Financial

Medtronic reports full year and fourth quarter fiscal 2024 financial results; announces dividend increase

Broad-based, durable growth across the company, including Cranial & Spinal Technologies, Diabetes, Cardiac Pacing, Surgical, and Structural Heart; gaining momentum as company enters new product cycles across many high-growth marketsDUBLIN, May 23, 2024 /PRNewswire/ — Medtronic plc (NYSE:MDT) today announced financial results for its fourth quarter (Q4) and fiscal year 2024 (FY24), which ended April 26, 2024.Key Highlights

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Q4 revenue of $8.6 billion increased 0.5% as reported and 5.4% organic
Q4 GAAP diluted earnings per share (EPS) of $0.49; non-GAAP diluted EPS of $1.46
FY24 revenue of $32.4 billion increased 3.6% as reported and 5.2% organic
FY24 GAAP diluted EPS of $2.76; non-GAAP diluted EPS of $5.20
FY24 cash from operations of $6.8 billion increased 12%; FY24 free cash flow of $5.2 billion increased 14%
Company returned $5.5 billion to shareholders in FY24, including $1.6 billion through net share repurchases in Q4
Company issues FY25 guidance
Dividend increased to $0.70 per share quarterly, annual $2.80 per share; 47th consecutive year of dividend increases
Received U.S. FDA approval for Evolut™ FX+ TAVR system and Inceptiv™ closed-loop spinal cord stimulator; received China National Medical Products Administration (NMPA) approval for Symplicity Spyral™ renal denervation system; submitted Affera Sphere-9™ ablation catheter and Simplera Sync™ CGM to U.S. FDA seeking approval

Q4 Financial ResultsMedtronic reported Q4 worldwide revenue of $8.589 billion, an increase of 0.5% as reported and 5.4% on an organic basis. The company’s organic revenue results reflect broad-based growth across the company, with mid-single digit or higher organic revenue growth in all four segments. The organic revenue growth comparison excludes:
$57 million of current year revenue and $114 million of prior year revenue reported as Other, stemming from business separations and product line exits;
$72 million of unfavorable impact from foreign currency translation on the remaining segments; and
$265 million of prior year revenue from a one-time intellectual property (IP) agreement, which was reported in the Structural Heart & Aortic division in the Cardiovascular Portfolio
As reported, Q4 GAAP net income and diluted EPS were $654 million and $0.49, respectively, decreases of 45% and 44%, respectively. As detailed in the financial schedules included at the end of this release, Q4 non-GAAP net income and non-GAAP diluted EPS were $1.929 billion and $1.46, respectively, decreases of 8% and 7%, respectively. Included in Q4 non-GAAP diluted EPS was a 7 cent, or 4%, unfavorable impact from foreign currency translation.FY24 Financial ResultsMedtronic reported FY24 worldwide revenue of $32.364 billion, an increase of 3.6% as reported and 5.2% on an organic basis. The FY24 organic revenue growth comparison excludes:
$111 million of current year revenue and $358 million of prior year revenue reported as Other, stemming from business separations and product line exits;
$43 million of favorable impact from foreign currency translation on the remaining segments; and
$265 million of prior year revenue from a one-time IP agreement.
FY24 GAAP net income and diluted earnings per share (EPS) were $3.676 billion and $2.76, respectively, both representing decreases of 2%. As detailed in the financial schedules included at the end of this release, fiscal year 2024 non-GAAP net income and non-GAAP diluted EPS were $6.918 billion and $5.20, respectively, both representing decreases of 2%. Included in FY24 non-GAAP diluted EPS was a 33 cent unfavorable impact from foreign currency translation. FY24 non-GAAP diluted EPS on a constant currency basis increased 5%.FY24 cash from operations of $6.787 billion increased 12%. FY24 free cash flow of $5.200 billion increased 14%, representing free cash flow conversion from non-GAAP net earnings of 75%. Growth was driven by improvements in working capital.”We delivered a strong finish to the fiscal year, with broad strength across our businesses and each of our four segments posting mid-single digit or higher organic revenue growth,” said Geoff Martha, Medtronic chairman and chief executive officer. “Our momentum is building into the new fiscal year. We’re beginning new product cycles in some of MedTech’s most attractive markets, which is further enhanced as we apply AI across our portfolio. We are very optimistic about what we can achieve in fiscal ’25 and beyond.”Cardiovascular PortfolioThe Cardiovascular Portfolio includes the Cardiac Rhythm & Heart Failure (CRHF), Structural Heart & Aortic (SHA), and Coronary & Peripheral Vascular (CPV) divisions. FY24 revenue of $11.831 billion increased 2.7% as reported and 5.0% organic, with a high-single digit increase in SHA, mid-single digit increase in CPV, and a low-single digit increase in CRHF, all on an organic basis. Q4 revenue of $3.130 billion decreased 5.2% as reported and increased 4.0% organic, with mid-single digit organic increases in SHA and CPV, and a low-single digit organic increase in CRHF.
CRHF Q4 results included low-single digit growth in Cardiac Rhythm Management, driven by high-single digit growth in Cardiac Pacing Therapies, including low-20s growth in Micra™ transcatheter pacing systems; Cardiac Ablation Solutions grew mid-single digits, with declines in cryoablation more than offset by strong growth in pulsed field ablation (PFA)
SHA Q4 results driven by high-single digit growth in Structural Heart and Cardiac Surgery; Structural Heart had double digit growth in Western Europe and Japan on the continued adoption of the Evolut™ FX transcatheter aortic valve replacement (TAVR) system
CPV in Q4 delivered mid-single digit Coronary growth with strength in guide catheters and balloons; Peripheral Vascular Health also grew mid-single digits, with mid-teens growth in drug-coated balloons and vascular embolization products
Received U.S. FDA approval for Evolut™ FX+ TAVR system in March, with early commercial experience this spring 2024 and full product launch in summer 2024; Launched Avalus Ultra™ surgical aortic tissue value in the U.S.; Symplicity Spyral™ renal denervation system received National Medical Products Administration (NMPA) approval in China and license from Health Canada
One-year results from SMART trial simultaneously presented at American College of Cardiology and published in The New England Journal of Medicine in April, demonstrating Medtronic Evolut™ TAVR platform as optimal treatment for severe aortic stenosis in patients with small annuli, which is primarily women
First-in-human data studying the Sphere-360™ PFA catheter presented at European Heart Rhythm Association annual meeting in April; one-year results from SPHERE-PER AF pivotal study of the Sphere-9™ pulsed field (PF) and radiofrequency (RF) ablation, and high density (HD) mapping catheter with the Affera cardiac mapping and navigation platform presented at Heart Rhythm last week, system has been submitted to U.S. FDA seeking approval
Neuroscience PortfolioThe Neuroscience Portfolio includes the Cranial & Spinal Technologies (CST), Specialty Therapies, and Neuromodulation divisions. FY24 revenue of $9.406 billion increased 5.0% as reported and 5.2% organic, with a high-single digit increase in CST, mid-single digit increase in Specialty Therapies, and a low-single digit increase in Neuromodulation, all on an organic basis. Q4 revenue of $2.545 billion increased 5.6% as reported and 6.5% organic, with a high-single digit increase in CST, a mid-single digit increase in Neuromodulation, and low-single digit increase in Specialty Therapies, all on an organic basis.
CST Q4 performance driven by continued adoption of the AiBLE™ ecosystem, with mid-teens growth in Neurosurgery on strong capital equipment sales, high-single digit growth in Biologics, and mid-single digit growth in Core Spine
Specialty Therapies Q4 results driven by high-single digit growth in ENT, with strength in power capital and disposables and localized drug delivery sinus implants; Neurovascular declined low-single digits, as declines in China due to volume-based procurement tenders offset strength in flow diversion products; Pelvic Health increased mid-single digits on continued adoption of the InterStim X™ system
Neuromodulation in Q4 delivered low-double digit growth in Brain Modulation on the launch of the Percept™ RC neurostimulator with BrainSense™ technology; Pain Therapies grew mid-single digits, including low-double digit growth in Targeted Drug Delivery and low-single digit growth in Pain Stim
Received U.S. FDA approval for Inceptiv™ closed-loop spinal cord stimulator on last day of Q4; received U.S. FDA clearance for OsteoCool™ 2.0 bone tumor ablation system in Q4, with broad market launch planned later this calendar year
Medical Surgical PortfolioThe Medical Surgical Portfolio includes the Surgical & Endoscopy (SE) and the Acute Care & Monitoring (ACM) divisions. FY24 revenue of $8.417 billion increased 5.4% as reported and 4.7% organic, with a mid-single digit increase in SE and low-single digit increase in ACM, both on an organic basis. Q4 revenue of $2.198 billion increased 3.5% as reported and 4.5% organic, with mid-single digit organic growth in SE and low-single digit organic growth in ACM.
SE Q4 results included high-single digit growth in General Surgical Technologies, with strength in wound management and hernia products, low-single digit growth in Advanced Surgical Technologies, and high-single digit growth in Endoscopy on strength of capital sales
ACM Q4 performance driven by mid-single digit growth in Blood Oxygen Management on strong sales of Nellcor™ pulse oximetry products, and mid-single digit growth in Airways, driven by strong McGRATH™ MAC video laryngoscope demand
Launched Touch Surgery™ Live Stream and 14 new AI-driven algorithms on the Touch Surgery™ Performance Insights platform for laparoscopic and robotic-assisted procedures; received U.S. FDA clearance for the BIS™ Advance anesthesia monitor; started enrollment in two new U.S. indication studies for the Hugo™ robotic-assisted surgery system:  Hernia and Gynecology
DiabetesDiabetes FY24 revenue of $2.488 billion increased 10.0% as reported and 8.6% organic. Q4 revenue of $660 million increased 10.9% as reported and 11.1% organic.
U.S. Q4 revenue grew low-double digits on the continued launch of the MiniMed™ 780G system; high-forties growth in U.S. insulin pump sales with strong growth in sales to new patients
Non-U.S. Developed Markets grew high-single digits on continued MiniMed™ 780G system adoption and increased CGM attachment rates
Submitted Simplera Sync™ CGM to U.S. FDA in Q4 seeking approval for use with the MiniMed™ 780G system
GuidanceThe company today issued its fiscal year 2025 (FY25) revenue growth and EPS guidance.The company is guiding to FY25 organic revenue growth in the range of 4% to 5%. The organic revenue growth guidance excludes the impact of foreign currency exchange and revenue reported as Other. Including Other revenue and the impact of foreign currency exchange, if recent foreign currency exchange rates hold, FY25 revenue growth on a reported basis would be in the range of 2.4% to 3.7%.The company is guiding to FY25 diluted non-GAAP EPS in the range of $5.40 to $5.50, including an estimated 5% unfavorable impact from foreign currency exchange based on recent rates. This would represent FY25 diluted non-GAAP EPS growth in the range of 4 to 6%.Dividend IncreaseThe company today announced that effective May 22, 2024, the Medtronic board of directors approved an increase in Medtronic’s cash dividend for the first quarter of fiscal year 2025, raising the quarterly amount to $0.70 per ordinary share. This would translate into an annual amount of $2.80 per ordinary share. Medtronic has a long history of dividend growth, and the company is a constituent of the S&P 500 Dividend Aristocrats index. Today’s announcement marks the 47th consecutive year of an increase in the dividend payment. Including today’s increase, Medtronic’s dividend per share has grown by 30% over the past 5 years, 130% over the past 10 years, and has grown at a 16% compounded annual growth rate over the past 47 years.Medtronic has a strong track record of returning capital to its shareholders, including $5.5 billion in fiscal year 2024. The company remains committed to returning a minimum of 50% of its free cash flow to shareholders, primarily through dividends, and to a lesser extent, share repurchases. The dividend is payable on July 12, 2024, to shareholders of record at the close of business on June 28, 2024.”We delivered on our commitments in the fourth quarter and the fiscal year, driving durable revenue growth, improved earnings power, and strong free cash flow,” said Karen Parkhill, Medtronic EVP & chief financial officer. “Our fiscal 2025 guidance, along with our dividend increase and recent share repurchase, reflects our confidence in our continued trajectory.”Video Webcast InformationMedtronic will host a video webcast today, May 23, at 8:00 a.m. EDT (7:00 a.m. CDT) to provide information about its businesses for the public, investors, analysts, and news media. This webcast can be accessed by clicking on the Events icon at investorrelations.medtronic.com, and this earnings release will be archived at news.medtronic.com. Within 24 hours of the webcast, a replay of the webcast and transcript of the company’s prepared remarks will be available by clicking on the Events icon at investorrelations.medtronic.com.Medtronic plans to report its FY25 first, second, third, and fourth quarter results on Tuesday, August 20, 2024, November 19, 2024, February 18, 2025, and Thursday, May 22, 2025, respectively. Confirmation and additional details will be provided closer to the specific event.Financial Schedules and Earnings PresentationThe fourth quarter financial schedules and non-GAAP reconciliations can be viewed by clicking on the Investor Events link at investorrelations.medtronic.com. To view a printable PDF of the financial schedules and non-GAAP reconciliations, click here. To view the fourth quarter earnings presentation, click here.

