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Orthofix Reports Third Quarter 2022 Results

  • Net sales of $114.0 million, an increase of 1% on a reported basis and 5% on a constant currency basis over prior year
  • Global Orthopedics net sales growth of 19% on a constant currency basis driven by new product and channel investments
  • GAAP EPS of ($0.53) and adjusted EPS of $0.13
  • Orthofix and MTF Biologics recognized with the 2022 Spine Technology Award from Orthopedics This Week for Virtuos Lyograft, the first of its kind, shelf-stable and complete autograft substitute
  • Announced agreement to merge with SeaSpine, creating a leading global spine and orthopedics company

Orthofix Medical Inc. (NASDAQ:OFIX) today reported its financial results for the quarter ended September 30, 2022. Net sales were $114.0 million, earnings per share (“EPS”) was $(0.53), and adjusted EPS was $0.13.

“New product innovation and commercial channel execution delivered a strong performance during the third quarter,” said Orthofix President and Chief Executive Officer Jon Serbousek. “Global Orthopedics, Biologics, and Bone Growth Therapies drove topline growth as solid portfolio-wide sales were bolstered by exciting market adoption trends from a number of recently launched products such as AccelStim™ Bone Healing Therapy and Virtuos™ Lyograft.”

Continued Serbousek. “We are bullish about the future of Orthofix, even more so following the recent agreement to merge with SeaSpine. The combination of these two businesses will form an extremely well-positioned spine and orthopedics company with a unique profile of scale, growth, and profitability. It will be supported by a strong balance sheet capable of self-funding initiatives to deliver innovative solutions to improve patient outcomes on a global scale.”

Financial Results Overview

The following table provides net sales by major product category by reporting segment:

 

 

Three Months Ended September 30,

 

(Unaudited, U.S. Dollars, in thousands)

 

2022

 

 

2021

 

 

Change

 

 

Constant

Currency

Change

 

Bone Growth Therapies

 

$

46,531

 

 

$

45,168

 

 

 

3.0

%

 

 

3.0

%

Spinal Implants

 

 

25,857

 

 

 

28,151

 

 

 

(8.1

%)

 

 

(7.1

%)

Biologics

 

 

13,798

 

 

 

12,806

 

 

 

7.7

%

 

 

7.7

%

Global Spine

 

 

86,186

 

 

 

86,125

 

 

 

0.1

%

 

 

0.4

%

Global Orthopedics

 

 

27,810

 

 

 

26,303

 

 

 

5.7

%

 

 

19.0

%

Net sales

 

$

113,996

 

 

$

112,428

 

 

 

1.4

%

 

 

4.8

%

Gross profit decreased $0.7 million to $83.4 million. Gross margin decreased to 73.2% compared to 74.8% in the prior year period.

Net loss was $(10.7) million, or $(0.53) per share, compared to net loss of $(2.2) million, or $(0.11) per share in the prior year period. Adjusted net income was $2.7 million, or $0.13 per share, compared to adjusted net income of $2.0 million, or $0.10 per share in the prior year period.

EBITDA was $(1.5) million, compared to $5.0 million in the prior year period. Adjusted EBITDA was $14.3 million, or 12.5% of net sales, compared to $11.9 million, or 10.6% of net sales, in the prior year period.

Liquidity

As of September 30, 2022, cash totaled $51.7 million, compared to $87.8 million as of December 31, 2021. As of September 30, 2022, the Company had no borrowings under its five year $300 million secured revolving credit facility. For the first nine months of 2022, cash flow from operations decreased $20.6 million to $(13.9) million, while free cash flow decreased $25.1 million to $(31.1) million.

Business Outlook

As of the date hereof, the Company expects the following net sales results for the year ended December 31, 2022. These expectations are based on the current foreign currency exchange rates and do not include any additional exchange rate changes that may occur this year.

