Johnson & Johnson Reports 2021 First-Quarter Results:

Johnson & Johnson (NYSE: JNJ) today announced results for first-quarter 2021. "Johnson & Johnson delivered a strong first quarter performance led by the above market growth of our Pharmaceutical business and continued recovery in Medical Devices," said Alex Gorsky Chairman and Chief Executive Officer. "The ability to deliver these results while simultaneously advancing our robust pipeline of life-enhancing medicines, products and solutions during these times is a testament to the strength and resilience of our business and the dedication of the 135,000 employees of Johnson & Johnson who strive every day to profoundly change the trajectory of health for humanity and make healthier communities for everyone, everywhere."

OVERALL FINANCIAL RESULTS:


FIRST QUARTER


($ in Millions, except EPS)

2021

2020

%  Change

Reported Sales

$        22,321

$        20,691

7.9%

Net Earnings

6,197

5,796

6.9

EPS (diluted)

$            2.32

$            2.17

6.9%





Non-GAAP*

FIRST QUARTER


($ in Millions, except EPS)

2021

2020

%  Change

Operational Sales 1,2



5.5%

Adjusted Operational Sales 1,3



6.0

Adjusted Net Earnings 1,4

6,924

6,154

12.5

Adjusted EPS (diluted) 1,4

$            2.59

$            2.30

12.6%



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

4

Excludes intangible amortization expense and special items

REGIONAL SALES RESULTS:


FIRST QUARTER

%  Change

($ in Millions)

2021

2020


Reported


Operational
  1,2


Currency

Adjusted
Operational 1,3

U.S.

$        11,111

$        10,699

3.9%

3.9

-

3.9

International

11,210

9,992

12.2

7.3

4.9

8.2

Worldwide

$        22,321

$        20,691

7.9%

5.5

2.4

6.0



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:


FIRST QUARTER

%  Change

($ in Millions)

2021

2020


Reported


Operational
  1,2


Currency

Adjusted
Operational 1,3

Consumer Health

$          3,543

$          3,625

(2.3)%

(3.3)

1.0

(2.9)

Pharmaceutical

12,199

11,134

9.6

7.1

2.5

7.4

Medical Devices

6,579

5,932

10.9

8.0

2.9

8.8

Worldwide

$        22,321

$        20,691

7.9%

5.5

2.4

6.0



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

FIRST-QUARTER 2021 SEGMENT COMMENTARY:

Consumer Health
Consumer Health worldwide operational sales, excluding the net impact of acquisitions and divestitures, declined 2.9%* primarily driven by negative prior year comparisons related to the COVID-19 pantry loading in Q1 2020, mainly in over-the counter products.  Partially offsetting the decline is growth in LISTERINE in oral care products, JOHNSON'S BABY in baby care products, international skin health/beauty products and NICORETTE in international over-the-counter products.

Pharmaceutical
Pharmaceutical worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 7.4%* 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, ERLEADA (apalutamide), a next-generation androgen receptor inhibitor for the treatment of patients with prostate cancer, TREMFYA (guselkumab), a biologic for the treatment of adults living with moderate to severe plaque psoriasis, and for adults with active psoriatic arthritis, INVEGA SUSTENNA/XEPLION/INVEGA TRINZA/TREVICTA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults, IMBRUVICA (ibrutinib), an oral, once-daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer. This growth was partially offset by 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 U.S. ZYTIGA (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic castration-resistant prostate cancer.

Medical Devices
Medical Devices worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 8.8%*, and reflects the benefit of market recovery from COVID-19 impacts in the prior year. Contributors to growth were electrophysiology products in the Interventional Solutions business, worldwide biosurgery and energy products, and international endocutters in Advanced Surgery, wound closure products in General Surgery, contact lenses and surgery in the Vision business and trauma products in Orthopaedics; partially offset by knee products in Orthopaedics.

