Thermo Fisher Scientific Reports Second Quarter 2022 Results

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today reported its financial results for the second quarter ended July 2, 2022.

Second Quarter 2022 Highlights

  • Second quarter revenue was $10.97 billion.
  • Second quarter GAAP diluted earnings per share (EPS) was $4.22.
  • Second quarter adjusted EPS was $5.51.
  • Delivered very strong financial results in the second quarter, with 13% Core organic revenue growth and $0.63 billion of COVID-19 testing revenue.
  • Launched a range of high-impact innovative new products including the Gibco CTS TrueCut Cas9 Protein to advance genomic research by delivering consistently higher editing efficiency across a wide range of gene targets and cell types, and the Phadia 2500+ series of instruments launched in the U.S., to provide high throughput testing for both allergy diagnostics and autoimmune diseases. At the American Society for Mass Spectrometry (ASMS) Conference, the company featured new instruments, workflows, software, and industry collaborations enabling customers to generate new analytical insights, enhance productivity, and accelerate next generation vaccine and therapy development. Highlights included the Thermo Scientific Direct Mass Technology which advances the capability to analyze the characteristics of biotherapeutics, and the Thermo Scientific AccelerOme Automated Sample Preparation Platform which significantly simplifies workflows for proteomic researchers by eliminating a range of previously manual steps.
  • Strengthened our unique customer value proposition with new capacity and capabilities to meet increasing global demand: in Grand Island, NY expanded cell culture media capacity to support research and drug production applications; and in Geel, Belgium expanded our European distribution center for our laboratory chemicals business.
  • Continued to leverage our scale in high growth and emerging markets, delivering excellent growth in China, driven by both our Core business and our role in supporting local COVID-19 testing.

"We delivered another quarter of outstanding financial performance," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "Our proven growth strategy and PPI Business System enabled us to deliver exceptional results across our business and we continue to see the benefit of our strategic investments to enhance our unique customer value proposition. The integration of our clinical research business is going very well, the business is performing at a high level and the outlook for long-term synergies is very compelling."

Casper added, "Our team continues to execute well and we're in a very strong position at the halfway point of the year and on track to deliver another outstanding year for Thermo Fisher."

Second Quarter 2022
Revenue for the quarter grew 18% to $10.97 billion in 2022. Organic revenue growth was 3%; acquisitions increased revenue by 19% and currency translation decreased revenue by 4%. Core organic revenue growth was 13%. COVID-19 testing revenue was $0.63 billion.

GAAP Earnings Results

GAAP diluted EPS in the second quarter of 2022 was $4.22, versus $4.61 in the same quarter last year. GAAP operating income for the second quarter of 2022 was $2.00 billion, compared with $2.16 billion in the year-ago quarter. GAAP operating margin was 18.2%, compared with 23.3% in the second quarter of 2021.

Non-GAAP Earnings Results

Adjusted EPS in the second quarter of 2022 was $5.51, versus $5.60 in the second quarter of 2021. Adjusted operating income for the second quarter of 2022 was $2.61 billion, compared with $2.69 billion in the year-ago quarter. Adjusted operating margin was 23.7%, compared with 29.0% in the second quarter of 2021.

Annual Guidance for 2022

The company will provide updated 2022 financial guidance during its earnings conference call this morning at 8:30 a.m. Eastern Daylight Time.

Use of Non-GAAP Financial Measures

Adjusted EPS, adjusted net income, adjusted operating income, adjusted operating margin, free cash flow, organic revenue growth and Core organic revenue growth are non-GAAP measures that exclude certain items detailed after the tables that accompany this press release, under the heading "Supplemental Information Regarding Non-GAAP Financial Measures." The reconciliations of GAAP to non-GAAP financial measures are provided in the tables that accompany this press release.

Conference Call

Thermo Fisher Scientific will hold its earnings conference call today, July 28, 2022, at 8:30 a.m. Eastern Daylight Time. To listen, dial (844) 200-6205 within the U.S. or (929) 526-1599 outside the U.S. The conference ID is 512129. You may also listen to the call live on our website, www.thermofisher.com , by clicking on "Investors." You will find this press release, including the accompanying reconciliation of non-GAAP financial measures and related information, in that section of our website under "Financials." An audio archive of the call will be available under "News & Events" through Friday, August 12, 2022.

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com .