 

 

Current 2022 Outlook

 

Previous 2022 Outlook

(Unaudited, U.S. Dollars, in millions, except per share data)

 

Range

 

Range

Full year net sales

 

$457 - $463

 

$455 - $465

Full year net sales growth rates – reported

 

(2%) - 0%

 

(2%) - 0%

Full year net sales growth rates – constant currency

 

1% - 2%

 

0% - 2%

 

 

 

 

 

Full year adjusted EBITDA

 

$52 - $54

 

$53 - $57

Full year adjusted EBITDA as percentage of net sales 1

 

12%

 

12%

 

 

 

 

 

Full year adjusted EPS

 

$0.40-$0.50

 

$0.45-$0.55

 

1 Calculated using the midpoint of estimated full year net sales

The Company is not able to provide expectations of GAAP operating income or GAAP EPS, the closest comparable U.S. GAAP measures to Adjusted EBITDA and Adjusted EPS, respectively (each of which are non-GAAP measures), on a forward-looking basis because the Company is unable to predict without unreasonable efforts the ultimate outcome of matters (including legal proceedings, acquisition-related expenses, accounting fair value adjustments, and other such items) that will determine the quantitative amount of the items excluded from the applicable non-GAAP measure, which items are further described in the reconciliation tables and related descriptions below. These items are uncertain, depend on various factors, and could be material to the Company’s results computed in accordance with U.S. GAAP.

Conference Call

Orthofix will host a conference call today at 8:30 AM Eastern time to discuss the Company's financial results for the third quarter of 2022. Interested parties may access the conference call by dialing (888) 330-2508 in the U.S. and Canada, and (240) 789-2735 in all other locations, and referencing the access code 9556380. A replay of the call will be available for three weeks by dialing (800) 770-2030 in the U.S. and Canada, and (647) 362-9199 in all other locations, and entering the access code 9556380. A webcast of the conference call may be accessed at ir.Orthofix.com.

Orthofix and SeaSpine to Combine in Merger of Equals

In a press release on, October 11, 2022, it was announced that the Company and SeaSpine have entered into a definitive agreement to combine in an all-stock merger of equals. For more details, please visit ir.Orthofix.com/events-and-presentations.

About Orthofix

Orthofix Medical Inc. is a global medical device company with a spine and orthopedics focus. The Company’s mission is to deliver innovative, quality-driven solutions while partnering with health care professionals to improve patient mobility. Headquartered in Lewisville, Texas, Orthofix’s spine and orthopedics products are distributed in more than 60 countries via the Company's sales representatives and distributors. For more information, please visit www.orthofix.com.

Forward-Looking Statements

This communication contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, relating to our business and financial outlook, which are based on our current beliefs, assumptions, expectations, estimates, forecasts and projections. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “intends,” “predicts,” “potential,” or “continue” or other comparable terminology. These forward-looking statements are not guarantees of our future performance and involve risks, uncertainties, estimates and assumptions that are difficult to predict, including the risks described in Part I, Item 1A under the heading Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2021 (the “2021 Form 10-K”), and in Part II, Item 1A under the heading Risk Factors in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2022. Factors that could cause or contribute to such differences may include, but are not limited to, (i) risks relating to the effects of the COVID-19 pandemic on our business, (ii) our ability to maintain operations to support our customers and patients in the near-term and to capitalize on future growth opportunities, (iii) risks associated with acceptance of surgical products and procedures by surgeons and hospitals, (iv) development and acceptance of new products or product enhancements, (v) clinical and statistical verification of the benefits achieved via the use of our products, (vi) our ability to adequately manage inventory, (vii) our ability to recruit and retain management and key personnel, (viii) global economic instability and potential supply chain disruption caused by Russia’s unlawful invasion of Ukraine and resulting sanctions, and (ix) the other risks and uncertainties more fully described in our periodic filings with the Securities and Exchange Commission (the “SEC”). To the extent that the COVID-19 pandemic continues to adversely affect our business and financial results, it may also have the effect of heightening many of the other risks described in Part I, Item 1A under the heading Risk Factors in our 2021 Form 10-K, such as our ability to generate sufficient cash flows to run our business and our ability to protect our information technology networks and infrastructure from unauthorized access, misuse, malware, phishing and other events that could have a security impact as a result of our remote working environment or otherwise. As a result of these various risks, our actual outcomes and results may differ materially from those expressed in these forward-looking statements.