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
Decisions

PONVORY (ponesimod) approved by U.S. FDA, an oral treatment for adults with relapsing
multiple sclerosis proven superior to (teriflunomide) in reducing annual relapses and brain
lesions

(press release)

Johnson & Johnson Single-Shot COVID-19 Vaccine granted conditional marketing
authorization by European Commission

(press release)

Johnson & Johnson Single-Shot COVID-19 Vaccine granted emergency use listing by the
World Health Organization

(press release)

Johnson & Johnson COVID-19 Vaccine authorized by U.S. FDA for emergency use

(press release)

SPRAVATO (Esketamine Nasal Spray) authorized in Europe for the rapid reduction of
depressive symptoms in a psychiatric emergency for patients with major depressive disorder

(press release)

MONOFOCAL INTRAOCULAR LENS - TECNIS EYHANCE AND TECNIS EYHANCE
TORIC II IOLS - receives FDA approval for a next generation treatment for cataract patients

(press release)

Regulatory
Submission

Submission of supplemental new drug application to U.S. FDA by ViiV Healthcare for
expanded use of CABENUVA (rilpivirine and cabotegravir) as an HIV treatment for use
every two months

(press release)

Other

Janssen provides update on Phase 3 ACIS Study in patients with metastatic castration-
resistant prostate cancer treated with ERLEADA (apalutamide) and ZYTIGA (abiraterone
acetate) plus prednisone combination ¹

(press release)

Johnson & Johnson announces advance purchase agreement with the African Vaccine
Acquisition Trust for the Company's COVID-19 vaccine candidate

(press release)

PONVORY (ponesimod) receives positive CHMP opinion for the treatment of adults with
relapsing forms of multiple sclerosis with active disease defined by clinical or imaging features

(press release)

CAR-T Therapy Ciltacabtagene Autoleucel (Cilta-cel) accepted for accelerated assessment
in Europe for the treatment of patients with heavily pretreated multiple myeloma

(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)

January 2021

April 2021

Adjusted Operational Sales 1,2

Change vs. Prior Year

8.0% - 9.5%

8.7% - 9.9%

Operational Sales 2

Change vs. Prior Year

$88.8B - $90.0B

7.5% – 9.0%

$89.3B - $90.3B

8.2% – 9.4%

Estimated Reported Sales 3

Change vs. Prior Year

$90.5B - $91.7B

9.5% – 11.0%

$90.6B - $91.6B

9.7% – 10.9%




Adjusted Operational EPS (Diluted) 2,4

Change vs. Prior Year

$9.25 - $9.45

15.2% - 17.7%

$9.30 - $9.45

15.8% - 17.7%

Adjusted EPS (Diluted) 3,4

Change vs. Prior Year

$9.40 - $9.60

17.1% - 19.6%

$9.42 - $9.57

17.3% - 19.2%



1

Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures

2

Non-GAAP financial measure; excludes the impact of translational currency

3

Calculated using Euro Average Rate: January 2021 = $1.21 and April 2021 = $1.19 (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 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)


FIRST QUARTER







Percent Change



2021


2020


Total


Operations


Currency

Sales to customers by











segment of business






















Consumer Health











U.S.


$     1,611


1,740


(7.4)

%

(7.4)


-

International


1,932


1,885


2.5


0.5


2.0



3,543


3,625


(2.3)


(3.3)


1.0












Pharmaceutical











U.S.


6,446


6,061


6.4


6.4


-

International


5,753


5,073


13.4


7.9


5.5



12,199


11,134


9.6


7.1


2.5












Medical Devices











U.S.


3,054


2,898


5.4


5.4


-

International


3,525


3,034


16.2


10.5


5.7



6,579


5,932


10.9


8.0


2.9












U.S.


11,111


10,699


3.9


3.9


-

International


11,210


9,992


12.2


7.3


4.9

Worldwide


$   22,321


20,691


7.9

%

5.5


2.4












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)

FIRST QUARTER






Percent Change


2021


2020


Total


Operations


Currency

Sales to customers by










geographic area




















U.S.

$    11,111


10,699


3.9

%

3.9


-











Europe

5,414


4,827


12.1


4.7


7.4

Western Hemisphere excluding U.S.

