.4%

4.8%

-1.4%



301


304

-1.1%

-1.9%

0.8%

CARDIOVASCULAR / METABOLISM / OTHER
















US


800


931

-14.0%

-14.0%

-



2,379


2,574

-7.6%

-7.6%

-

Intl


333


351

-5.1%

-8.2%

3.1%



1,007


1,052

-4.2%

-9.3%

5.1%

WW


1,133


1,281

-11.5%

-12.4%

0.9%



3,386


3,625

-6.6%

-8.1%

1.5%

XARELTO
















US


636


630

0.8%

0.8%

-



1,794


1,716

4.5%

4.5%

-

Intl


-


-

-

-

-



-


-

-

-

-

WW


636


630

0.8%

0.8%

-



1,794


1,716

4.5%

4.5%

-

INVOKANA / INVOKAMET
















US


66


156

-57.4%

-57.4%

-



249


405

-38.4%

-38.4%

-

Intl


67


68

-1.0%

-4.3%

3.3%



194


173

11.9%

5.8%

6.1%

WW


133


224

-40.3%

-41.3%

1.0%



443


578

-23.4%

-25.2%

1.8%

PROCRIT / EPREX
















US


47


69

-30.9%

-30.9%

-



168


215

-21.7%

-21.7%

-

Intl


65


63

3.1%

0.5%

2.6%



198


208

-4.7%

-9.7%

5.0%

WW


112


132

-14.6%

-15.8%

1.2%



366


423

-13.4%

-15.8%

2.4%

OTHER
















US


51


75

-32.6%

-32.6%

-



168


238

-29.3%

-29.3%

-

Intl


200


219

-8.7%

-11.9%

3.2%



615


670

-8.3%

-13.1%

4.8%

WW


251


294

-14.8%

-17.2%

2.4%



783


908

-13.8%

-17.3%

3.5%

TOTAL PHARMACEUTICAL
















US


7,221


6,438

12.2%

12.2%

-



20,536


18,619

10.3%

10.3%

-

Intl


5,773


4,980

15.9%

14.6%

1.3%



17,256


14,685

17.5%

12.5%

5.0%

WW


$        12,994


11,418

13.8%

13.2%

0.6%



$        37,792


33,304

13.5%

11.3%

2.2%


















REPORTED SALES vs. PRIOR PERIOD ($MM)


REPORTED SALES vs. PRIOR PERIOD ($MM)


THIRD QUARTER


NINE MONTHS






% Change






% Change

MEDICAL DEVICES SEGMENT (2)


2021


2020

Reported

Operational (1)

Currency



2021


2020

Reported

Operational (1)