MEDTRONIC PLC WORLD WIDE REVENUE(1) (Unaudited)

FOURTH QUARTER

FISCAL YEAR

REPORTED

ORGANIC

REPORTED

ORGANIC

(in millions)
FY24

FY23

Growth

Currency Impact(3)

Adjusted FY24(4)

Adjusted FY23(5)

AdjustedGrowth

FY24

FY23

Growth

CurrencyImpact(3)

Adjusted FY24(4)

Adjusted FY23(5)

Adjusted Growth

Cardiovascular
$    3,130

$    3,302

(5.2) %

$       (28)

$    3,158

$    3,037

4.0 %

$   11,831

$   11,522

2.7 %

$         12

$   11,819

$   11,257

5.0 %

Cardiac Rhythm & Heart Failure
1,587

1,567

1.3

(15)

1,602

1,567

2.2

5,995

5,783

3.7

11

5,984

5,783

3.5

Structural Heart & Aortic
883

1,105

(20.1)

(6)

889

840

5.8

3,358

3,363

(0.1)

11

3,347

3,098

8.0

Coronary & Peripheral Vascular
660

631

4.6

(7)

667

631

5.7

2,478

2,375

4.3

(10)

2,488

2,375

4.8

Neuroscience
2,545

2,410

5.6

(21)

2,566

2,410

6.5

9,406

8,959

5.0

(16)

9,422

8,959

5.2

Cranial & Spinal Technologies
1,291

1,198

7.8

(11)

1,302

1,198

8.7

4,756

4,451

6.9

(11)

4,767

4,451

7.1

Specialty Therapies
778

763

2.0

(9)

787

763

3.1

2,905

2,815

3.2

(12)

2,917

2,815

3.6

Neuromodulation
475

449

5.8

(1)

476

449

6.0

1,746

1,693

3.1

7

1,739

1,693

2.7

Medical Surgical
2,198

2,124

3.5

(22)

2,220

2,124

4.5

8,417

7,989

5.4

16

8,512

8,127

4.7

Surgical & Endoscopy
1,705

1,638

4.1

(15)

1,720

1,638

5.0

6,508

6,152

5.8

20

6,488

6,152

5.5

Acute Care & Monitoring
492

486

1.2

(6)

498

486

2.5

1,908

1,837

3.9

(4)

2,024

1,975

2.5

Diabetes
660

595

10.9

(1)

661

595

11.1

2,488

2,262

10.0

31

2,457

2,262

8.6

Other (2)
57

114

(50.0)

(3)

221

495

(55.4)

(12)

TOTAL
$    8,589

$    8,544

0.5 %

$       (75)

$    8,604

$    8,165

5.4 %

$   32,364

$   31,227

3.6 %

$         31

$   32,210

$   30,604

5.2 %

(1)
The data in this schedule has been intentionally rounded to the nearest million and, therefore, may not sum.

(2)
Includes historical operations and ongoing transition agreements from businesses the Company has exited or divested, which primarily includes the Company’s ventilator product line and the Renal Care Solutions (RCS) business.

(3)
The currency impact to revenue measures the change in revenue between current and prior year periods using constant exchange rates.