1,424


1,502


(5.1)


0.0


(5.1)

Asia-Pacific, Africa

4,372


3,663


19.4


13.7


5.7

International

11,210


9,992


12.2


7.3


4.9











Worldwide

$    22,321


20,691


7.9

%

5.5


2.4











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)

FIRST QUARTER












2021


2020


Percent




Percent




Percent


Increase


Amount


to Sales


Amount


to Sales


(Decrease)

Sales to customers

$      22,321


100.0


$      20,691


100.0


7.9

Cost of products sold

7,063


31.7


7,062


34.1


0.0

Gross Profit

15,258


68.3


13,629


65.9


12.0

Selling, marketing and administrative expenses

5,432


24.3


5,203


25.1


4.4

Research and development expense

3,178


14.2


2,580


12.5


23.2

Interest (income) expense, net

48


0.2


(42)


(0.2)



Other (income) expense, net

(882)


(3.9)


(679)


(3.3)



Restructuring

53


0.2


58


0.3



Earnings before provision for taxes on income

7,429


33.3


6,509


31.5


14.1

Provision for taxes on income

1,232


5.5


713


3.5


72.8

Net earnings

6,197


27.8


5,796


28.0


6.9











Net earnings per share (Diluted)

$          2.32




$          2.17




6.9











Average shares outstanding (Diluted)

2,672.7




2,671.0















Effective tax rate

16.6

%



11.0

%














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










Earnings before provision for taxes on income

$        8,291


37.1


$        7,244


35.0


14.5

Net earnings

$        6,924


31.0


$        6,154


29.7


12.5

Net earnings per share (Diluted)

$          2.59




$          2.30




12.6

Effective tax rate

16.5

%



15.0

%














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










Johnson & Johnson and Subsidiaries





Reconciliation of Non-GAAP Financial Measures








First Quarter


(Dollars in Millions Except Per Share Data)


2021


2020


Net Earnings, after tax- as reported


$6,197


$5,796








Pre-tax Adjustments






Intangible Asset Amortization expense


1,215


1,118


Litigation expense


-


120


Restructuring related


104


118


Acquisition, integration and divestiture related 1


(538)


(962)


Unrealized (gains)/losses on securities


35


327


Medical Device Regulation


46


14








Tax Adjustments






Tax impact on special item adjustments 2


(113)


(267)


Tax legislation and other tax related


(22)


(110)


Adjusted Net Earnings, after tax


$6,924


$6,154


Average shares outstanding (Diluted)


2,672.7


2,671.0


Adjusted net earnings per share (Diluted)


$2.59


$2.30


Operational adjusted net earnings per share (Diluted)


$2.49










Notes:





1

Acquisition, integration and divestiture related for the first quarter of 2021 primarily includes the gain on the divestiture of 2
Pharmaeutical brands outside of the U.S.  The first quarter of 2020 primarily includes a $983M Contingent Consideration reversal
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

FIRST QUARTER 2021 ACTUAL vs. 2020 ACTUAL


Segments



Consumer Health


Pharmaceutical


Medical Devices


Total

WW As Reported


(2.3)%


9.6%


10.9%


7.9%

U.S.


(7.4)%


6.4%


5.4%


3.9%

International


2.5%


13.4%


16.2%


12.2%










WW Currency


1.0


2.5


2.9


2.4

U.S.


-


-


-


-

International


2.0


5.5


5.7


4.9










WW Operational


(3.3)%


7.1%


8.0%


5.5%

U.S.


(7.4)%


6.4%


5.4%


3.9%

International


0.5%


7.9%


10.5%


7.3%










General Surgery









Advanced Sterilization Products






0.6


0.2

U.S.






0.0


0.0

International






1.2


0.4










All Other Acquisitions and Divestitures


0.4


0.3


0.1


0.3

U.S.


0.5


(0.2)


0.2


0.0

International


0.4


0.9


0.0


0.5










WW Adjusted Operational


(2.9)%


7.4%


8.8%


6.0%

U.S.