Safe Harbor Statement

The following constitutes a "Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995: This press release contains forward-looking statements that involve a number of risks and uncertainties. Important factors that could cause actual results to differ materially from those indicated by forward-looking statements include risks and uncertainties relating to: the duration and severity of the COVID-19 pandemic; the need to develop new products and adapt to significant technological change; implementation of strategies for improving growth; general economic conditions and related uncertainties; dependence on customers' capital spending policies and government funding policies; the effect of economic and political conditions and exchange rate fluctuations on international operations; use and protection of intellectual property; the effect of changes in governmental regulations; any natural disaster, public health crisis or other catastrophic event; and the effect of laws and regulations governing government contracts, as well as the possibility that expected benefits related to recent or pending acquisitions may not materialize as expected. Additional important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are set forth in our most recent annual report on Form 10-K and subsequent quarterly report on Form 10-Q, which are on file with the SEC and available in the "Investors" section of our website under the heading "SEC Filings." While we may elect to update forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if estimates change and, therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today.

Condensed Consolidated Statement of Income (unaudited)

Three Months Ended

July 2,

% of

July 3,

% of

(In millions except per share amounts)

2022

Revenues

2021

Revenues

Revenues

$

10,970

$

9,273

Costs and operating expenses:

Cost of revenues (a)

6,240

56.9

%

4,585

49.4

%

Selling, general and administrative expenses (b)

1,740

15.9

%

1,614

17.4

%

Amortization of acquisition-related intangible assets

600

5.5

%

449

4.8

%

Research and development expenses

365

3.3

%

343

3.7

%

Restructuring and other costs (c)

24

0.2

%

119

1.3

%

8,969

81.8

%

7,110

76.7

%

Operating income

2,001

18.2

%

2,163

23.3

%

Interest income

36

11

Interest expense

(148

)

(122

)

Other income/(expense) (d)

28

(3

)

Income before income taxes

1,917

2,049

Provision for income taxes (e)

(198

)

(219

)

Equity in earnings/(losses) of unconsolidated entities

(51

)

(1

)

Net income

1,668

1,829

Less: net income attributable to noncontrolling interests and redeemable noncontrolling interest

4

1

Net income attributable to Thermo Fisher Scientific Inc.

$

1,664

15.2

%

$

1,828

19.7

%

Earnings per share attributable to Thermo Fisher Scientific Inc.:

Basic

$

4.25

$

4.65

Diluted

$

4.22

$

4.61

Weighted average shares:

Basic

392

393

Diluted

394

396

Reconciliation of adjusted operating income and adjusted operating margin

GAAP operating income

$

2,001

18.2

%

$

2,163

23.3

%

Cost of revenues adjustments (a)

8

0.1

%

—

0.0

%

Selling, general and administrative expenses adjustments (b)

(28

)

-0.3

%

(42

)

-0.4

%

Restructuring and other costs (c)

24

0.2

%

119

1.3

%

Amortization of acquisition-related intangible assets

600

5.5

%

449

4.8

%

Adjusted operating income (non-GAAP measure)

$

2,605

23.7

%

$

2,689

29.0

%

Reconciliation of adjusted net income

GAAP net income attributable to Thermo Fisher Scientific Inc.

$

1,664

$

1,828

Cost of revenues adjustments (a)

8

—

Selling, general and administrative expenses adjustments (b)

(28

)

(42

)

Restructuring and other costs (c)

24

119

Amortization of acquisition-related intangible assets

600

449

Other income/expense adjustments (d)

(18

)

8

Provision for income taxes adjustments (e)

(127

)

(142

)

Equity in earnings/losses of unconsolidated entities

51

1

Adjusted net income (non-GAAP measure)

$

2,174

$

2,221

Reconciliation of adjusted earnings per share

GAAP diluted EPS attributable to Thermo Fisher Scientific Inc.

$

4.22

$

4.61

Cost of revenues adjustments (a)

0.02

0.00

Selling, general and administrative expenses adjustments (b)

(0.07

)

(0.10

)

Restructuring and other costs (c)

0.06

0.30

Amortization of acquisition-related intangible assets

1.52

1.13

Other income/expense adjustments (d)

(0.05

)

0.02

Provision for income taxes adjustments (e)

(0.32

)

(0.36

)

Equity in earnings/losses of unconsolidated entities

0.13

0.00

Adjusted EPS (non-GAAP measure)

$

5.51

$

5.60

Reconciliation of free cash flow

GAAP net cash provided by operating activities

$

1,528

$

2,227

Purchases of property, plant and equipment

(506

)

