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Orthofix Reports Second Quarter 2021 Results

  • Net sales of $121 million, up 66% compared to prior year and 5% compared to the second quarter of 2019
  • U.S. Spinal Implants net sales grew 56% compared to prior year and 37% over the second quarter of 2019
  • Strong performance from our U.S. M6-C™ artificial cervical disc and FITBONE® limb lengthening system with approximately $9 million in combined sales
  • Company raises full year 2021 revenue and adjusted EBITDA guidance

Orthofix Medical Inc. (NASDAQ:OFIX) today reported its financial results for the quarter ended June 30, 2021. Net sales were $121 million, earnings per share (“EPS”) was $0.12, and adjusted EPS was $0.32.

“We are proud of our second quarter performance, in which we delivered accelerated topline growth sequentially and over pre-COVID levels,” said Orthofix President and Chief Executive Officer Jon Serbousek. “We continue to see the positive impacts of our strategic initiatives, including increased product adoption driven through our expanded pool of strategic distribution partners, as well as ongoing strength from new products, in particular our M6-C™ artificial cervical disc and the FITBONE® lengthening nail.”

“Into the back half of the year, we will maintain focus on our near-term growth drivers, the M6-C artificial cervical disc, the FITBONE limb lengthening system, and our recently bolstered 3D-printed titanium spinal interbody portfolio. In addition, we will continue to invest in initiatives that will drive growth in the coming quarters, such as the expansion of our biologics portfolio with products like the recently-launched fiberFUSE™ Strip, and the development of innovative new bone growth therapy products for spine and orthopedics.”

Financial Results Overview

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

 

 

Three Months Ended June 30,

 

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

 

2021

 

 

2020

 

 

2019

 

 

2021 vs. 2020 Constant Currency Change

 

 

2021 vs. 2019 Constant Currency Change

 

Bone Growth Therapies

 

$

49,706

 

 

$

28,379

 

 

$

50,109

 

 

 

75.2

%

 

 

(0.8

%)

Spinal Implants

 

 

30,092

 

 

 

18,594

 

 

 

23,226

 

 

 

60.6

%

 

 

28.8

%

Biologics

 

 

14,852

 

 

 

11,125

 

 

 

16,744

 

 

 

33.5

%

 

 

(11.3

%)

Global Spine

 

 

94,650

 

 

 

58,098

 

 

 

90,079

 

 

 

62.5

%

 

 

4.9

%

Global Orthopedics

 

 

26,744

 

 

 

15,037

 

 

 

25,771

 

 

 

66.0

%

 

 

(0.6

%)

Net sales

 

$

121,394

 

 

$

73,135

 

 

$

115,850

 

 

 

63.2

%

 

 

3.7

%

Gross profit increased $44.0 million to $94.0 million. Gross margin increased to 77.4% compared to 68.3% in the prior year period.

Net income was $2.4 million, or $0.12 per share, compared to net loss of $(18.4) million, or $(0.96) per share in the prior year period. Adjusted net income was $6.3 million, or $0.32 per share, compared to adjusted net loss of $(11.3) million, or $(0.59) per share in the prior year period.

EBITDA was $12.8 million, compared to $(9.0) million in the prior year period. Adjusted EBITDA was $18.4 million, or 15.1% of net sales, compared to $(5.6) million, or (7.6)% of net sales, in the prior year period.

Liquidity

As of June 30, 2021, cash, cash equivalents, and restricted cash totaled $80.5 million compared to $96.8 million as of December 31, 2020. As of June 30, 2021, the Company had no borrowings under its five year $300 million secured revolving credit facility. Cash flow from operations decreased $29.8 million to $0.3 million, while free cash flow decreased $30.3 million to $(9.5) million. Based primarily on the growth in M6-C artificial cervical disc sales volumes in the U.S., the company triggered a $15.0 million milestone payment during the first quarter in relation to its 2018 acquisition of Spinal Kinetics. This payment was made during the second quarter of 2021.

Business Outlook

The Company continues to monitor and evaluate the impact the global response to the COVID-19 pandemic has had, and will continue to have, on its operations and financial results. As of the date hereof, the Company expects the following net sales results for the year ended December 31, 2021. These projections also include the impact of any expected changes in foreign currency exchange rates.