(6.9)%


6.2%


5.6%


3.9%

International


0.9%


8.8%


11.8%


8.2%










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






REPORTED SALES vs. PRIOR PERIOD ($MM)



FIRST QUARTER








% Change





2021


2020

Reported

Operational (1)

Currency



CONSUMER HEALTH SEGMENT (2)










OTC










US


$              599


689

-13.0%

-13.0%

-



Intl


575


659

-12.8%

-16.6%

3.8%



WW


1,175


1,348

-12.9%

-14.8%

1.9%



SKIN HEALTH / BEAUTY










US


634


659

-3.9%

-3.9%

-



Intl


529


458

15.7%

12.3%

3.4%



WW


1,163


1,117

4.1%

2.8%

1.3%



ORAL CARE










US


163


176

-7.2%

-7.2%

-



Intl


254


219

16.0%

13.9%

2.1%



WW


417


395

5.7%

4.5%

1.2%



BABY CARE










US


96


92

4.2%

4.2%

-



Intl


293


269

8.9%

11.3%

-2.4%



WW


389


361

7.7%

9.5%

-1.8%



WOMEN'S HEALTH










US


3


4

-25.8%

-25.8%

-



Intl


219


228

-3.9%

-2.2%

-1.7%



WW


222


232

-4.3%

-2.6%

-1.7%



WOUND CARE / OTHER










US


115


119

-3.0%

-3.0%

-



Intl


61


52

17.6%

14.2%

3.4%



WW


177


171

3.3%

2.2%

1.1%













TOTAL CONSUMER HEALTH










US


1,611


1,740

-7.4%

-7.4%

-



Intl


1,932


1,885

2.5%

0.5%

2.0%



WW


$           3,543


3,625

-2.3%

-3.3%

1.0%























See footnotes at end of schedule










































REPORTED SALES vs. PRIOR PERIOD ($MM)


FIRST QUARTER








% Change



PHARMACEUTICAL SEGMENT (2,3)


2021


2020

Reported

Operational (1)

Currency













IMMUNOLOGY










US


$           2,413


2,410

0.1%

0.1%

-



Intl


1,501


1,228

22.3%

15.9%

6.4%



WW


3,914


3,638

7.6%

5.5%

2.1%



REMICADE










US


489


625

-21.7%

-21.7%

-



US Exports (4)


57


110

-48.4%

-48.4%

-



Intl


232


256

-9.4%

-12.1%

2.7%



WW


777


990

-21.5%

-22.2%

0.7%



SIMPONI / SIMPONI ARIA










US


255


272

-5.9%

-5.9%

-



Intl


307


258

18.9%

13.8%

5.1%



WW


562


529

6.2%

3.7%

2.5%



STELARA










US


1,331


1,217

9.4%

9.4%

-



Intl


817


603

35.6%

27.6%

8.0%



WW


2,148


1,819

18.1%

15.4%

2.7%



TREMFYA










US


274


187

46.3%

46.3%

-



Intl


143


109

32.0%

23.1%

8.9%



WW


418


296

41.0%

37.8%

3.2%



OTHER IMMUNOLOGY










US


7


-

*

*

-



Intl


2


3

-38.4%

-36.3%

-2.1%



WW


8


3

*

*

*



INFECTIOUS DISEASES










US


512


436

17.4%

17.4%

-



Intl


494


483

2.3%

-2.2%

4.5%



WW


1,007


920

9.5%

7.1%

2.4%



COVID-19 VACCINE










US


100


-

*

*

-



Intl


-


-

-

-

-



WW


100


-

*

*

-



EDURANT / rilpivirine










US


10


12

-12.3%

-12.3%

-



Intl


233


212

9.8%

0.9%

8.9%



WW


243


224

8.6%

0.2%

8.4%



PREZISTA / PREZCOBIX / REZOLSTA / SYMTUZA










US


380


396

-3.8%

-3.8%

-



Intl


166


184

-9.9%

-10.4%

0.5%



WW


546


579

-5.8%

-5.9%

0.1%



OTHER INFECTIOUS DISEASES










US


21


29

-27.0%

-27.0%

-



Intl


96


87

9.7%

7.4%

2.3%



WW


117


116

0.6%

-1.2%

1.8%



































REPORTED SALES vs. PRIOR PERIOD ($MM)



FIRST QUARTER








% Change





2021


2020

Reported

Operational (1)