(540

)

Proceeds from sale of property, plant and equipment

12

—

Free cash flow (non-GAAP measure)

$

1,034

$

1,687

Segment data

Three Months Ended

July 2,

% of

July 3,

% of

(In millions)

2022

Revenues

2021

Revenues

Revenues

Life Sciences Solutions

$

3,292

30.0

%

$

3,557

38.4

%

Analytical Instruments

1,607

14.6

%

1,481

16.0

%

Specialty Diagnostics

1,101

10.0

%

1,235

13.3

%

Laboratory Products and Biopharma Services

5,537

50.5

%

3,583

38.6

%

Eliminations

(567

)

-5.1

%

(583

)

-6.3

%

Consolidated revenues

$

10,970

100.0

%

$

9,273

100.0

%

Operating income and operating margin

Life Sciences Solutions

$

1,327

40.3

%

$

1,718

48.3

%

Analytical Instruments

344

21.4

%

280

18.9

%

Specialty Diagnostics

243

22.1

%

245

19.9

%

Laboratory Products and Biopharma Services

691

12.5

%

446

12.4

%

Subtotal reportable segments

2,605

23.7

%

2,689

29.0

%

Cost of revenues adjustments (a)

(8

)

-0.1

%

—

0.0

%

Selling, general and administrative expenses adjustments (b)

28

0.3

%

42

0.4

%

Restructuring and other costs (c)

(24

)

-0.2

%

(119

)

-1.3

%

Amortization of acquisition-related intangible assets

(600

)

-5.5

%

(449

)

-4.8

%

GAAP operating income

$

2,001

18.2

%

$

2,163

23.3

%

(a) Adjusted results in 2022 exclude charges for the sale of inventories revalued at the date of acquisition.

(b) Adjusted results in 2022 and 2021 exclude certain third-party expenses, principally transaction/integration costs related to recent acquisitions and charges/credits for changes in estimates of contingent acquisition consideration.

(c) Adjusted results in 2022 and 2021 exclude restructuring and other costs consisting principally of severance, abandoned facility and other expenses of headcount reductions within several businesses and real estate consolidations. Adjusted results in 2021 also exclude $110 of charges for impairment of technology.

(d) Adjusted results in 2022 and 2021 exclude net gains/losses on investments. Adjusted results in 2021 also exclude amortization of bridge loan commitment fees related to a pending acquisition.

(e) Adjusted provision for income taxes in 2022 and 2021 excludes incremental tax impacts for the reconciling items between GAAP and adjusted net income, and incremental tax impacts as a result of tax rate/law changes. Adjusted results in 2022 also exclude incremental tax impacts from audit settlements.

Note:

Consolidated depreciation expense is $236 and $211 in 2022 and 2021, respectively.

Organic and Core organic revenue growth

Three months ended

July 2, 2022

Revenue growth

18 %

Acquisitions

19 %

Currency translation

-4 %

Organic revenue growth

3 %

COVID-19 testing revenue

-11 %

Contribution of PPD to Core organic revenue growth (a)

-1 %

Core organic revenue growth

13 %

(a) Adjustment to include the contribution of PPD to Core organic revenue growth as though the acquisition had occurred on January 1, 2021.

Note:

For more information related to non-GAAP financial measures, refer to the section titled "Supplemental Information Regarding Non-GAAP Financial Measures" of this release.

Condensed Consolidated Statement of Income (unaudited)

Six months ended

July 2,

% of

July 3,

% of

(In millions except per share amounts)

2022

Revenues

2021

Revenues

Revenues

$

22,788

$

19,179

Costs and operating expenses:

Cost of revenues (a)

12,454

54.7

%

9,142

47.7

%

Selling, general and administrative expenses (b)

3,548

15.6

%

3,157

16.5

%

Amortization of acquisition-related intangible assets

1,209

5.3

%

872

4.5

%

Research and development expenses

729

3.2

%

663

3.5

%

Restructuring and other costs (c)

26

0.1

%

133

0.7

%

17,966

78.8

%

13,967

72.8

%

Operating income

4,822

21.2

%

5,212

27.2

%

Interest income

54

23

Interest expense

(284

)

(247

)

Other income/(expense) (d)

(135

)

(186

)

Income before income taxes

4,457

4,802

Provision for income taxes (e)

(499

)

(635

)

Equity in earnings/(losses) of unconsolidated entities

(70

)

(1

)

Net income

3,888

4,166

Less: net income attributable to noncontrolling interests and redeemable noncontrolling interest

9

1

Net income attributable to Thermo Fisher Scientific Inc.