(4)
The three and twelve months ended April 26, 2024 excludes $57 million and $111 million, respectively, of inorganic revenue related to the activity noted in (2) and $72 million of unfavorable currency impact and $43 million of favorable currency impact on the remaining segments, respectively. The fiscal year organic revenue calculation reclassifies the first nine months of ventilator product line revenue of $110 million from the Other line to the Acute Care and Monitoring division of the Medical Surgical Portfolio.

(5)
The three and twelve months ended April 28, 2023 excludes $379 million and $623 million, respectively, of inorganic revenue related to the following:

•  $265 million related to the one-time payment received as a result of the Intellectual Property Agreement entered into with Edwards Lifesciences in April 2023, which is included in the reported results of the Structural Heart & Aortic division of the Cardiovascular portfolio, and

•  $114 million and $358 million, respectively, of inorganic revenue related to the activity noted in (2). The fiscal year organic revenue calculation reclassifies the first nine months of ventilator product line revenue of $138 million from the Other line to the Acute Care and Monitoring division of the Medical Surgical Portfolio.

MEDTRONIC PLC U.S.(1)(2) REVENUE (Unaudited)

FOURTH QUARTER

FISCAL YEAR

REPORTED

ORGANIC

REPORTED

ORGANIC

(in millions)
FY24

FY23

  Growth

Adjusted FY24(4)

AdjustedFY23(5)

Growth

FY24

FY23

Growth

Adjusted FY24(4)

Adjusted FY23(5)

Growth

Cardiovascular
$    1,448

$    1,737

(16.6) %

$    1,448

$    1,472

(1.6) %

$    5,597

$    5,796

(3.4) %

$    5,597

$    5,531

1.2 %

Cardiac Rhythm & Heart Failure
791

819

(3.4)

791

819

(3.4)

3,037

3,052

(0.5)

3,037

3,052

(0.5)

Structural Heart & Aortic
366

625

(41.4)

366

360

1.7

1,453

1,622

(10.4)

1,453

1,357

7.1

Coronary & Peripheral Vascular
291

293

(0.7)

291

293

(0.7)

1,107

1,122

(1.3)

1,107

1,122

(1.3)

Neuroscience
1,692

1,581

7.0

1,692

1,581

7.0

6,305

6,018

4.8

6,305

6,018

4.8

Cranial & Spinal Technologies
936

855

9.5

936

855

9.5

3,495

3,259

7.2

3,495

3,259

7.2

Specialty Therapies
439

422

4.0

439

422

4.0

1,641

1,608

2.1

1,641

1,608

2.1

Neuromodulation
317

304

4.3

317

304

4.3

1,169

1,151

1.6

1,169

1,151

1.6

Medical Surgical
954

919

3.8

954

919

3.8

3,717

3,549

4.7

3,759

3,604

4.3

Surgical & Endoscopy
679

653

4.0

679

653

4.0

2,650

2,541

4.3

2,650

2,541

4.3

Acute Care & Monitoring
275

266

3.4

275

266

3.4

1,067

1,008

5.9

1,109

1,063

4.3

Diabetes
223

199

12.1

223

199

12.1

852

849

0.4

852

849

0.4

Other (3)
26

39

(33.3)

91

160

(43.1)

TOTAL
$    4,343

$    4,476

(3.0) %

$    4,317

$    4,171

3.5 %

$   16,562

$   16,373

1.2 %

$   16,514

$   16,003

3.2 %

(1)
U.S. includes the United States and U.S. territories.

(2)
The data in this schedule has been intentionally rounded to the nearest million and, therefore, may not sum.

(3)
Includes historical operations and ongoing transition agreements from businesses the Company has exited or divested, which primarily includes the Company’s ventilator product line and the Renal Care Solutions (RCS) business.

(4)
The three and twelve months ended April 26, 2024 excludes $26 million and $48 million, respectively, of inorganic revenue related to the activity noted in (3). The fiscal year organic revenue calculation reclassifies the first nine months of ventilator product line revenue of $42 million from the Other line to the Acute Care and Monitoring division of the Medical Surgical Portfolio.

(5)
The three and twelve months ended April 28, 2023 excludes $304 million and $370 million, respectively, of inorganic revenue related to the following:

•  $265 million related to the one-time payment received as a result of the Intellectual Property Agreement entered into with Edwards Lifesciences in April 2023, which is included in the reported results of the Structural Heart & Aortic division of the Cardiovascular portfolio, and

•  $39 million and $105 million, respectively, of inorganic revenue related to the activity noted in (3). The fiscal year organic revenue calculation reclassifies the first nine months of ventilator product line revenue of $55 million from the Other line to the Acute Care and Monitoring division of the Medical Surgical Portfolio.

MEDTRONIC PLC WORLD WIDE REVENUE: GEOGRAPHIC (1)(2) (Unaudited)

FOURTH QUARTER

FISCAL YEAR

REPORTED

ORGANIC

REPORTED

ORGANIC

(in millions)
FY24

FY23

Growth

CurrencyImpact(4)

Adjusted FY24(5)

Adjusted FY23(6)

Growth

FY24

FY23

Growth

CurrencyImpact(4)

Adjusted FY24(5)

AdjustedFY23(6)

Growth

U.S.
$    1,448

$    1,737

(16.6) %

$         —

$    1,448

$    1,472

(1.6) %

$    5,597

$    5,796

(3.4) %

$         —

$    5,597

$     5,531

1.2 %

Non-U.S. Developed
1,039

1,011

2.8

(13)

1,052

1,011

4.1

3,857

3,564

8.2

62

3,795

3,564

6.5

Emerging Markets
643

554

16.1

(15)

658

554

18.8

2,377

2,161

10.0

(49)

2,426

2,161

12.3

Cardiovascular
3,130

3,302

(5.2)

(28)

3,158

3,037

4.0

11,831

11,522

2.7

12

11,819

11,257

5.0

U.S.
1,692

1,581

7.0

1,692

1,581

7.0

6,305

6,018

4.8

6,305

6,018

4.8

Non-U.S. Developed
482

469

2.8

(11)

493

469

5.1

1,739

1,658

4.9

9

1,730

1,658

4.3

Emerging Markets
371

360

3.1

(10)

381

360

5.8

1,362

1,283

6.2

(25)

1,387

1,283

8.1

Neuroscience
2,545

2,410

5.6

(21)

2,566

2,410

6.5

9,406

8,959

5.0

(16)

9,422

8,959

5.2

U.S.
954

919

3.8

954

919

3.8

3,717

3,549

4.7

3,759

3,604

4.3

Non-U.S. Developed
805

799

0.8

(17)

822

799

2.9

3,049

2,917

4.5

20

3,055

2,944

3.8

Emerging Markets
439

405

8.4

(5)

444

405

9.6

1,650

1,522

8.4

(4)

1,697

1,579

7.5

Medical Surgical
2,198

2,124

3.5

(22)

2,220

2,124

4.5

8,417

7,989

5.4

16

8,512

8,127

4.7

U.S.
223

199

12.1

223

199

12.1

852

849

0.4

852

849

0.4

Non-U.S. Developed
337

314

7.3

1

336

314

7.0

1,284

1,106

16.1

37

1,247

1,106

12.7

Emerging Markets
99

82

20.7

(2)

101

82

23.2

352

307

14.7

(6)

358

307

16.6

Diabetes
660

595

10.9

(1)

661

595

11.1

2,488

2,262

10.0

31

2,457

2,262

8.6

U.S.
26

39

(33.3)

91

160

(43.1)

Non-U.S. Developed
11

35

(68.6)

(2)

50

163

(69.3)

(6)

Emerging Markets
21

39

(46.2)

(1)

81

172

(52.9)

(5)

Other (3)
57

114

(50.0)

(3)

221

495

(55.4)

(12)

U.S.
4,343

4,476

(3.0)

4,317

4,171

3.5

16,562

16,373

1.2

16,514

16,003

3.2

Non-U.S. Developed
2,674

2,629

1.7

(42)

2,702

2,593

4.2

9,979

9,408

6.1

121

9,828

9,272

6.0

Emerging Markets
1,572

1,440

9.2

(33)

1,584

1,401

13.1

5,823

5,446

6.9

(89)

5,869

5,330

10.1

TOTAL
$    8,589

$    8,544

0.5 %

$       (75)

$    8,604

$    8,165

5.4 %

$   32,364

$   31,227

3.6 %

$         31

$   32,210

$   30,604

5.2 %

(1)
U.S. includes the United States and U.S. territories. Non-U.S. developed markets include Japan, Australia, New Zealand, Korea, Canada, and the countries of Western Europe. Emerging Markets include the countries of the Middle East, Africa, Latin America, Eastern Europe, and the countries of Asia that are not included in the non-U.S. developed markets, as previously defined.