Currency

















INTERVENTIONAL SOLUTIONS
















US


$             444


399

11.1%

11.1%

-



1,353


1,019

32.7%

32.7%

-

Intl


513


437

17.7%

15.1%

2.6%



1,599


1,134

41.1%

34.3%

6.8%

WW


957


836

14.5%

13.2%

1.3%



2,952


2,153

37.1%

33.6%

3.5%

ORTHOPAEDICS
















US


1,249


1,308

-4.5%

-4.5%

-



3,821


3,427

11.5%

11.5%

-

Intl


843


774

8.8%

6.8%

2.0%



2,611


2,145

21.7%

15.4%

6.3%

WW


2,093


2,083

0.5%

-0.3%

0.8%



6,433


5,572

15.4%

13.0%

2.4%

HIPS
















US


210


221

-5.3%

-5.3%

-



654


564

15.9%

15.9%

-

Intl


146


124

18.8%

16.0%

2.8%



451


344

31.3%

24.1%

7.2%

WW


356


345

3.3%

2.3%

1.0%



1,105


908

21.8%

19.0%

2.8%

KNEES
















US


184


205

-9.8%

-9.8%

-



579


527

10.0%

10.0%

-

Intl


131


102

28.1%

25.9%

2.2%



403


298

35.4%

28.2%

7.2%

WW


316


308

2.8%

2.1%

0.7%



983


825

19.2%

16.6%

2.6%

TRAUMA
















US


455


433

5.3%

5.3%

-



1,352


1,194

13.3%

13.3%

-

Intl


260


253

2.4%

0.9%

1.5%



805


698

15.2%

9.5%

5.7%

WW


715


685

4.2%

3.7%

0.5%



2,157


1,892

14.0%

11.9%

2.1%

SPINE, SPORTS & OTHER
















US


400


449

-11.1%

-11.1%

-



1,236


1,142

8.2%

8.2%

-

Intl


306


295

3.5%

1.5%

2.0%



952


805

18.2%

12.0%

6.2%

WW


705


745

-5.3%

-6.1%

0.8%



2,187


1,947

12.3%

9.7%

2.6%


REPORTED SALES vs. PRIOR PERIOD ($MM)


REPORTED SALES vs. PRIOR PERIOD ($MM)


THIRD QUARTER


NINE MONTHS






% Change






% Change



2021


2020

Reported

Operational (1)

Currency



2021


2020

Reported

Operational (1)

Currency

SURGERY
















US


948


913

3.9%

3.9%

-



2,881


2,247

28.2%

28.2%

-

Intl


1,457


1,239

17.6%

14.8%

2.8%



4,418


3,556

24.2%

18.4%

5.8%

WW


2,405


2,152

11.8%

10.2%

1.6%



7,299


5,803

25.8%

22.2%

3.6%

ADVANCED
















US


440


421

4.6%

4.6%

-



1,304


1,079

20.9%

20.9%

-

Intl


705


579

21.8%

18.4%

3.4%



2,126


1,644

29.3%

23.1%

6.2%

WW


1,144


1,000

14.6%

12.6%

2.0%



3,430


2,723

26.0%

22.2%

3.8%

GENERAL
















US


508


492

3.3%

3.3%

-



1,577


1,168

35.0%

35.0%

-

Intl


752


660

13.9%

11.7%

2.2%



2,292


1,912

19.9%

14.5%

5.4%

WW


1,261


1,152

9.4%

8.1%

1.3%



3,869


3,080

25.6%

22.3%

3.3%

VISION
















US


475


473

0.6%

0.6%

-



1,414


1,160

21.9%

21.9%

-

Intl


714


608

17.4%

17.4%

0.0%



2,103


1,683

25.0%

22.0%

3.0%

WW


1,189


1,081

10.1%

10.0%

0.1%



3,517


2,843

23.7%

22.0%

1.7%

CONTACT LENSES / OTHER
















US


359


375

-4.3%

-4.3%

-



1,082


924

17.0%

17.0%

-

Intl


522


455

14.9%

15.2%

-0.3%



1,525


1,274

19.8%

17.3%

2.5%

WW


882


830

6.2%

6.4%

-0.2%



2,607


2,198

18.6%

17.2%

1.4%

SURGICAL
















US


117


98

19.6%

19.6%

-



333


236

41.1%

41.1%

-

Intl


191


153

24.7%

23.7%

1.0%



577


409

41.1%

36.7%

4.4%

WW


308


251

22.7%

22.1%

0.6%



910


645

41.1%

38.3%

2.8%

















TOTAL MEDICAL DEVICES
















US


3,117


3,092

0.8%

0.8%

-



9,470


7,852

20.6%

20.6%

-

Intl


3,527


3,058

15.4%

13.3%

2.1%



10,731


8,518

26.0%

20.5%

5.5%

WW


$          6,644


6,150

8.0%

7.0%

1.0%



$        20,201


16,370

23.4%

20.5%

2.9%

































Note: Columns and rows within tables may not add due to rounding. Percentages have been calculated using actual, non-rounded figures and,
therefore, may not recalculate precisely.


















* Percentage greater than 100% or not meaningful

(1) Operational growth excludes the effect of translational currency






(2) Unaudited












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











(4) Reported as U.S. sales










(PRNewsfoto/Johnson & Johnson)

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SOURCE 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

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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

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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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