$

3,879

17.0

%

$

4,165

21.7

%

Earnings per share attributable to Thermo Fisher Scientific Inc.:

Basic

$

9.90

$

10.58

Diluted

$

9.83

$

10.50

Weighted average shares:

Basic

392

394

Diluted

394

397

Reconciliation of adjusted operating income and adjusted operating margin

GAAP operating income

$

4,822

21.2

%

$

5,212

27.2

%

Cost of revenues adjustments (a)

19

0.1

%

8

0.0

%

Selling, general and administrative expenses adjustments (b)

(21

)

-0.1

%

(26

)

-0.1

%

Restructuring and other costs (c)

26

0.1

%

133

0.7

%

Amortization of acquisition-related intangible assets

1,209

5.3

%

872

4.5

%

Adjusted operating income (non-GAAP measure)

$

6,055

26.6

%

$

6,199

32.3

%

Reconciliation of adjusted net income

GAAP net income attributable to Thermo Fisher Scientific Inc.

$

3,879

$

4,165

Cost of revenues adjustments (a)

19

8

Selling, general and administrative expenses adjustments (b)

(21

)

(26

)

Restructuring and other costs (c)

26

133

Amortization of acquisition-related intangible assets

1,209

872

Other income/expense adjustments (d)

149

205

Provision for income taxes adjustments (e)

(296

)

(272

)

Equity in earnings/losses of unconsolidated entities

70

1

Adjusted net income (non-GAAP measure)

$

5,035

$

5,086

Reconciliation of adjusted earnings per share

GAAP diluted EPS attributable to Thermo Fisher Scientific Inc.

$

9.83

$

10.50

Cost of revenues adjustments (a)

0.05

0.02

Selling, general and administrative expenses adjustments (b)

(0.05

)

(0.07

)

Restructuring and other costs (c)

0.06

0.34

Amortization of acquisition-related intangible assets

3.06

2.20

Other income/expense adjustments (d)

0.38

0.51

Provision for income taxes adjustments (e)

(0.75

)

(0.69

)

Equity in earnings/losses of unconsolidated entities

0.18

0.00

Adjusted EPS (non-GAAP measure)

$

12.76

$

12.81

Reconciliation of free cash flow

GAAP net cash provided by operating activities

$

3,730

$

4,205

Purchases of property, plant and equipment

(1,146

)

(1,168

)

Proceeds from sale of property, plant and equipment

14

5

Free cash flow (non-GAAP measure)

$

2,598

$

3,042

Segment data

Six months ended

July 2,

% of

July 3,

% of

(In millions)

2022

Revenues

2021

Revenues

Revenues

Life Sciences Solutions

$

7,523

33.0

%

$

7,760

40.5

%

Analytical Instruments

3,125

13.7

%

2,868

15.0

%

Specialty Diagnostics

2,583

11.3

%

2,850

14.9

%

Laboratory Products and Biopharma Services

10,979

48.2

%

7,180

37.4

%

Eliminations

(1,422

)

-6.2

%

(1,479

)

-7.8

%

Consolidated revenues

$

22,788

100.0

%

$

19,179

100.0

%

Operating income and operating margin

Life Sciences Solutions

$

3,503

46.6

%

$

3,997

51.5

%

Analytical Instruments

645

20.6

%

552

19.3

%

Specialty Diagnostics

596

23.1

%

673

23.6

%

Laboratory Products and Biopharma Services

1,311

11.9

%

977

13.6

%

Subtotal reportable segments

6,055

26.6

%

6,199

32.3

%

Cost of revenues adjustments (a)

(19

)

-0.1

%

(8

)

0.0

%

Selling, general and administrative expenses adjustments (b)

21

0.1

%

26

0.1

%

Restructuring and other costs (c)

(26

)

-0.1

%

(133

)

-0.7

%

Amortization of acquisition-related intangible assets

(1,209

)

-5.3

%

(872

)

-4.5

%

GAAP operating income

$

4,822

21.2

%

$

5,212

27.2

%

(a) Adjusted results in 2022 and 2021 exclude charges for the sale of inventories revalued at the date of acquisition.

(b) Adjusted results in 2022 and 2021 exclude certain third-party expenses, principally transaction/integration costs related to recent acquisitions and charges/credits for changes in estimates of contingent acquisition consideration.