(2)
The data in this schedule has been intentionally rounded to the nearest million and, therefore, may not sum.

(3)
Includes historical operations and ongoing transition agreements from businesses the Company has exited or divested, which primarily includes the Company’s ventilator product line and the Renal Care Solutions (RCS) business.

(4)
The currency impact to revenue measures the change in revenue between current and prior year periods using constant exchange rates.

(5)
The three and twelve months ended April 26, 2024 excludes $57 million and $111 million, respectively, of inorganic revenue related to the activity noted in (3) and $72 million of unfavorable currency impact and $43 million of favorable currency impact on the remaining segments, respectively. The fiscal year organic revenue calculation reclassifies the first nine months of ventilator product line revenue of $110 million from the Other line to the Acute Care and Monitoring division of the Medical Surgical Portfolio.

(6)
The three and twelve months ended April 28, 2023 excludes $379 million and $623 million, respectively, of inorganic revenue related to the following:

•  $265 million related to the one-time payment received as a result of the Intellectual Property Agreement entered into with Edwards Lifesciences in April 2023, which is included in the reported results of the Structural Heart & Aortic division of the Cardiovascular portfolio, and

•  $114 million and $358 million, respectively, of inorganic revenue related to the activity noted in (3). The fiscal year organic revenue calculation reclassifies the first nine months of ventilator product line revenue of $138 million from the Other line to the Acute Care and Monitoring division of the Medical Surgical Portfolio.

MEDTRONIC PLC CONSOLIDATED STATEMENTS OF INCOME (Unaudited) 

Three months ended

Fiscal year ended

(in millions, except per share data)
April 26, 2024

April 28, 2023

April 26, 2024

April 28, 2023

Net sales
$              8,589

$              8,544

$            32,364

$            31,227

Costs and expenses:

Cost of products sold, excluding amortization of intangible assets
3,044

2,980

11,216

10,719

Research and development expense
675

640

2,735

2,696

Selling, general, and administrative expense
2,765

2,616

10,736

10,415

Amortization of intangible assets
419

423

1,693

1,698

Restructuring charges, net
112

294

226

375

Certain litigation charges, net
44

(30)

149

(30)

Other operating expense (income), net
477

56

464

(131)

Operating profit
1,053

1,565

5,144

5,485

Other non-operating income, net
(4)

(173)

(412)

(515)

Interest expense, net
202

187

719

636

Income before income taxes
856

1,551

4,837

5,364

Income tax provision
196

362

1,133

1,580

Net income
659

1,188

3,705

3,784

Net income attributable to noncontrolling interests
(5)

(9)

(28)

(26)

Net income attributable to Medtronic
$                  654

$              1,179

$              3,676

$              3,758

Basic earnings per share
$                 0.49

$                 0.89

$                 2.77

$                 2.83

Diluted earnings per share
$                 0.49

$                 0.88

$                 2.76

$                 2.82

Basic weighted average shares outstanding
1,322.3

1,330.4

1,327.7

1,329.8

Diluted weighted average shares outstanding
1,325.4

1,332.8

1,330.2

1,332.8

The data in the schedule above has been intentionally rounded to the nearest million, and therefore, the quarterly amounts may not sum to the fiscal year-to-date amounts.

MEDTRONIC PLC GAAP TO NON-GAAP RECONCILIATIONS(1) (Unaudited) 

Three months ended April 26, 2024

(in millions, except per share data)
Net Sales

Cost of ProductsSold

Gross Margin Percent

Operating Profit

Operating Profit Percent

Income Before IncomeTaxes

Net Income attributable to Medtronic

Diluted EPS

Effective Tax Rate

GAAP
$  8,589

$   3,044

64.6 %

$     1,053

12.3 %

$      856

$          654

$     0.49

22.9 %

Non-GAAP Adjustments:

Amortization of intangible assets

419

4.9

419

357

0.27

15.0

Restructuring and associated costs (2)

(13)

0.2

152

1.8

152

125

0.09

17.8

Acquisition and divestiture-related items (3)

(76)

0.9

611

7.1

611

515

0.39

15.9

Certain litigation charges, net

44

0.5

44

37

0.03

15.9

(Gain)/loss on minority investments (4)

195

197

0.15

(1.0)

Medical device regulations (5)

(21)

0.2

31

0.4

31

27

0.02

12.9

Certain tax adjustments, net

17

0.01

Non-GAAP
$  8,589

$   2,934

65.8 %

$     2,311

26.9 %

$    2,309

$       1,929

$     1.46

16.2 %

Currency impact
75

18

0.1

101

0.9

0.07

Currency Adjusted
$  8,664

$   2,952

65.9 %

$     2,412

27.8 %

$     1.53

Three months ended April 28, 2023

(in millions, except per share data)
Net Sales

Cost of Products Sold

GrossMarginPercent

Operating Profit

Operating Profit Percent

IncomeBefore Income Taxes

Net Income attributable to Medtronic

Diluted EPS

Effective Tax Rate

GAAP
$  8,544

$   2,980

65.1 %

$     1,565

18.3 %

$    1,551

$       1,179

$     0.88

23.3 %

Non-GAAP Adjustments:

Amortization of intangible assets

423

5.0

423

361

0.27

14.7

Restructuring and associated costs (2)

(30)

0.4

372

4.4

372

288

0.22

22.6

Acquisition and divestiture-related items (6)

(7)

0.1

139

1.6

139

131

0.10

5.8

Certain litigation charges, net (7)

(30)

(0.4)

(30)

(22)

(0.02)

26.7

(Gain)/loss on minority investments (4)

(10)

(7)

(0.01)

(20.0)

Medical device regulations (5)

(25)

0.3

44

0.5

44

34

0.03

22.7

Certain tax adjustments, net (8)

127

0.10

Non-GAAP
$  8,544

$   2,917

65.9 %

$     2,512

29.4 %

$    2,488

$       2,091

$     1.57

15.8 %

See description of non-GAAP financial measures contained in the press release dated May 23, 2024.

(1)
The data in this schedule has been intentionally rounded to the nearest million or $0.01 for EPS figures, and, therefore, may not sum.

(2)
Associated costs include costs incurred as a direct result of the restructuring program, such as salaries for employees supporting the program, consulting expenses, and asset write-offs.

(3)
The charges predominantly include $439 million of charges related to the February 20, 2024 decision to exit the Company’s ventilator product line, which primarily includes long-lived intangible asset impairments and inventory write-downs. In addition, other charges primarily consist of changes in fair value of contingent consideration.

(4)
We exclude unrealized and realized gains and losses on our minority investments as we do not believe that these components of income or expense have a direct correlation to our ongoing or future business operations.

(5)
The charges represent incremental costs of complying with the new European Union medical device regulations for previously registered products and primarily include charges for contractors supporting the project and other direct third-party expenses. We consider these costs to be duplicative of previously incurred costs and/or one-time costs, which are limited to a specific period.

(6)
The charges primarily include changes in the carrying value of the disposal group and other associated costs as a result of the April 2023 sale of half of the Company’s Renal Care Solutions (RCS) business, changes in fair value of contingent consideration, business combination costs, and associated costs related to the previously contemplated separation of the PMRI businesses.

(7)
Certain litigation includes $35 million related to the one-time payment received as a result of the Intellectual Property Agreement entered into with Edwards Lifesciences in April 2023.

(8)
The charge primarily relates to the reduction of deferred tax assets due to the disallowance of certain interest deductions and the change in the reporting currency for certain carryover attributes, and the impact from the sale of half of the Company’s RCS business.