 

 

Current 2021 Outlook

 

 

Previous 2021 Outlook

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

 

Low

 

 

High

 

 

Low

High

Net sales

 

$

468.0

 

1

$

474.0

 

1

$

455.0

 

 

$

465.0

 

 

Adjusted EBITDA

 

$

58.0

 

2

$

61.0

 

2

$

52.0

 

 

$

56.0

 

 

Adjusted EPS

 

$

0.74

 

3

$

0.82

 

3

$

0.52

 

 

$

0.62

 

 

1

 

Represents a year-over-year increase of 15.1% to 16.6% on a reported basis

2

 

Represents a year-over-year increase of 21.8% to 28.1%

3

 

Represents a year-over-year increase of 184.6% to 215.4%

The Company does not provide U.S. GAAP financial measures, other than net sales, on a forward-looking basis because the Company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses, accounting fair value adjustments, and other such items without unreasonable effort. 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 second quarter of 2021. Interested parties may access the conference call by dialing (833) 670-0709 in the U.S. and (343) 761-2533 outside the U.S., and referencing the conference ID 4363197. A replay of the call will be available for three weeks by dialing (800) 585-8367 in the U.S. and (416) 621-4642 outside the U.S., and entering the conference ID 4363197. A webcast of the conference call may be accessed at ir.Orthofix.com.

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, 2020 (the “2020 Form 10-K”). 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, including (A) surgeries that use our products being delayed or cancelled as a result of hospitals and surgery centers being closed or limited to life-threatening and/or essential procedures, (B) portions of our global workforce being unable to work fully and/or effectively due to illness, quarantines, government actions (including "shelter in place" orders or advisories), facility closures or other reasons related to the pandemic, (C) disruptions to our supply chain, (D) customers and payors being unable to satisfy contractual obligations to us, including the ability to make timely payment for purchases, (E) general economic weakness in markets in which we operate affecting customer spending, and (F) other unpredictable aspects of the pandemic; (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, and (viii) 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 2020 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

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

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

 

2021

 

 

2020

 

 

2021

 

 

2020

 

 

 

(unaudited)

 

 

 

 

Net sales

 

$

121,394

 

 

$

73,135

 

 

$

226,987

 

 

$

177,958

 

Cost of sales

 

 

27,439

 

 

 

23,166

 

 

 

53,353

 

 

 

46,575

 

Gross profit

 

 

93,955

 

 

 

49,969

 

 

 

173,634

 

 

 

131,383

 

Sales and marketing

 

 

57,338

 

 

 

43,479

 

 

 

108,123

 

 

 

97,792

 

General and administrative

 

 

18,335

 

 

 

15,047

 

 

 

34,779

 

 

 

32,912

 

Research and development

 

 

13,121

 

 

 

8,765

 

 

 

24,018

 

 

 

18,729

 

Acquisition-related amortization and remeasurement

 

 

894

 

 

 

3,678

 

 

 

5,363

 

 

 

(3,904

)

Operating income (loss)

 

 

4,267

 

 

 

(21,000

)

 

 

1,351

 

 

 

(14,146

)

Interest expense, net

 

 

(550

)

 

 

(901

)

 

 

(967

)

 

 

(1,324

)

Other income (expense), net

 

 

951

 

 

 

5,069

 

 

 

(1,739

)

 

 

4,271

 

Income (loss) before income taxes

 

 

4,668

 

 

 

(16,832

)

 

 

(1,355

)

 

 

(11,199

)

Income tax benefit (expense)

 

 

(2,248

)

 

 

(1,592

)

 

 

(2,041

)

 

 

18,440

 

Net income (loss)

 

$

2,420

 

 

$

(18,424

)

 

$

(3,396

)

 

$

7,241

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) per common share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

0.12

 

 

$

(0.96

)

 

$

(0.17

)

 

$

0.38

 

Diluted

 

 

0.12

 

 

 

(0.96

)

 

 

(0.17

)

 

 

0.37

 

Weighted average number of common shares:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

19,650,610

 

 

 

19,215,392

 

 

 

19,575,127

 

 

 

19,149,523

 

Diluted

 

 

19,938,392

 

 

 

19,215,392

 

 

 

19,575,127

 

 

 

19,271,467

 

ORTHOFIX MEDICAL INC.