Currency



NEUROSCIENCE










US


771


748

3.2%

3.2%

-



Intl


949


910

4.3%

0.4%

3.9%



WW


1,721


1,658

3.8%

1.6%

2.2%



CONCERTA / Methylphenidate










US


47


52

-9.6%

-9.6%

-



Intl


123


118

4.5%

-0.4%

4.9%



WW


171


171

0.2%

-3.2%

3.4%



INVEGA SUSTENNA / XEPLION /
INVEGA TRINZA / TREVICTA










US


589


544

8.3%

8.3%

-



Intl


376


339

11.0%

4.5%

6.5%



WW


965


883

9.4%

6.9%

2.5%



RISPERDAL CONSTA










US


67


76

-11.8%

-11.8%

-



Intl


89


94

-4.8%

-8.8%

4.0%



WW


157


170

-7.9%

-10.1%

2.2%



OTHER NEUROSCIENCE










US


67


75

-9.8%

-9.8%

-



Intl


361


360

0.2%

-0.9%

1.1%



WW


428


435

-1.5%

-2.5%

1.0%



ONCOLOGY










US


1,377


1,175

17.2%

17.2%

-



Intl


2,193


1,839

19.3%

12.9%

6.4%



WW


3,570


3,013

18.5%

14.6%

3.9%



DARZALEX










US


691


463

49.2%

49.2%

-



Intl


674


474

42.2%

35.3%

6.9%



WW


1,365


937

45.6%

42.2%

3.4%



ERLEADA










US


171


119

44.0%

44.0%

-



Intl


90


24

*

*

*



WW


261


143

82.8%

79.7%

3.1%



IMBRUVICA










US


444


432

2.8%

2.8%

-



Intl


680


599

13.5%

7.6%

5.9%



WW


1,125


1,031

9.0%

5.6%

3.4%



ZYTIGA / abiraterone acetate










US


50


139

-64.2%

-64.2%

-



Intl


588


552

6.6%

0.0%

6.6%



WW


638


690

-7.6%

-12.9%

5.3%



OTHER ONCOLOGY (5)










US


21


22

-5.1%

-5.1%

-



Intl


161


190

-15.3%

-19.3%

4.0%



WW


182


212

-14.2%

-17.9%

3.7%



































REPORTED SALES vs. PRIOR PERIOD ($MM)




FIRST QUARTER








% Change





2021


2020

Reported

Operational (1)

Currency



PULMONARY HYPERTENSION










US


573


486

18.0%

18.0%

-



Intl


288


260

10.8%

5.6%

5.2%



WW


861


745

15.5%

13.7%

1.8%



OPSUMIT










US


272


229

18.5%

18.5%

-



Intl


179


160

11.5%

6.3%

5.2%



WW


450


389

15.6%

13.5%

2.1%



UPTRAVI










US


259


212

21.9%

21.9%

-



Intl


46


38

23.0%

15.7%

7.3%



WW


305


250

22.0%

20.9%

1.1%



OTHER PULMONARY HYPERTENSION










US


42


44

-3.5%

-3.5%

-



Intl


63


62

1.4%

-2.1%

3.5%



WW


105


106

-0.6%

-2.7%

2.1%



CARDIOVASCULAR / METABOLISM / OTHER










US


799


806

-0.9%

-0.9%

-



Intl


328


354

-7.2%

-11.3%

4.1%



WW


1,127


1,160

-2.8%

-4.1%

1.3%



XARELTO










US


589


527

11.7%

11.7%

-



Intl


-


-

-

-

-



WW


589


527

11.7%

11.7%

-



INVOKANA / INVOKAMET










US


87


117

-26.1%

-26.1%

-



Intl


63


58

9.2%

4.2%

5.0%



WW


150


175

-14.4%

-16.1%

1.7%



PROCRIT / EPREX










US


62


76

-18.3%

-18.3%

-



Intl


64


79

-18.1%

-22.2%

4.1%



WW


127


155

-18.2%

-20.3%

2.1%



OTHER










US


60


85

-28.8%

-28.8%

-



Intl


201


217

-7.7%

-11.5%

3.8%



WW


261


302

-13.6%

-16.4%

2.8%



TOTAL PHARMACEUTICAL










US


6,446


6,061

6.4%

6.4%

-



Intl


5,753


5,073

13.4%

7.9%

5.5%



WW


$         12,199


11,134

9.6%

7.1%

2.5%













See footnotes at end of schedule




















































REPORTED SALES vs. PRIOR PERIOD ($MM)




FIRST QUARTER








% Change



MEDICAL DEVICES SEGMENT (2)