MEDTRONIC PLC GAAP TO NON-GAAP RECONCILIATIONS(1) (Unaudited) 

Fiscal year ended April 26, 2024

(in millions, except per share data)
Net Sales

Cost of Products Sold

GrossMarginPercent

OperatingProfit

Operating Profit Percent

IncomeBeforeIncome Taxes

Net Income attributable toMedtronic

DilutedEPS

Effective Tax Rate

GAAP
$  32,364

$  11,216

65.3 %

$     5,144

15.9 %

$    4,837

$         3,676

$     2.76

23.4 %

Non-GAAP Adjustments:

Amortization of intangible assets

1,693

5.2

1,693

1,435

1.08

15.2

Restructuring and associated costs (2)

(55)

0.2

389

1.2

389

323

0.24

17.0

Acquisition and divestiture-related items (3)

(100)

0.3

777

2.4

777

664

0.50

14.5

Certain litigation charges

149

0.5

149

118

0.09

20.8

(Gain)/loss on minority investments (4)

308

305

0.23

0.6

Medical device regulations (5)

(81)

0.3

119

0.4

119

97

0.07

18.5

Certain tax adjustments, net (6)

299

0.22

Non-GAAP
$  32,364

$  10,980

66.1 %

$     8,272

25.6 %

$    8,273

$         6,918

$     5.20

16.0 %

Currency impact
(31)

(114)

0.3

507

1.6

0.33

Currency Adjusted
$  32,333

$  10,866

66.4 %

$     8,779

27.2 %

$     5.53

Fiscal year ended April 28, 2023

(in millions, except per share data)
Net Sales

Cost of Products Sold

Gross Margin Percent

OperatingProfit

OperatingProfit Percent

Income BeforeIncomeTaxes

Net Income attributable to Medtronic

Diluted EPS

Effective Tax Rate

GAAP
$  31,227

$  10,719

65.7 %

$     5,485

17.6 %

$    5,364

$         3,758

$     2.82

29.5 %

Non-GAAP Adjustments:

Amortization of intangible assets

1,698

5.4

1,698

1,443

1.08

15.0

Restructuring and associated costs (2)

(97)

0.3

647

2.1

647

507

0.38

21.5

Acquisition and divestiture-related items (7)

(66)

0.2

345

1.1

345

316

0.24

8.4

Certain litigation charges, net (8)

(30)

(0.1)

(30)

(23)

(0.02)

26.7

(Gain)/loss on minority investments (4)

(33)

(29)

(0.02)

(6.1)

Medical device regulations (5)

(88)

0.3

150

0.5

150

120

0.09

20.0

Debt redemption premium and other charges (9)

53

42

0.03

20.8

Certain tax adjustments, net (10)

910

0.68

Non-GAAP
$  31,227

$  10,469

66.5 %

$     8,295

26.6 %

$    8,194

$         7,045

$     5.29

13.8 %

See description of non-GAAP financial measures contained in the press release dated May 23, 2024.

(1)
The data in this schedule has been intentionally rounded to the nearest million or $0.01 for EPS figures, and, therefore, may not sum.

(2)
Associated costs include costs incurred as a direct result of the restructuring program, such as salaries for employees supporting the program, consulting expenses, and asset write-offs.

(3)
The charges predominantly include $439 million of charges related to the February 20, 2024 decision to exit the Company’s ventilator product line, which primarily includes long-lived intangible asset impairments and inventory write-downs. In addition, other charges primarily consist of changes in fair value of contingent consideration and associated costs related to the previously contemplated separation of the PMRI businesses.

(4)
We exclude unrealized and realized gains and losses on our minority investments as we do not believe that these components of income or expense have a direct correlation to our ongoing or future business operations.

(5)
The charges represent incremental costs of complying with the new European Union medical device regulations for previously registered products and primarily include charges for contractors supporting the project and other direct third-party expenses. We consider these costs to be duplicative of previously incurred costs and/or one-time costs, which are limited to a specific time period.

(6)
The net charge primarily relates to an income tax reserve adjustment associated with the June 2023, Israeli Central-Lod District Court decision and the establishment of a valuation allowance against certain net operating losses which were partially offset by a benefit from the change in a Swiss Cantonal tax rate associated with previously established deferred tax assets from intercompany intellectual property transactions and the step up in tax basis for Swiss Cantonal purposes.

(7)
The charges predominantly include non-cash pre-tax impairments, primarily related to goodwill, changes in the carrying value of the disposal group, and other associated costs, as a result of the April 2023 sale of half of the Company’s Renal Care Solutions (RCS) business; business combination costs, and associated costs related to the previously contemplated separation of the PMRI businesses.

(8)
Certain litigation includes $35 million income related to the one-time payment received as a result of the Intellectual Property Agreement entered into with Edwards Lifesciences in April 2023.

(9)
The charges relate to the early redemption of approximately $2.3 billion of debt and were recorded within interest expense, net within the consolidated statements of income.

(10)
The charge primarily relates to a $764 million reserve adjustment that was a direct result of the U.S. Tax Court opinion, issued in August 2022, on the previously disclosed litigation regarding the allocation of income between Medtronic, Inc. and its wholly owned subsidiary operating in Puerto Rico. Additional charges relate to the reduction of deferred tax assets due to the disallowance of certain interest deductions and the change in the reporting currency for certain carryover attributes, and the amortization on previously established deferred tax assets from intercompany intellectual property transactions.

MEDTRONIC PLC GAAP TO NON-GAAP RECONCILIATIONS(1) (Unaudited) 

Three months ended April 26, 2024

(in millions)
Net Sales

SG&A Expense

SG&A Expense as a % of Net Sales

R&DExpense

R&D Expense as a % of Net Sales

Other Operating(Income) Expense, net

Other Operating(Inc.)/Exp., net as a %of Net Sales

Other Non-OperatingIncome, net

GAAP
$      8,589

$     2,765

32.2 %

$       675

7.9 %

$         477

5.6 %

$             (4)

Non-GAAP Adjustments:

Restructuring and associated costs (2)

(28)

(0.3)

Acquisition and divestiture-related items (3)

(6)

(0.1)

(530)

(6.2)

Medical device regulations (4)

(1)

(9)

(0.1)

(Gain)/loss on minority investments (5)

(195)

Non-GAAP
$      8,589

$     2,731

31.8 %

$       666

7.8 %

$         (52)

(0.6) %

$          (200)

Fiscal year ended April 26, 2024

(in millions)
Net Sales

SG&AExpense

SG&A Expenseas a % of Net Sales

R&DExpense

R&D Expenseas a % of Net Sales

Other Operating(Income) Expense, net

Other Operating(Inc.)/Exp., net as a % of Net Sales

Other Non-Operating Income, net

GAAP
$    32,364

$   10,736

33.2 %

$    2,735

8.5 %

$         464

1.4 %

$          (412)

Non-GAAP Adjustments:

Restructuring and associated costs (2)

(108)

(0.3)

Acquisition and divestiture-related items (3)

(71)

(0.2)

(606)

(1.9)

Medical device regulations (4)

(2)

(36)

(0.1)

(Gain)/loss on minority investments (5)

(308)

Non-GAAP
$    32,364

$   10,555

32.6 %

$    2,698

8.3 %

$       (141)

(0.4) %

$          (720)

See description of non-GAAP financial measures contained in the press release dated May 23, 2024.

(1)
The data in this schedule has been intentionally rounded to the nearest million, and, therefore, may not sum.

(2)
Associated costs include costs incurred as a direct result of the restructuring program, such as salaries for employees supporting the program and consulting expenses.

(3)
The charges predominantly include $439 million of charges related to the February 20, 2024 decision to exit the Company’s ventilator product line, which primarily includes long-lived intangible asset impairments. In addition, other charges primarily related to changes in fair of contingent consideration and associated costs related to the previously contemplated separation of the PMRI businesses.

(4)
The charges represent estimated incremental costs of complying with the new European Union medical device regulations for previously registered products and primarily include charges for contractors supporting the project and other direct third-party expenses. We consider these costs to be duplicative of previously incurred costs and/or one-time costs, which are limited to a specific time period.

(5)
We exclude unrealized and realized gains and losses on our minority investments as we do not believe that these components of income or expense have a direct correlation to our ongoing or future business operations.

MEDTRONIC PLC GAAP TO NON-GAAP RECONCILIATIONS(1) (Unaudited)

Fiscal Year

(in millions)
2024

2023

2022

Net cash provided by operating activities
$                      6,787

$                      6,039

$                      7,346

Additions to property, plant, and equipment
(1,587)

(1,459)

(1,368)

Free Cash Flow (2)
$                      5,200

$                      4,580

$                      5,978

See description of non-GAAP financial measures contained in the press release dated May 23, 2024.