This list of risks, uncertainties, and other factors is not complete. We discuss some of these matters more fully, as well as certain risk factors that could affect our business, financial condition, results of operations, and prospects, in reports we file from time-to-time with the SEC, which are available to read at www.sec.gov. Any or all forward-looking statements that we make may turn out to be wrong (due to inaccurate assumptions that we make or otherwise), and our actual outcomes and results may differ materially from those expressed in these forward-looking statements. You should not place undue reliance on any of these forward-looking statements. Further, any forward-looking statement speaks only as of the date hereof, unless it is specifically otherwise stated to be made as of a different date. We undertake no obligation to update, and expressly disclaim any duty to update, our forward-looking statements, whether as a result of circumstances or events that arise after the date hereof, new information, or otherwise.

ORTHOFIX MEDICAL INC.

Condensed Consolidated Statements of Operations

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

(U.S. Dollars, in thousands, except share and per share data)

 

2022

 

 

2021

 

 

2022

 

 

2021

 

 

 

(Unaudited)

 

 

(Unaudited)

 

Net sales

 

$

113,996

 

 

$

112,428

 

 

$

338,484

 

 

$

339,415

 

Cost of sales

 

 

30,573

 

 

 

28,307

 

 

 

90,491

 

 

 

81,660

 

Gross profit

 

 

83,423

 

 

 

84,121

 

 

 

247,993

 

 

 

257,755

 

Sales and marketing

 

 

55,461

 

 

 

56,097

 

 

 

169,486

 

 

 

164,220

 

General and administrative

 

 

19,322

 

 

 

16,312

 

 

 

54,496

 

 

 

51,091

 

Research and development

 

 

11,943

 

 

 

12,360

 

 

 

35,913

 

 

 

36,378

 

Acquisition-related amortization and remeasurement

 

 

2,484

 

 

 

(335

)

 

 

(9,678

)

 

 

5,028

 

Operating income (loss)

 

 

(5,787

)

 

 

(313

)

 

 

(2,224

)

 

 

1,038

 

Interest expense, net

 

 

(277

)

 

 

(433

)

 

 

(1,059

)

 

 

(1,400

)

Other expense, net

 

 

(3,308

)

 

 

(1,789

)

 

 

(7,436

)

 

 

(3,528

)

Loss before income taxes

 

 

(9,372

)

 

 

(2,535

)

 

 

(10,719

)

 

 

(3,890

)

Income tax benefit (expense)

 

 

(1,344

)

 

 

364

 

 

 

(1,968

)

 

 

(1,677

)

Net loss

 

$

(10,716

)

 

$

(2,171

)

 

$

(12,687

)

 

$

(5,567

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per common share:

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

(0.53

)

 

$

(0.11

)

 

$

(0.63

)

 

$

(0.28

)

Diluted

 

 

(0.53

)

 

 

(0.11

)

 

 

(0.63

)

 

 

(0.28

)

Weighted average number of common shares (in millions):

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

20.1

 

 

 

19.8

 

 

 

20.0

 

 

 

19.6

 

Diluted

 

 

20.1

 

 

 

19.8

 

 

 

20.0

 

 

 

19.6

 

ORTHOFIX MEDICAL INC.

Condensed Consolidated Balance Sheets

 

(U.S. Dollars, in thousands, except par value data)

 

September 30,

2022

 

 

December 31,

2021

 

 

 

(Unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

Cash and cash equivalents

 

$

51,660

 

 

$

87,847

 

Accounts receivable, net of allowances of $5,948 and $4,944, respectively

 

 

75,633

 

 

 

78,560

 

Inventories

 

 

100,277

 

 

 

82,974

 

Prepaid expenses and other current assets

 

 

19,325

 

 

 

20,141

 

Total current assets

 

 

246,895

 

 

 

269,522

 

Property, plant, and equipment, net

 

 

57,820

 

 

 

59,252

 

Intangible assets, net

 

 

47,513

 

 

 

52,666

 

Goodwill

 

 

71,317

 

 

 

71,317

 

Deferred income taxes

 

 

1,544

 

 

 

1,771

 

Other long-term assets

 

 

24,571

 

 

 

22,095

 

Total assets

 

$

449,660

 

 

$

476,623

 