(c) Adjusted results in 2022 and 2021 exclude restructuring and other costs consisting principally of severance, abandoned facility and other expenses of headcount reductions within several businesses and real estate consolidations. Adjusted results in 2021 also exclude $110 of charges for impairment of acquired technology and $13 of charges for compensation due to employees at recently acquired businesses at the date of acquisition.

(d) Adjusted results in 2022 and 2021 exclude net gains/losses on investments and losses on the early extinguishment of debt. Adjusted results in 2021 also exclude amortization of bridge loan commitment fees related to a pending acquisition.

(e) Adjusted provision for income taxes in 2022 and 2021 excludes incremental tax impacts for the reconciling items between GAAP and adjusted net income, and incremental tax impacts as a result of tax rate/law changes. Adjusted results in 2022 also exclude incremental tax impacts from audit settlements.

Notes:

Consolidated depreciation expense is $486 and $409 in 2022 and 2021, respectively.

For more information related to non-GAAP financial measures, refer to the section titled "Supplemental Information Regarding Non-GAAP Financial Measures" of this release.

Condensed Consolidated Balance Sheet (unaudited)

July 2,

December 31,

(In millions)

2022

2021

Assets

Current assets:

Cash and cash equivalents

$

1,888

$

4,477

Accounts receivable, net

7,745

7,977

Inventories

5,668

5,051

Other current assets

2,799

2,608

Total current assets

18,100

20,113

Property, plant and equipment, net

8,529

8,333

Acquisition-related intangible assets, net

18,578

20,113

Other assets

4,306

4,640

Goodwill

41,066

41,924

Total assets

$

90,579

$

95,123

Liabilities, redeemable noncontrolling interest and equity

Current liabilities:

Short-term obligations and current maturities of long-term obligations

$

1,010

$

2,537

Other current liabilities

9,987

10,899

Total current liabilities

10,997

13,436

Other long-term liabilities

7,861

8,377

Long-term obligations

29,250

32,333

Redeemable noncontrolling interest

117

122

Total equity

42,354

40,855

Total liabilities, redeemable noncontrolling interest and equity

$

90,579

$

95,123

Condensed Consolidated Statement of Cash Flows (unaudited)

Six months ended

July 2,

July 3,

(In millions)

2022

2021

Operating activities

Net income

$

3,888

$

4,166

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

Depreciation and amortization

1,695

1,281

Change in deferred income taxes

(601

)

(307

)

Other non-cash expenses, net

472

512

Changes in assets and liabilities, excluding the effects of acquisitions

(1,724

)

(1,447

)

Net cash provided by operating activities

3,730

4,205

Investing activities

Acquisitions, net of cash acquired

(40

)

(1,425

)

Purchases of property, plant and equipment

(1,146

)

(1,168

)

Proceeds from sale of property, plant and equipment

14

5

Other investing activities, net

83

(36

)

Net cash used in investing activities

(1,089

)

(2,624

)

Financing activities

Repayment of debt

(375

)

(2,803

)

Net proceeds from issuance of commercial paper

1,032

—

Repayment of commercial paper

(3,490

)

—

Purchases of company common stock

(2,000

)

(2,000

)

Dividends paid

(220

)

(190

)

Net proceeds from issuance of company common stock under employee stock plans

51

72

Other financing activities, net

(48

)

(5

)

Net cash used in financing activities

(5,050

)

(4,926

)

Exchange rate effect on cash

(177

)

44

Decrease in cash, cash equivalents and restricted cash

(2,586

)

(3,301

)

Cash, cash equivalents and restricted cash at beginning of period

4,491

10,336

Cash, cash equivalents and restricted cash at end of period

$

1,905

$

7,035

Free cash flow (non-GAAP measure)

$

2,598

$

3,042

Note:

For more information related to non-GAAP financial measures, refer to the section titled "Supplemental Information Regarding Non-GAAP Financial Measures" of this release.