(1)
The data in this schedule has been intentionally rounded to the nearest million, and therefore, may not sum.

(2)
Free cash flow represents operating cash flows less property, plant, and equipment additions.

MEDTRONIC PLC CONSOLIDATED BALANCE SHEETS (Unaudited)

(in millions)

April 26, 2024

April 28, 2023

ASSETS

Current assets:

Cash and cash equivalents

$               1,284

$               1,543

Investments

6,721

6,416

Accounts receivable, less allowances and credit losses of $173 and $176, respectively

6,128

5,998

Inventories, net

5,217

5,293

Other current assets

2,584

2,425

Total current assets

21,935

21,675

Property, plant, and equipment, net

6,131

5,569

Goodwill

40,986

41,425

Other intangible assets, net

13,225

14,844

Tax assets

3,657

3,477

Other assets

4,047

3,959

Total assets

$             89,981

$             90,948

LIABILITIES AND EQUITY

Current liabilities:

Current debt obligations

$               1,092

$                     20

Accounts payable

2,410

2,662

Accrued compensation

2,375

1,949

Accrued income taxes

1,330

840

Other accrued expenses

3,582

3,581

Total current liabilities

10,789

9,051

Long-term debt

23,932

24,344

Accrued compensation and retirement benefits

1,101

1,093

Accrued income taxes

1,859

2,360

Deferred tax liabilities

515

708

Other liabilities

1,365

1,727

Total liabilities

39,561

39,283

Commitments and contingencies

Shareholders’ equity:

Ordinary shares— par value $0.0001, 2.6 billion shares authorized, 1,311,337,531 and 1,330,809,036 shares issued and outstanding, respectively

Additional paid-in capital

23,129

24,590

Retained earnings

30,403

30,392

Accumulated other comprehensive loss

(3,318)

(3,499)

Total shareholders’ equity

50,214

51,483

Noncontrolling interests

206

182

Total equity

50,420

51,665

Total liabilities and equity

$             89,981

$             90,948

The data in this schedule has been intentionally rounded to the nearest million, and, therefore, may not sum.

MEDTRONIC PLC CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)

Fiscal Year

(in millions)
2024

2023

2022

Operating Activities:

Net income
$           3,705

$           3,784

$           5,062

Adjustments to reconcile net income to net cash provided by operating activities:

Depreciation and amortization
2,647

2,697

2,707

Provision for credit losses
90

73

58

Deferred income taxes
(508)

(226)

(604)

Stock-based compensation
393

355

359

Loss on debt extinguishment

53

Asset impairments and inventory write-downs
371

515

Other, net
573

270

138

Change in operating assets and liabilities, net of acquisitions and divestitures:

Accounts receivable, net
(391)

(576)

(477)

Inventories, net
(139)

(939)

(560)

Accounts payable and accrued liabilities
391

696

213

Other operating assets and liabilities
(345)

(148)

(65)

Net cash provided by operating activities
6,787

6,039

7,346

Investing Activities:

Acquisitions, net of cash acquired
(211)

(1,867)

(91)

Additions to property, plant, and equipment
(1,587)

(1,459)

(1,368)

Purchases of investments
(7,748)

(7,514)

(9,882)

Sales and maturities of investments
7,441

7,343

9,692

Other investing activities, net
(261)

4

(10)

Net cash used in investing activities
(2,366)

(3,493)

(1,659)

Financing Activities:

Change in current debt obligations, net
1,073

Proceeds from short-term borrowings (maturities greater than 90 days)

2,284

Repayments from short-term borrowings (maturities greater than 90 days)

(2,279)

Issuance of long-term debt

5,409

Payments on long-term debt

(6,012)

(1)

Dividends to shareholders
(3,666)

(3,616)

(3,383)

Issuance of ordinary shares
284

308

429

Repurchase of ordinary shares
(2,138)

(645)

(2,544)

Other financing activities
(3)

(409)

163

Net cash used in financing activities
(4,450)

(4,960)

(5,336)

Effect of exchange rate changes on cash and cash equivalents
(230)

243

(231)

Net change in cash and cash equivalents
(259)

(2,171)

121

Cash and cash equivalents at beginning of period
1,543

3,714

3,593

Cash and cash equivalents at end of period
$           1,284

$           1,543

$           3,714

Supplemental Cash Flow Information

Cash paid for:

Income taxes
$           1,622

$           1,548

$               996

Interest
826

606

540

The data in this schedule has been intentionally rounded to the nearest million, and, therefore, may not sum.

About MedtronicBold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, 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 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 on X and LinkedIn.FORWARD LOOKING STATEMENTSThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties, including risks related to competitive factors, difficulties and delays inherent in the development, manufacturing, marketing and sale of medical products, government regulation, geopolitical conflicts, general economic conditions, and other risks and uncertainties described in the company’s periodic reports on file with the U.S. Securities and Exchange Commission including the most recent Annual Report on Form 10-K of the company. In some cases, you can identify these statements by forward-looking words or expressions, such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “looking ahead,” “may,” “plan,” “possible,” “potential,” “project,” “should,” “going to,” “will,” and similar words or expressions, the negative or plural of such words or expressions and other comparable terminology. Actual results may differ materially from anticipated results. Medtronic does not undertake to update its forward-looking statements or any of the information contained in this press release, including to reflect future events or circumstances.NON-GAAP FINANCIAL MEASURESThis press release contains financial measures, including adjusted net income, adjusted diluted EPS, and organic revenue, which are considered “non-GAAP” financial measures under applicable SEC rules and regulations. References to quarterly or annual figures increasing, decreasing or remaining flat are in comparison to fiscal year 2023.Medtronic management believes that non-GAAP financial measures provide information useful to investors in understanding the company’s underlying operational performance and trends and to facilitate comparisons with the performance of other companies in the med tech industry. Non-GAAP net income and diluted EPS exclude the effect of certain charges or gains that contribute to or reduce earnings but that result from transactions or events that management believes may or may not recur with similar materiality or impact to operations in future periods (Non-GAAP Adjustments). Medtronic generally uses non-GAAP financial measures to facilitate management’s review of the operational performance of the company and as a basis for strategic planning. Non-GAAP financial measures should be considered supplemental to and not a substitute for financial information prepared in accordance with U.S. generally accepted accounting principles (GAAP), and investors are cautioned that Medtronic may calculate non-GAAP financial measures in a way that is different from other companies. Management strongly encourages investors to review the company’s consolidated financial statements and publicly filed reports in their entirety. Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the financial schedules accompanying this press release.Medtronic calculates forward-looking non-GAAP financial measures based on internal forecasts that omit certain amounts that would be included in GAAP financial measures. For instance, forward-looking organic revenue growth guidance excludes the impact of foreign currency fluctuations, as well as significant acquisitions or divestitures. Forward-looking diluted non-GAAP EPS guidance also excludes other potential charges or gains that would be recorded as Non-GAAP Adjustments to earnings during the fiscal year. Medtronic does not attempt to provide reconciliations of forward-looking non-GAAP EPS guidance to projected GAAP EPS guidance because the combined impact and timing of recognition of these potential charges or gains is inherently uncertain and difficult to predict and is unavailable without unreasonable efforts. In addition, the company believes such reconciliations would imply a degree of precision and certainty that could be confusing to investors. Such items could have a substantial impact on GAAP measures of financial performance.