Liabilities and shareholders’ equity

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

Accounts payable

 

$

28,003

 

 

$

26,459

 

Current portion of finance lease liability

 

 

638

 

 

 

2,590

 

Other current liabilities

 

 

49,007

 

 

 

76,781

 

Total current liabilities

 

 

77,648

 

 

 

105,830

 

Long-term portion of finance lease liability

 

 

19,407

 

 

 

19,890

 

Other long-term liabilities

 

 

19,066

 

 

 

13,969

 

Total liabilities

 

 

116,121

 

 

 

139,689

 

Contingencies

 

 

 

 

 

 

Shareholders’ equity

 

 

 

 

 

 

Common shares $0.10 par value; 50,000 shares authorized;

20,007 and 19,837 issued and outstanding as of September 30,

2022 and December 31, 2021, respectively

 

 

2,001

 

 

 

1,983

 

Additional paid-in capital

 

 

328,387

 

 

 

313,951

 

Retained earnings

 

 

8,313

 

 

 

21,000

 

Accumulated other comprehensive loss

 

 

(5,162

)

 

 

 

Total shareholders’ equity

 

 

333,539

 

 

 

336,934

 

Total liabilities and shareholders’ equity

 

$

449,660

 

 

$

476,623

 

ORTHOFIX MEDICAL INC.

Non-GAAP Financial Measures

The following tables present reconciliations of operating income (loss), net income (loss), EPS, and net cash from operating activities, in each case calculated in accordance with U.S. generally accepted accounting principles (“GAAP”), to, as applicable, non-GAAP financial measures, referred to as "EBITDA," "Adjusted EBITDA," "Adjusted net income (loss)," "Adjusted EPS," and "Free cash flow" that exclude items specified in the tables. The GAAP measures shown in the tables below represent the most comparable GAAP measure to the applicable non-GAAP measure(s) shown in the table. A more detailed explanation of the items excluded from these non-GAAP financial measures, as well as why management believes the non-GAAP financial measures are useful to them, is included following the reconciliations. The non-GAAP adjusted results shown below and within this press release, which exclude the items specified in the reconciliation tables below, should not be construed as a substitute for, or a better indicator of, the Company’s performance than the Company’s GAAP results.

EBITDA and Adjusted EBITDA

 

 

Three Months Ended September 30, 2022

 

(Unaudited, U.S. Dollars, in thousands)

 

Total Orthofix

 

 

Global Spine

 

 

Global Orthopedics

 

 

Corporate

 

Operating income (loss)

 

$

(5,787

)

 

$

5,960

 

 

$

(183

)

 

$

(11,564

)

Other income (expense), net

 

 

(3,308

)

 

 

(881

)

 

 

(1,868

)

 

 

(559

)

Depreciation and amortization

 

 

5,499

 

 

 

3,120

 

 

 

1,424

 

 

 

955

 

Amortization of acquired intangibles

 

 

2,071

 

 

 

1,917

 

 

 

154

 

 

 

 

EBITDA

 

$

(1,525

)

 

$

10,116

 

 

$

(473

)

 

$

(11,168

)

Share-based compensation

 

 

4,720

 

 

 

1,927

 

 

 

476

 

 

 

2,317

 

Foreign exchange impact

 

 

3,253

 

 

 

875

 

 

 

1,816

 

 

 

562

 

Strategic investments

 

 

3,392

 

 

 

51

 

 

 

158

 

 

 

3,183

 

Acquisition-related fair value adjustments

 

 

419

 

 

 

419

 

 

 

 

 

 

 

Loss on investment securities

 

 

(1

)

 

 

 

 

 

 

 

 

(1

)

Legal judgments/settlements

 

 

125

 

 

 

125

 

 

 

 

 

 

 

Succession and transition charges

 

 

68

 

 

 

(44

)

 

 

(7

)

 

 

119

 

Medical device regulation

 

 

2,590

 

 

 

1,917

 

 

 

678

 

 

 

(5

)

Business interruption - COVID-19

 

 

1,216

 

 

 

1,215

 

 

 

 

 

 

1

 

Adjusted EBITDA

 

$

14,257

 

 

$

16,601

 