Condensed Consolidated Balance Sheets

 

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

 

June 30,

2021

 

 

December 31,

2020

 

 

 

(unaudited)

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

79,968

 

 

$

96,291

 

Restricted cash

 

 

554

 

 

 

530

 

Accounts receivable, net of allowances of $4,471 and $4,848, respectively

 

 

73,453

 

 

 

72,423

 

Inventories

 

 

81,551

 

 

 

84,635

 

Prepaid expenses and other current assets

 

 

22,926

 

 

 

16,500

 

Total current assets

 

 

258,452

 

 

 

270,379

 

Property, plant and equipment, net

 

 

62,268

 

 

 

63,613

 

Intangible assets, net

 

 

55,890

 

 

 

60,517

 

Goodwill

 

 

83,646

 

 

 

84,018

 

Deferred income taxes

 

 

21,239

 

 

 

25,042

 

Other long-term assets

 

 

20,515

 

 

 

22,292

 

Total assets

 

$

502,010

 

 

$

525,861

 

Liabilities and shareholders’ equity

 

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

 

 

Accounts payable

 

$

20,095

 

 

$

23,118

 

Current portion of finance lease liability

 

 

2,551

 

 

 

510

 

Other current liabilities

 

 

59,000

 

 

 

80,271

 

Total current liabilities

 

 

81,646

 

 

 

103,899

 

Long-term portion of finance lease liability

 

 

20,193

 

 

 

22,338

 

Other long-term liabilities

 

 

37,887

 

 

 

42,760

 

Total liabilities

 

 

139,726

 

 

 

168,997

 

Contingencies

 

 

 

 

 

 

 

 

Shareholders’ equity

 

 

 

 

 

 

 

 

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

19,669,129 and 19,423,874 issued and outstanding as of June 30,

2021 and December 31, 2020, respectively

 

 

1,967

 

 

 

1,942

 

Additional paid-in capital

 

 

302,736

 

 

 

292,291

 

Retained earnings

 

 

55,983

 

 

 

59,379

 

Accumulated other comprehensive income

 

 

1,598

 

 

 

3,252

 

Total shareholders’ equity

 

 

362,284

 

 

 

356,864

 

Total liabilities and shareholders’ equity

 

$

502,010

 

 

$

525,861

 

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," "Adjusted EPS," and "Free cash flow" that exclude items specified in the tables. 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.

EBITDA and Adjusted EBITDA

 

 

Three Months Ended June 30, 2021

 

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

 

Global Spine

 

 

Global Orthopedics

 

 

Corporate

 

 

Total Orthofix

 

Operating income (loss)

 

$

14,212

 

 

$

(1,037

)

 

$

(8,908

)

 

$

4,267

 

Other income (expense), net

 

 

398

 

 

 

645

 

 

 

(92

)

 

 

951

 

Depreciation and amortization

 

 

2,638

 

 

 

1,716

 

 

 

970

 

 

 

5,324

 

Amortization of acquired intangibles

 

 

1,784

 

 

 

451

 

 

 

 

 

 

2,235

 

EBITDA

 

$

19,032

 

 

$

1,775

 

 

$

(8,030

)

 

$

12,777

 

Share-based compensation

 

 

1,618

 

 

 

606

 

 

 

1,676

 

 

 

3,900

 

Foreign exchange impact

 

 

(378

)

 

 

(775

)

 

 

92

 

 

 

(1,061

)

Strategic investments

 

 

152

 

 

 

634

 

 

 

364

 

 

 

1,150

 

Acquisition-related fair value adjustments

 

 

(714

)

 

 

 

 

 

(375

)

 

 

(1,089

)

Legal judgments/settlements

 

 

1

 

 

 

59

 

 

 

1

 

 

 

61

 

Succession and transition charges

 

 

392

 

 

 

62

 

 

 

159

 

 

 

613

 

Medical device regulation

 

 

602

 

 

 

559

 

 

 

826

 

 

 

1,987

 

Business interruption - COVID-19

 

 

4

 

 

 

10

 

 

 

12

 

 

 

26

 

Adjusted EBITDA

 

$

20,709

 

 

$

2,930

 

 

$

(5,275

)

 

$

18,364

 

 

 

Six Months Ended June 30, 2021

 

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

 

Global Spine

 

 

Global Orthopedics

 

 

Corporate

 

 

Total Orthofix

 

Operating income (loss)

 

$

22,324

 

 

$

(3,899

)

 

$

(17,074

)

 

$

1,351

 

Other income (expense), net

 

 

(218

)

 

 

(793

)

 

 

(728

)

 

 

(1,739

)

Depreciation and amortization

 

 

5,252

 

 

 

3,337

 

 

 

1,943

 

 

 

10,532

 

Amortization of acquired intangibles

 

 

3,569

 

 

 

901

 

 

 

 

 

 

4,470

 

EBITDA

 

$

30,927

 

 

$

(454

)

 

$

(15,859

)

 

$

14,614

 

Share-based compensation

 

 

3,126

 

 

 

1,132

 

 

 

3,363

 

 

 

7,621

 

Foreign exchange impact

 

 

246

 

 

 

626

 

 