Contacts:

Erika Winkels           
Ryan Weispfenning

Public Relations       
Investor Relations

+1-763-526-8478     
+1-763-505-4626

SOURCE Medtronic plc

Orchestra BioMed to Participate in Jefferies Global Healthcare Conference

NEW HOPE, Pa., May 22, 2024 (GLOBE NEWSWIRE) — 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 company management will present and be available for one-on-one meetings at the Jefferies Global Healthcare Conference being held in New York, NY, June 4-6, 2024. Details of the presentation are below. Format: Fireside Chat Date: Wednesday, June 5, 2024 Time: 4:00 PM ET (Track 1) Webcast: https://wsw.com/webcast/jeff302/obio/1835536 A replay of the webcast will be available on the Events section of the Orchestra BioMed website for 90 days following the presentation. About Orchestra BioMedOrchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed’s lead product candidate is atrioventricular interval modulation (AVIM) therapy (also known as BackBeat Cardiac Neuromodulation Therapy (CNT™)) for the treatment of hypertension, a significant risk factor for death worldwide. Orchestra BioMed is also developing Virtue® Sirolimus AngioInfusion™ Balloon (SAB) for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of AVIM therapy for the treatment of hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. Investor Contact:Bob YedidLifeSci Advisors516-428-8577Bob@lifesciadvisors.com   Media Contact:Kelsey Kirk-EllisOrchestra BioMed484-682-4892Kkirkellis@orchestrabiomed.com

CVRx to Present at the William Blair 44th Annual Growth Stock Conference

MINNEAPOLIS, May 22, 2024 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company, today announced that the management team will present at the William Blair 44th Annual Growth Stock Conference on Wednesday, June 5, 2024. The Company is scheduled to present at 8:40am Central Time the same day via webcast. A live audio webcast of the conference presentation will be available online at the investor relations page of the Company’s website at ir.cvrx.com. About CVRx, Inc. CVRx is focused on the development and commercialization of the Barostim™ System, the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. Baroreceptors activate the body’s baroreflex, which in turn triggers an autonomic response to the heart. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has also received the CE Mark for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com. Investor Contact: Mark Klausner or Mike VallieICR Westwicke443-213-0501ir@cvrx.com Media Contact: Laura O’NeillFinn Partners402-499-8203laura.oneill@finnpartners.com

Novo Nordisk Foundation and Technical University of Denmark press release: Bacteria in our gut could play a role in cardiometabolic disease: A new initiative aims to find out

A new Denmark-based research initiative aims to establish a potential causal link between the gut microbiome – the combined genetic material of the communities of bacteria and other microbes in the human gut – and the development of cardiometabolic diseases (CMD) such as obesity, type 2 diabetes, and cardiovascular disease. The goal is to generate knowledge that can lead to new prevention or treatment options for people living with, or at risk of, CMD.
COPENHAGEN, Denmark, May 22, 2024 /PRNewswire/ — The Novo Nordisk Foundation has committed DKK 150 million (USD 22 million) for the first phase of the Microbiome Health Initiative, a virtual research centre anchored at the Technical University of Denmark (DTU), north of Copenhagen. Professor Fredrik Bäckhed from the University of Gothenburg will be employed part-time at DTU to lead the initiative, with Professor Tine Rask Licht from DTU National Food Institute as co-Director.
Research has already shown associations between several gut bacteria or metabolites – substances produced by microbes – and CMD. In Phase 1, the initiative will therefore focus on collaborative research projects that investigate the specific effects of these bacteria or metabolites and advance understanding on how microbiome interventions could reduce the risk of CMD or help manage it. This phase will run from 2024-2028.
“Our task is to verify a causal connection between the intestinal microbiome and diseases such as cardiovascular disease and diabetes,” says Professor Licht.
“These links have been partially elucidated in laboratory trials and animal experiments, but there is yet no solid evidence of causal relationships in humans. Once we have this knowledge, the next step in the project will be to find and develop new strategies to treat or prevent these major diseases. Such new strategies will rely on modification of our gut microbiome, for example by adding new microbes, or new dietary components.”
The initiative also involves leading scientists at the University of Copenhagen, Amsterdam University Medical Centre, and the Weizmann Institute of Science in Israel, and clinicians at Odense University Hospital and Steno Diabetes Centre Copenhagen. Together, they cover a broad range of disciplines, including microbial physiology, bioinformatics, aetiology of CMD, and human interventions.
While DTU’s strength in the project is research into the impact of diet on the structure and activity of the human microbiome, the other research centres in the initiative have extensive expertise in CMD research, microbiome research, and translation into clinical settings.
“The interdisciplinary approach of the project makes it possible to coordinate research between the strongest international environments,” says Professor Bäckhed. “It is unique that we can coordinate efforts between universities and hospitals to develop the most promising treatment concepts.”
‘A whole new set of tools’Despite major advances in research and treatment, the prevalence of CMD has doubled in the last 30 years. This group of conditions – including obesity and type 2 diabetes – and associated complications such as heart attack and stroke are now the leading cause of death worldwide.
Also in the last years, advances in microbiome research have led to new understanding regarding the impact of microbes and their metabolic output on human physiology, immunity, and disease processes. In the case of CMD, evidence strongly suggests that the gut microbiome – partly due to the metabolites the microbes produce – plays a critical role, and that by making small changes, individuals could reduce their risk of, for example, developing diabetes or suffering a heart attack. This initiative aims to generate significant new knowledge that, in the future, could lead to approved microbiome-based solutions such as supplements or improved dietary guidance to prevent or treat CMD.
“The Danish microbiome research field is strong but, in order to take the critical next steps, we need an ambitious, interdisciplinary approach that also includes leading international experts,” says Birgitte Holst, Scientific Director in Medical Science at the Novo Nordisk Foundation.
“If this initiative succeeds in establishing a causal link between the microbiome and CMD, it could lead to a whole new set of tools for managing these devastating diseases and help resolve a major global health challenge.”
Phase 2, which is subject to approval following a mid-term evaluation of Phase 1, would run from 2026-2030. In this phase, the initiative would support human intervention studies and invest in infrastructure to support the development of microbes, microbial compounds, or targeted supplements for therapeutic purposes.
Editor’s Notes
About DTU National Food Institute
DTU National Food Institute conducts research into and disseminates – through advice, innovation and teaching – sustainable and value-creating solutions in the area of food and health for the benefit of society. The DTU National Food institute’s vision is to make a difference by generating future prosperity through research into food and health. The institute prevents disease and promotes health, develops new and better food products for a growing population and creates sustainable technological solutions. The institute’s tasks are carried out in a unique interdisciplinary cooperation in e.g. nutrition, chemistry, toxicology, microbiology, epidemiology, modelling and technology.
About the Novo Nordisk Foundation
Established in Denmark in 1924, the Novo Nordisk Foundation is an enterprise foundation with philanthropic objectives. The vision of the Foundation is to improve people’s health and the sustainability of society and the planet. The Foundation’s mission is to progress research and innovation in the prevention and treatment of cardiometabolic and infectious diseases as well as to advance knowledge and solutions to support a green transformation of society.
www.novonordiskfonden.dk/en
SOURCE Novo Nordisk Foundation

LeMaitre to Present at the Jefferies Global Healthcare Conference

BURLINGTON, Mass., May 21, 2024 (GLOBE NEWSWIRE) — LeMaitre Vascular, Inc. (Nasdaq:LMAT) announced today that George W. LeMaitre, Chairman & CEO, will present at the 2024 Jefferies Global Healthcare Conference on Thursday, June 6, 2024, at 11:00 AM ET at the Marriott Marquis in New York City. About LeMaitre LeMaitre is a provider of devices, implants and services for the treatment of peripheral vascular disease, a condition that affects more than 200 million people worldwide. The Company develops, manufactures and markets disposable and implantable vascular devices to address the needs of its core customer, the vascular surgeon. Additional information can be found at www.lemaitre.com.