 

$

2,648

 

 

$

(4,992

)

As a % of net sales

 

 

12.5

%

 

 

14.6

%

 

 

2.3

%

 

 

-4.4

%

 

 

Nine Months Ended September 30, 2022

 

(Unaudited, U.S. Dollars, in thousands)

 

Total Orthofix

 

 

Global Spine

 

 

Global Orthopedics

 

 

Corporate

 

Operating income (loss)

 

$

(2,224

)

 

$

34,878

 

 

$

(6,745

)

 

$

(30,357

)

Other income (expense), net

 

 

(7,436

)

 

 

(1,616

)

 

 

(4,345

)

 

 

(1,475

)

Depreciation and amortization

 

 

15,251

 

 

 

7,879

 

 

 

4,386

 

 

 

2,986

 

Amortization of acquired intangibles

 

 

6,347

 

 

 

5,634

 

 

 

713

 

 

 

 

EBITDA

 

$

11,938

 

 

$

46,775

 

 

$

(5,991

)

 

$

(28,846

)

Share-based compensation

 

 

13,417

 

 

 

5,338

 

 

 

1,329

 

 

 

6,750

 

Foreign exchange impact

 

 

7,486

 

 

 

1,912

 

 

 

4,328

 

 

 

1,246

 

Strategic investments

 

 

6,186

 

 

 

153

 

 

 

573

 

 

 

5,460

 

Acquisition-related fair value adjustments

 

 

(15,795

)

 

 

(15,795

)

 

 

 

 

 

 

Loss on investment securities

 

 

187

 

 

 

 

 

 

 

 

 

187

 

Legal judgments/settlements

 

 

466

 

 

 

241

 

 

 

223

 

 

 

2

 

Succession and transition charges

 

 

146

 

 

 

10

 

 

 

 

 

 

136

 

Medical device regulation

 

 

6,883

 

 

 

4,754

 

 

 

2,144

 

 

 

(15

)

Business interruption - COVID-19

 

 

1,875

 

 

 

1,856

 

 

 

18

 

 

 

1

 

Adjusted EBITDA

 

$

32,789

 

 

$

45,244

 

 

$

2,624

 

 

$

(15,079

)

As a % of net sales

 

 

9.7

%

 

 

13.4

%

 

 

0.8

%

 

 

-4.5

%

 

 

Three Months Ended September 30, 2021

 

(Unaudited, U.S. Dollars, in thousands)

 

Total Orthofix

 

 

Global Spine

 

 

Global Orthopedics

 

 

Corporate

 

Operating income (loss)

 

$

(313

)

 

$

10,042

 

 

$

(976

)

 

$

(9,379

)

Other income (expense), net

 

 

(1,789

)

 

 

(420

)

 

 

(1,231

)

 

 

(138

)

Depreciation and amortization

 

 

4,926

 

 

 

2,501

 

 

 

1,571

 

 

 

854

 

Amortization of acquired intangibles

 

 

2,225

 

 

 

1,785

 

 

 

440

 

 

 

 

EBITDA

 

$

5,049

 

 

$

13,908

 

 

$

(196

)

 

$

(8,663

)

Share-based compensation expense

 

 

3,839

 

 

 

1,590

 

 

 

490

 

 

 

1,759

 

Foreign exchange impact

 

 

1,573

 

 

 

426

 

 

 

1,013

 

 

 

134

 

Strategic investments

 

 

1,322

 

 

 

242

 

 

 

319

 

 

 

761

 

Acquisition-related fair value adjustments

 

 

(2,300

)

 

 

(2,300

)

 

 

 

 

 

 

Legal judgments/settlements

 

 

(321

)

 

 

443

 

 

 

(765

)

 

 

1

 

Succession and transition charges

 

 

21

 

 

 

30

 

 

 

 

 

 

(9

)

Medical device regulation

 

 

2,112

 

 

 

640

 

 

 

501

 

 

 

971

 

Business interruption - COVID-19

 

 

585

 

 

 

567

 

 

 

10

 

 

 

8

 

Adjusted EBITDA

 

$

11,880

 

 

$

15,546

 

 

$

1,372

 

 

$

(5,038

)