 

729

 

 

 

1,601

 

Strategic investments

 

 

152

 

 

 

1,734

 

 

 

675

 

 

 

2,561

 

Acquisition-related fair value adjustments

 

 

1,850

 

 

 

 

 

 

(375

)

 

 

1,475

 

Legal judgments/settlements

 

 

(50

)

 

 

105

 

 

 

(53

)

 

 

2

 

Succession and transition charges

 

 

422

 

 

 

62

 

 

 

159

 

 

 

643

 

Medical device regulation

 

 

1,105

 

 

 

1,066

 

 

 

1,640

 

 

 

3,811

 

Business interruption - COVID-19

 

 

6

 

 

 

16

 

 

 

25

 

 

 

47

 

Adjusted EBITDA

 

$

37,784

 

 

$

4,287

 

 

$

(9,696

)

 

$

32,375

 

 

 

Three Months Ended June 30, 2020

 

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

 

Global Spine

 

 

Global Orthopedics

 

 

Corporate

 

 

Total Orthofix

 

Operating income (loss)

 

$

(7,927

)

 

$

(5,373

)

 

$

(7,700

)

 

$

(21,000

)

Other income (expense), net

 

 

160

 

 

 

214

 

 

 

4,695

 

 

 

5,069

 

Depreciation and amortization

 

 

2,650

 

 

 

1,632

 

 

 

1,082

 

 

 

5,364

 

Amortization of acquired intangibles

 

 

1,410

 

 

 

168

 

 

 

 

 

 

1,578

 

EBITDA

 

$

(3,707

)

 

$

(3,359

)

 

$

(1,923

)

 

$

(8,989

)

Share-based compensation

 

 

1,568

 

 

 

529

 

 

 

1,757

 

 

 

3,854

 

Foreign exchange impact

 

 

(137

)

 

 

(286

)

 

 

(42

)

 

 

(465

)

Strategic investments

 

 

3

 

 

 

248

 

 

 

281

 

 

 

532

 

Acquisition-related fair value adjustments

 

 

2,100

 

 

 

48

 

 

 

 

 

 

2,148

 

Loss on investment securities

 

 

 

 

 

 

 

 

 

 

 

 

Legal judgments/settlements

 

 

(21

)

 

 

58

 

 

 

(3

)

 

 

34

 

Succession and transition charges

 

 

948

 

 

 

(1

)

 

 

250

 

 

 

1,197

 

Medical device regulation

 

 

149

 

 

 

143

 

 

 

180

 

 

 

472

 

Business interruption - COVID-19

 

 

8

 

 

 

86

 

 

 

(4,435

)

 

 

(4,341

)

Adjusted EBITDA

 

$

911

 

 

$

(2,534

)

 

$

(3,935

)

 

$

(5,558

)

 

 

Six Months Ended June 30, 2020

 

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

 

Global Spine

 

 

Global Orthopedics

 

 

Corporate

 

 

Total Orthofix

 

Operating income (loss)

 

$

10,632

 

 

$

(8,079

)

 

$

(16,699

)

 

$

(14,146

)

Other income (expense), net

 

 

135

 

 

 

(327

)

 

 

4,463

 

 

 

4,271

 

Depreciation and amortization

 

 

5,115

 

 

 

2,985

 

 

 

2,173

 

 

 

10,273

 

Amortization of acquired intangibles

 

 

2,828

 

 

 

168

 

 

 

 

 

 

2,996

 

EBITDA

 

$

18,710

 

 

$

(5,253

)

 

$

(10,063

)

 

$

3,394

 

Share-based compensation

 

 

3,092

 

 

 

1,155

 

 

 

3,366

 

 

 

7,613

 

Foreign exchange impact

 

 

(86

)

 

 

223

 

 

 

(29

)

 

 

108

 

Strategic investments

 

 

15

 

 

 

256

 

 

 

726

 

 

 

997

 

Acquisition-related fair value adjustments

 

 

(6,900

)

 

 

48

 

 

 

 

 

 

(6,852

)

Loss on investment securities

 

 

 

 

 

 

 

 

219

 

 

 

219

 

Legal judgments/settlements

 

 

(452

)

 

 

279

 

 

 

373

 

 

 

200

 

Succession and transition charges

 

 

1,081

 

 

 

1,098

 

 

 

684

 

 

 

2,863

 

Medical device regulation

 

 

354

 

 

 

292

 

 

 

479

 

 

 

1,125

 

Business interruption - COVID-19

 

 

341

 

 

 

265

 

 

 

(4,424

)

 

 

(3,818

)