2021


2020

Reported

Operational (1)

Currency













INTERVENTIONAL SOLUTIONS










US


$              434


365

19.0%

19.0%

-



Intl


514


362

42.0%

34.0%

8.0%



WW


949


727

30.4%

26.4%

4.0%



ORTHOPAEDICS










US


1,249


1,250

-0.1%

-0.1%

-



Intl


864


788

9.7%

3.1%

6.6%



WW


2,113


2,038

3.7%

1.2%

2.5%



HIPS










US


210


206

2.4%

2.4%

-



Intl


146


132

11.2%

4.5%

6.7%



WW


357


337

5.8%

3.2%

2.6%



KNEES










US


185


214

-13.5%

-13.5%

-



Intl


132


130

2.0%

-4.1%

6.1%



WW


317


343

-7.6%

-9.9%

2.3%



TRAUMA










US


450


407

10.7%

10.7%

-



Intl


282


247

14.4%

7.7%

6.7%



WW


733


654

12.1%

9.5%

2.6%



SPINE, SPORTS & OTHER










US


403


423

-4.8%

-4.8%

-



Intl


303


280

8.4%

1.7%

6.7%



WW


706


703

0.4%

-2.2%

2.6%













































REPORTED SALES vs. PRIOR PERIOD ($MM)




FIRST QUARTER








% Change





2021


2020

Reported

Operational (1)

Currency



SURGERY










US


898


844

6.5%

6.5%

-



Intl


1,474


1,257

17.3%

11.7%

5.6%



WW


2,372


2,100

12.9%

9.6%

3.3%



ADVANCED










US


405


381

6.5%

6.5%

-



Intl


713


567

25.7%

19.5%

6.2%



WW


1,118


948

18.0%

14.3%

3.7%



GENERAL










US


493


463

6.5%

6.5%

-



Intl


761


690

10.3%

5.3%

5.0%



WW


1,254


1,153

8.8%

5.8%

3.0%



VISION










US


472


439

7.4%

7.4%

-



Intl


673


628

7.3%

3.9%

3.4%



WW


1,145


1,067

7.3%

5.4%

1.9%



CONTACT LENSES / OTHER










US


371


346

7.2%

7.2%

-



Intl


486


467

4.0%

0.9%

3.1%



WW


857


814

5.3%

3.5%

1.8%



SURGICAL










US


101


93

8.2%

8.2%

-



Intl


187


160

17.0%

12.9%

4.1%



WW


288


253

13.7%

11.2%

2.5%













TOTAL MEDICAL DEVICES










US


3,054


2,898

5.4%

5.4%

-



Intl


3,525


3,034

16.2%

10.5%

5.7%



WW


$           6,579


5,932

10.9%

8.0%

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










(5) Refer to supplemental schedule





























Supplemental Sales Information

(Dollars in Millions)

Prior quarter amounts have been reclassified to

conform to current quarter product disclosure



2019


2020


2020





















PHARMACEUTICAL SEGMENT (1)


Full Year




Q1


Q2


Q3


Q4



Full Year




Oncology



















OTHER ONCOLOGY (2)



















US


70




22


20


21


20



83




Intl


1,087




190


185


181


183



738




WW


1,158




212


204


203


202



821





























































Note : Columns and rows within tables may not add due to rounding.
































(1) Unaudited



















(2) Other Oncology is inclusive of VELCADE, which was previously disclosed separately










(PRNewsfoto/Johnson & Johnson)

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/johnson--johnson-reports-2021-first-quarter-results-301272130.html

SOURCE Johnson & Johnson

News Provided by PR Newswire via QuoteMedia

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-360â„¢ single-shot PFA catheter show impressive safety, performance, and efficiency results for paroxysmal Afib
  • Dual-energy (RF/PF), focal Sphere-9â„¢ 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 Afferaâ„¢ family of technologies, including the next-generation Sphere-360â„¢ single-shot pulsed field ablation (PFA) catheter and the groundbreaking Sphere-9â„¢ 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 PulseSelectâ„¢ 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 Hugoâ„¢ 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 MiniMedâ„¢ 780G pump as an alternate controller enabled (ACE) insulin pump and a separate 510(k) application for its SmartGuardâ„¢ 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

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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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