As a % of net sales

 

 

10.6

%

 

 

13.8

%

 

 

1.2

%

 

 

-4.5

%

 

 

Nine Months Ended September 30, 2021

 

(Unaudited, U.S. Dollars, in thousands)

 

Total Orthofix

 

 

Global Spine

 

 

Global Orthopedics

 

 

Corporate

 

Operating income (loss)

 

$

1,038

 

 

$

32,366

 

 

$

(4,875

)

 

$

(26,453

)

Other income (expense), net

 

 

(3,528

)

 

 

(638

)

 

 

(2,024

)

 

 

(866

)

Depreciation and amortization

 

 

15,457

 

 

 

7,754

 

 

 

4,906

 

 

 

2,797

 

Amortization of acquired intangibles

 

 

6,696

 

 

 

5,353

 

 

 

1,343

 

 

 

 

EBITDA

 

$

19,663

 

 

$

44,835

 

 

$

(650

)

 

$

(24,522

)

Share-based compensation expense

 

 

11,460

 

 

 

4,716

 

 

 

1,622

 

 

 

5,122

 

Foreign exchange impact

 

 

3,174

 

 

 

672

 

 

 

1,639

 

 

 

863

 

Strategic investments

 

 

3,883

 

 

 

394

 

 

 

2,053

 

 

 

1,436

 

Acquisition-related fair value adjustments

 

 

(825

)

 

 

(450

)

 

 

 

 

 

(375

)

Legal judgments/settlements

 

 

(319

)

 

 

393

 

 

 

(660

)

 

 

(52

)

Succession and transition charges

 

 

664

 

 

 

452

 

 

 

62

 

 

 

150

 

Medical device regulation

 

 

5,923

 

 

 

1,745

 

 

 

1,567

 

 

 

2,611

 

Business interruption - COVID-19

 

 

632

 

 

 

573

 

 

 

26

 

 

 

33

 

Adjusted EBITDA

 

$

44,255

 

 

$

53,330

 

 

$

5,659

 

 

$

(14,734

)

As a % of net sales

 

 

13.0

%

 

 

15.7

%

 

 

1.7

%

 

 

-4.3

%

Adjusted Net Income

 

 

Three Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

(Unaudited, U.S. Dollars, in thousands)

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Net loss

 

$

(10,716

)

 

$

(2,171

)

 

$

(12,687

)

 

$

(5,567

)

Foreign exchange impact

 

 

3,253

 

 

 

1,573

 

 

 

7,486

 

 

 

3,174

 

Strategic investments

 

 

3,383

 

 

 

1,343

 

 

 

6,165

 

 

 

3,976

 

Acquisition-related fair value adjustments

 

 

419

 

 

 

(2,300

)

 

 

(15,795

)

 

 

(825

)

Amortization of acquired intangibles

 

 

2,070

 

 

 

2,232

 

 

 

6,352

 

 

 

6,713

 

Loss on investment securities

 

 

 

 

 

 

 

 

188

 

 

 

 

Legal judgments/settlements

 

 

125

 

 

 

(321

)

 

 

466

 

 

 

(319

)

Succession and transition charges

 

 

68

 

 

 

21

 

 

 

146

 

 

 

664

 

Medical device regulation

 

 

2,594

 

 

 

2,112

 

 

 

6,890

 

 

 

5,923

 

Business interruption - COVID-19

 

 

1,218

 

 

 

587

 

 

 

1,881

 

 

 

638

 

Long-term income tax rate adjustment

 

 

292

 

 

 

(1,096

)

 

 

1,111

 

 

 

(2,658

)

Adjusted net income

 

$

2,706

 

 

$

1,980

 

 

$

2,203

 

 

$

11,719

 

Adjusted EPS

 

 

Three Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

(Unaudited, per diluted share)

 

2022

 

 

2021

 

 

2022

 

 

2021

 

EPS

 

$

(0.53

)

 

$

(0.11

)

 

$

(0.63

)

 

$

(0.28

)

Foreign exchange impact

 

 

0.16

 

 

 

0.08

 

 

 

0.37

 

 

 

0.16

 

Strategic investments

 

 

0.17

 

 