Supplemental Information Regarding Non-GAAP Financial Measures

In addition to the financial measures prepared in accordance with generally accepted accounting principles (GAAP), we use certain non-GAAP financial measures such as organic revenue growth, which is reported revenue growth, excluding the impacts of revenues from acquired businesses and the effects of currency translation. We also report Core organic revenue growth, which is reported revenue growth including the impact of PPD revenue, excluding the impacts of COVID-19 testing revenue, and excluding the impacts of acquisitions other than PPD and currency translation. We calculate period-to-period Core organic revenue growth by adding to the baseline period PPD's pre-acquisition revenues from such period. We report these measures because Thermo Fisher management believes that in order to understand the company's short-term and long-term financial trends, investors may wish to consider the impact of acquisitions, foreign currency translation and/or COVID-19 testing on revenues. In particular, given PPD's significance relative to our existing businesses, management believes it is appropriate to also present information on a basis that includes PPD pre-acquisition revenues in order to demonstrate the impact PPD has on our current growth profile. Core organic revenue growth amounts are not necessarily indicative of the combined results of operations that would have been realized had the PPD acquisition occurred on January 1, 2021. Thermo Fisher management uses these measures to forecast and evaluate the operational performance of the company as well as to compare revenues of current periods to prior periods.

We report adjusted operating income, adjusted operating income margin, adjusted net income, and adjusted EPS. We believe that the use of these non-GAAP financial measures, in addition to GAAP financial measures, helps investors to gain a better understanding of our core operating results and future prospects, consistent with how management measures and forecasts the company's core operating performance, especially when comparing such results to previous periods, forecasts, and to the performance of our competitors. Such measures are also used by management in their financial and operating decision-making and for compensation purposes. To calculate these measures we exclude, as applicable:

  • Certain acquisition-related costs, including charges for the sale of inventories revalued at the date of acquisition, significant transaction/acquisition-related costs, including changes in estimates of contingent acquisition-related consideration, and other costs associated with obtaining short-term financing commitments for pending/recent acquisitions. We exclude these costs because we do not believe they are indicative of our normal operating costs.
  • Costs/income associated with restructuring activities, such as reducing overhead and consolidating facilities. We exclude these costs because we believe that the costs related to restructuring activities are not indicative of our normal operating costs.
  • Equity in earnings/losses of unconsolidated entities; impairments of long-lived assets; and certain other gains and losses that are either isolated or cannot be expected to occur again with any predictability, including gains/losses on investments, the sale of businesses, product lines, and real estate, significant litigation-related matters, curtailments/settlements of pension plans, and the early retirement of debt. We exclude these items because they are outside of our normal operations and/or, in certain cases, are difficult to forecast accurately for future periods.
  • The expense associated with the amortization of acquisition-related intangible assets because a significant portion of the purchase price for acquisitions may be allocated to intangible assets that have lives of up to 20 years. Exclusion of the amortization expense allows comparisons of operating results that are consistent over time for both our newly acquired and long-held businesses and with both acquisitive and non-acquisitive peer companies.
  • The tax impacts of the above items and the impact of significant tax audits or events (such as changes in deferred taxes from enacted tax rate/law changes), the latter of which we exclude because they are outside of our normal operations and difficult to forecast accurately for future periods.

We report free cash flow, which is operating cash flow excluding net capital expenditures, to provide a view of the continuing operations' ability to generate cash for use in acquisitions and other investing and financing activities. The company also uses this measure as an indication of the strength of the company. Free cash flow is not a measure of cash available for discretionary expenditures since we have certain non-discretionary obligations such as debt service that are not deducted from the measure.

Thermo Fisher Scientific does not provide GAAP financial measures on a forward-looking basis because we are unable to predict with reasonable certainty and without unreasonable effort items such as the timing and amount of future restructuring actions and acquisition-related charges as well as gains or losses from sales of real estate and businesses, the early retirement of debt and the outcome of legal proceedings. The timing and amount of these items are uncertain and could be material to Thermo Fisher Scientific's results computed in accordance with GAAP.

The non-GAAP financial measures of Thermo Fisher Scientific's results of operations and cash flows included in this press release are not meant to be considered superior to or a substitute for Thermo Fisher Scientific's results of operations prepared in accordance with GAAP. Reconciliations of such non-GAAP financial measures to the most directly comparable GAAP financial measures are set forth in the tables above.

Media Contact Information:
Ron O'Brien
Phone: 781-622-1242
E-mail: ron.obrien@thermofisher.com

Investor Contact Information:
Rafael Tejada
Phone: 781-622-1356
E-mail: rafael.tejada@thermofisher.com

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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 financial results for the first quarter ended March 31, 2025, and provided a business update highlighting continued regulatory momentum, disciplined operational execution, and a strengthening clinical development pipeline.

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

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  • 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

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SOURCE Medtronic plc

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