BioCardia Announces Reverse Stock Split

SUNNYVALE, Calif., May 21, 2024 (GLOBE NEWSWIRE) — BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that, following approval by the Company’s stockholders and its Board of Directors, the Company intends to effect a reverse stock split of its common stock at a ratio of 1 post-split share for every 15 pre-split shares. The reverse stock split will become effective at 12:01 a.m. Eastern Daylight Time on Thursday, May 30, 2024. The Company’s common stock will begin trading on a split-adjusted basis when the market opens on Thursday, May 30, 2024. The Company’s common stock and warrants will continue to be traded on The Nasdaq Capital Market under the ticker symbols “BCDA” and “BCDAW,” respectively. The reverse stock split is intended to increase the minimum bid price requirement for continued listing on The Nasdaq Capital Market. The Company, however, cannot assure that the price of its common stock after the reverse stock split will reflect the corresponding split ratio, that the price per share following the effective time will be maintained for any period of time, or that the price will remain above the pre-split trading price. At the effective time of the reverse stock split, every 15 shares of the Company’s issued and outstanding common stock will be converted automatically into one issued and outstanding share of common stock. Stockholders holding their shares electronically in book-entry form are not required to take any action to receive post-split shares. Stockholders owning shares through a bank, broker, or other nominee will have their positions automatically adjusted to reflect the reverse stock split, subject to brokers’ particular processes, and will not be required to take any action in connection with the reverse stock split. For those stockholders holding physical stock certificates, the Company’s transfer agent, Continental Stock Transfer & Trust Co., will send instructions for exchanging those certificates for shares held electronically in book-entry form or for new certificates, in either case representing the post-split number of shares, and any payments in cash in lieu of fractional shares, if applicable. The reverse stock split will affect all stockholders uniformly and will not alter any stockholder’s percentage interest in the Company’s equity, except to the extent that the reverse stock split would result in a stockholder owning a fractional share. No fractional shares will be issued in connection with the reverse stock split. Stockholders who would otherwise hold a fractional share of the Company’s common stock following the reverse stock split will receive a cash payment in lieu thereof at a price equal to that fractional share to which the stockholder would otherwise be entitled multiplied by the closing sale price of the common stock on The Nasdaq Capital Market, as adjusted for the reverse stock split, May 29, 2024. Proportional adjustments will be made to the number of shares of common stock issuable upon exercise or conversion of the Company’s equity awards and warrants, the applicable exercise or conversion price and the number of shares issuable under the Company’s equity plans. Following the reverse stock split, the Company’s common stock will have a new CUSIP number (09060U 606). The CUSIP number for the Company’s public warrants will not change. In connection with the reverse stock split, the Company will effect an adjustment to its authorized shares of common stock, such that the 100,000,000 authorized shares of common stock will be reduced to 50,000,000 authorized shares of common stock. The par value per share of common stock and number of authorized shares of preferred stock will not change. Additional information about the reverse stock split can be found in the Company’s definitive proxy statement filed with the SEC on April 15, 2024, which is available free of charge at the SEC’s website, www.sec.gov, and on the Company’s website at https://www.biocardia.com/investors/finanicals-filings/id/1021.   About BioCardia® BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP autologous and CardiALLO allogeneic cell therapies are the Company’s biotherapeutic platforms for the treatment of heart disease. BioCardia also works with partners to provide its proprietary biotherapeutic delivery system along with preclinical and clinical development services for biotherapeutic delivery to the heart. Forward Looking Statements: This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, statements regarding the timing and effectiveness of the reverse stock split and the Company’s ability to regain compliance with Nasdaq’s minimum bid price. These forward-looking statements are made as of the date of this press release. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. Factors that could cause or contribute to such differences include, but are not limited to, the Company’s liquidity position and its ability to raise additional funds, as well as the Company’s ability to successfully advance its clinical trials. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 29, 2023, under the caption titled “Risk Factors,” and in its subsequently filed Quarterly Reports on Form 10-Q. The Company expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

BioSig Technologies Chief Executive Officer Mr. Anthony Amato Issues the Following Letter to Shareholders

Westport, CT, May 21, 2024 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or “Company”), a medical technology company delivering unprecedented accuracy and precision to intra-cardiac signal visualization, has today issued the following Letter to Shareholders: Dear Shareholders, As the new CEO of BioSig, I am committed to keeping our shareholders updated to the best of my ability on the progress of our Company. Our new management team is firmly committed to both restoring and creating lasting shareholder value and we believe our recent progress is the beginning of a successful foundation for growth. Over the past two months, BioSig has realized important and material progress with respect to several corporate initiatives. The Company is pleased to introduce its newly assembled Board of Directors, comprised of five highly qualified and talented individuals with decades of experience in their respective fields, including three independent directors, and the Company has fully constituted each committee of the Board of Directors (Audit, Compensation, and Nominating and Corporate Governance). The Company is also in the process of assembling a revamped Business Advisory Board, which will evaluate specific business opportunities as well as possible mergers & acquisitions. It is the Company’s strong belief that by attracting quality people, the best results will be achieved. While the Company’s operations were impacted for a brief period by the changes in both the CEO position and the Board, the Company continues to focus on its core business, the ongoing operations of its PURE EP™ Biomedical Signal Processing Technology. The Company still maintains active partnerships with some of the largest well-known institutions in the electrophysiology space.  The Company is working with great urgency to demonstrate the value proposition of its internal PURE EP platform, to both its stakeholders and shareholders. In addition, the Company believes that it has compelling opportunities with other owned assets including, but not limited to, the Artificial Intelligence (“AI”) space, specifically relating to generative data compilation and potential commercialization through proprietary algorithms specific to the interventional cardiology sector. The Company, during the summer of 2023, issued a number of press releases relating to AI initiatives and potential partnerships. The Company owns multiple assets that management is currently working towards potential monetization. Additionally, the Company presented to the Nasdaq Hearings Panel on Tuesday, May 7, 2024 as was previously disclosed to shareholders.  Representing the Company was a top advisory firm well known for working on Nasdaq compliance matters.  Prior to the hearing, the Company was informed by Nasdaq Listing Qualifications staff that it had regained compliance with the minimum bid price requirement as set forth in Listing Rule 5550(a)(2).  The Company addressed, at the hearing, the remaining compliance issues and will update shareholders once the Company receives further communication from the Nasdaq Panel. I want to reiterate my commitment to restoring shareholder value and will work tirelessly to achieve specific goals I set prior to accepting the CEO position. I want to thank our supportive shareholders for their patience and understanding as we move forward. Sincerely, Anthony AmatoChief Executive Officer About BioSig Technologies, Inc. (NASDAQ: BSGM) BioSig Technologies is a medical technology company focused on deciphering the body’s electrical signals, starting with heart rhythms. By leveraging a first of its kind combination of hardware and software, we deliver unprecedented cardiac signal clarity, ending the reliance on ‘mixed signals’ and ‘reading between the lines.’ Our platform technology is addressing some of healthcare’s biggest challenges—saving time, saving costs, and saving lives. The Company’s product, the PURE EP™ Platform, an FDA 510(k) cleared non-invasive class II device, provides superior, real-time signal visualization allowing physicians to perform highly targeted cardiac ablation procedures with increased procedural efficiency and efficacy. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) BioSig’s ability to regain compliance with and meet the continued listing requirements of the Nasdaq Capital Market to maintain listing of its common stock; (ii) our cost reduction plan and associated workforce reduction or other cost-saving measures not reaching the targeted reduction of cash burn by 50%; (iii) the geographic, social, and economic impact of pandemics or worldwide health issues on BioSig’s ability to conduct its business and raise capital in the future when needed; (iv) BioSig’s inability to manufacture its products and product candidates on a commercial scale on its own, or in collaboration with third parties; (v) difficulties in obtaining financing on commercially reasonable terms; (vi) changes in the size and nature of BioSig’s competition; (vii) loss of one or more key executives or scientists; and (viii) difficulties in securing regulatory approval to market BioSig’s products and product candidates. For a discussion of other risks and uncertainties, and other important factors, any of which could cause BioSig’s actual results to differ from those contained in forward-looking statements, see Biosig’s filings with the Securities and Exchange Commission (“SEC”), including the section titled “Risk Factors” in BioSig’s Quarterly Report on Form 10-Q, filed with the SEC on May 20, 2024. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise, except as required by law.

Element Science Appoints Lee Smith, Jr. as the Company’s First Head of Commercial

SAN FRANCISCO–(BUSINESS WIRE)–Element Science, an innovative health technology company developing a pioneering digital wearable platform for high-risk cardiovascular patients, announced the appointment of Lee Smith Jr. as the company’s first Head of Commercial. With nearly 20 years of successful leadership experience in sales, commercial operations, and customer success, Mr. Smith […]

Circle Cardiovascular Imaging Partners with inHEART to Distribute AI-Driven Digital Twin of the Heart for Advanced Cardiac Procedural Planning in the Electrophysiology Lab

BOSTON, May 16, 2024 /PRNewswire/ — Heart Rhythm Society (HRS) Conference — Circle Cardiovascular Imaging Inc. and inHEART Inc. announced today a global distribution agreement enabling Circle to promote and market inHEART’s advanced, AI-enabled digital twin of the heart through Circle’s…