 

0.07

 

 

 

0.31

 

 

 

0.20

 

Acquisition-related fair value adjustments

 

 

0.02

 

 

 

(0.12

)

 

 

(0.79

)

 

 

(0.04

)

Amortization of acquired intangibles

 

 

0.10

 

 

 

0.11

 

 

 

0.32

 

 

 

0.34

 

Loss on investment securities

 

 

 

 

 

 

 

 

0.01

 

 

 

 

Legal judgments/settlements

 

 

0.01

 

 

 

(0.02

)

 

 

0.02

 

 

 

(0.02

)

Succession and transition charges

 

 

 

 

 

 

 

 

0.01

 

 

 

0.03

 

Medical device regulation

 

 

0.13

 

 

 

0.11

 

 

 

0.34

 

 

 

0.30

 

Business interruption - COVID-19

 

 

0.06

 

 

 

0.03

 

 

 

0.09

 

 

 

0.03

 

Long-term income tax rate adjustment

 

 

0.01

 

 

 

(0.05

)

 

 

0.06

 

 

 

(0.13

)

Adjusted EPS

 

$

0.13

 

 

$

0.10

 

 

$

0.11

 

 

$

0.59

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average number of diluted common shares (treasury stock method, in millions)

 

 

20.1

 

 

 

20.0

 

 

 

20.1

 

 

 

19.9

 

Cash Flow and Free Cash Flow

 

 

Nine Months Ended September 30,

 

(Unaudited, U.S. Dollars, in thousands)

 

2022

 

 

2021

 

Net cash from operating activities

 

$

(13,886

)

 

$

6,696

 

Net cash from investing activities

 

 

(18,634

)

 

 

(14,031

)

Net cash from financing activities

 

 

(1,576

)

 

 

(5,673

)

Effect of exchange rate changes on cash

 

 

(2,091

)

 

 

(598

)

Net change in cash and cash equivalents

 

$

(36,187

)

 

$

(13,606

)

 

 

Nine Months Ended September 30,

 

(Unaudited, U.S. Dollars, in thousands)

 

2022

 

 

2021

 

Net cash from operating activities

 

$

(13,886

)

 

$

6,696

 

Capital expenditures

 

 

(17,260

)

 

 

(12,781

)

Free cash flow

 

$

(31,146

)

 

$

(6,085

)

Constant Currency

Constant currency is a non-GAAP measure, which we calculate by using foreign currency rates from the comparable, prior-year period, to present net sales at comparable rates. Constant currency can be presented for numerous GAAP measures, but is most commonly used by management to analyze net sales without the impact of changes in foreign currency rates.

EBITDA

EBITDA is a non-GAAP financial measure, which we calculate by adding interest income (expense), net; income tax expense (benefit); and depreciation and amortization to net income. EBITDA provides management with additional insight to its results of operations. EBITDA is the primary metric used by our Chief Operating Decision Maker in managing our business.

Adjusted EBITDA, Adjusted Net Income (Loss) and Adjusted EPS

These non-GAAP financial measures provide management with additional insight to its results of operations and reflect the exclusion of the following items:

  • Share-based compensation expense – costs related to our share-based compensation plans, which include stock options, restricted stock, performance-based or market-based restricted stock, and our stock purchase plan; see the share-based compensation footnote in our Form 10-Q for the quarter ended September 30, 2022 for an allocation of these costs by consolidated statement of operations line item; note that certain share-based compensation costs are instead included within medical device regulation for 2021 and 2022
  • Foreign exchange impact – gains and losses related to foreign currency transactions, which are recorded as other income (expense), net
  • Strategic investments – costs related to our strategic investments, such as due diligence and integration costs, which are primarily recorded as general and administrative expenses
  • Acquisition-related fair value adjustments – comprised of (i) gains and losses related to remeasurement of contingent consideration to fair value, which are recorded as operating expenses and (ii) recognized costs related to acquired in-process research and development assets, which were expensed immediately
  • Amortization of acquired intangibles – amortization of intangible assets acquired in business combinations or asset acquisitions, including items such as developed technologies, customer relationships, trade names, manufacturing agreements, and other intangible assets, which are recorded in cost of sales or operating expenses
  • Loss on investment securities – net gains or losses recognized (realized or unrealized) within other income (expense), net relating to certain of our investments
  • Legal judgments/settlements – adverse or favorable legal judgments or negotiated legal settlements, which are recorded as general and administrative expenses
  • Succession and transition charges – costs related to the transition of certain named executive officers and certain targeted restructuring costs, including any cessation and onboarding amounts, accelerated share-based compensation expense, consulting services, and other related expenses, which are primarily recorded as general and administrative expenses
  • Medical device regulation – incremental costs incurred (i) to establish initial compliance with the regulations set forth by the European Union Medical Device Regulation (“MDR”) and the U.S. Food and Drug Administration related to our currently-approved medical devices, which are recorded primarily as research and development expenses, and (ii) related to rationalization of certain product lines that we do not expect to continue to market subsequent to the effective date of these regulations, which are recorded primarily as costs of sales
  • Business interruption – COVID-19 – gains and losses related to the realized effects the COVID-19 pandemic has had on our business operations, which consist primarily of (i) certain legislative relief received as a result of the COVID-19 pandemic, (ii) costs associated with the redesign of certain products in response to supply chain disruption, and (iii) incremental costs incurred to enhance the safety and sanitation of our facilities
  • Long-term income tax rate adjustment – reflects management’s expectation of a long-term normalized effective tax rate of 27% for 2021 and 28% for the fiscal year 2022 results and outlook, which is based on current tax law and current expected adjusted income; actual reported tax expense will ultimately be based on GAAP earnings and may differ from the expected long-term normalized effective tax rate due to a variety of factors, including the resolutions of issues arising from tax audits with various tax authorities, the ability to realize deferred tax assets, and the tax impact of certain reconciling items that are excluded in determining Adjusted Net Income and Adjusted EPS

Free Cash Flow

Free cash flow is a non-GAAP financial measure, which is calculated by subtracting capital expenditures from cash flow from operating activities. Free cash flow is an important indicator of how much cash is generated or used by our normal business operations, including capital expenditures. Management uses free cash flow to measure progress on its capital efficiency and cash flow initiatives.

Usefulness and Limitations of Non-GAAP Financial Measures

Management uses non-GAAP measures to evaluate performance period-over-period, analyze the underlying trends in our business, assess performance relative to competitors, and establish operational goals and forecasts that are used in allocating resources. Management uses these non-GAAP measures as the basis for evaluating the ability of the underlying operations to generate cash. In addition, management uses these non-GAAP measures to further its understanding of the performance of our business units.

Material Limitations Associated with the Use of Non-GAAP Financial Measures

The non-GAAP financial measures used in this press release may have limitations as analytical tools, and should not be considered in isolation or as a replacement for GAAP financial measures. Some of the limitations associated with the use of these non-GAAP financial measures are that they exclude items that reflect an economic cost and can have a material effect on cash flows. Similarly, certain non-cash expenses, such as share-based compensation, do not directly impact cash flows, but are part of total compensation costs accounted for under GAAP.

Compensation for Limitations Associated with Use of Non-GAAP Financial Measures

We compensate for the limitations of our non-GAAP financial measures by relying upon GAAP results to gain a complete picture of our performance. The GAAP results provide management with the ability to further understand our performance based on a defined set of criteria. Management believes that the non-GAAP measures reflect the underlying operating results of our businesses and provide an important measure of our overall performance. We provide detailed reconciliations of the non-GAAP financial measures to the most directly comparable GAAP measures above and encourage investors to review these reconciliations.

Usefulness of Non-GAAP Financial Measures to Investors

We believe that providing non-GAAP financial measures that exclude certain items provides investors with greater transparency to the information used by senior management in its financial and operational decision-making. Management believes it is important to provide investors with the same non-GAAP metrics it uses to supplement information regarding the performance and underlying trends of our business operations in order to facilitate comparisons to our historical operating results and internally evaluate the effectiveness of our operating strategies. We believe that disclosure of these non-GAAP financial measures also facilitates comparisons of our underlying operating performance with other companies in the industry that also supplement their GAAP results with non-GAAP financial measures.

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