Adjusted EBITDA

 

$

16,155

 

 

$

(1,637

)

 

$

(8,669

)

 

$

5,849

 

Adjusted Net Income

 

 

Three Months Ended

June 30,

 

 

Six Months Ended

June 30,

 

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

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Net income (loss)

 

$

2,420

 

 

$

(18,424

)

 

$

(3,396

)

 

$

7,241

 

Foreign exchange impact

 

 

(1,061

)

 

 

(465

)

 

 

1,601

 

 

 

108

 

Strategic investments

 

 

1,181

 

 

 

532

 

 

 

2,633

 

 

 

997

 

Acquisition-related fair value adjustments

 

 

(1,089

)

 

 

2,148

 

 

 

1,475

 

 

 

(6,852

)

Amortization of acquired intangibles

 

 

2,242

 

 

 

1,846

 

 

 

4,481

 

 

 

3,264

 

Loss on investment securities

 

 

 

 

 

 

 

 

 

 

 

219

 

Legal judgments/settlements

 

 

61

 

 

 

34

 

 

 

2

 

 

 

200

 

Succession and transition charges

 

 

613

 

 

 

1,197

 

 

 

643

 

 

 

2,863

 

Medical device regulation

 

 

1,987

 

 

 

472

 

 

 

3,811

 

 

 

1,125

 

Business interruption - COVID-19

 

 

28

 

 

 

(4,341

)

 

 

51

 

 

 

(3,818

)

Long-term income tax rate adjustment

 

 

(82

)

 

 

5,751

 

 

 

(1,562

)

 

 

(14,906

)

Adjusted net income (loss)

 

$

6,300

 

 

$

(11,250

)

 

$

9,739

 

 

$

(9,559

)

Adjusted EPS

 

 

Three Months Ended

June 30,

 

 

Six Months Ended

June 30,

 

(Unaudited, per diluted share)

 

2021

 

 

2020

 

 

2021

 

 

2020

 

EPS

 

$

0.12

 

 

$

(0.96

)

 

$

(0.17

)

 

$

0.37

 

Foreign exchange impact

 

 

(0.05

)

 

 

(0.02

)

 

 

0.08

 

 

 

0.01

 

Strategic investments

 

 

0.06

 

 

 

0.03

 

 

 

0.13

 

 

 

0.05

 

Acquisition-related fair value adjustments

 

 

(0.05

)

 

 

0.11

 

 

 

0.08

 

 

 

(0.36

)

Amortization of acquired intangibles

 

 

0.11

 

 

 

0.10

 

 

 

0.22

 

 

 

0.17

 

Loss on investment securities

 

 

 

 

 

 

 

 

 

 

 

0.01

 

Legal judgments/settlements

 

 

 

 

 

 

 

 

 

 

 

0.01

 

Succession and transition charges

 

 

0.03

 

 

 

0.06

 

 

 

0.03

 

 

 

0.15

 

Medical device regulation

 

 

0.10

 

 

 

0.02

 

 

 

0.19

 

 

 

0.06

 

Business interruption - COVID-19

 

 

 

 

 

(0.23

)

 

 

 

 

 

(0.20

)

Long-term income tax rate adjustment

 

 

 

 

 

0.30

 

 

 

(0.07

)

 

 

(0.77

)

Adjusted EPS

 

$

0.32

 

 

$

(0.59

)

 

$

0.49

 

 

$

(0.50

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

19,955,600

 

 

 

19,215,392

 

 

 

19,939,557

 

 

 

19,149,523

 

Free Cash Flow

 

 

Six Months Ended

June 30,

 

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

 

2021

 

 

2020

 

 

 

 

 

 

 

 

 

 

Net cash from operating activities

 

$

264

 

 

$

30,094

 

Capital expenditures

 

 

(9,792

)

 

 

(9,332

)

Free cash flow

 

$

(9,528

)

 

$

20,762

 

Constant Currency

Constant currency is a non-GAAP measure, which is calculated 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 is calculated 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 and Adjusted EPS

These non-GAAP financial measures provide management with additional insight to its results of operations and are calculated using the following adjustments:

  • Share-based compensation – costs related to our share-based compensation plans, which include stock options, restricted stock, market-based restricted stock awards and our stock purchase plan; see the share-based compensation footnote in our Form 10-Q for the quarter ended June 30, 2021 for an allocation of these costs by consolidated statement of income line item; note that certain share-based compensation costs are instead included within succession and transition charges for 2020 and medical device regulation for 2021
  • 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, ii) the amortization of an adjustment made to inventory acquired to reflect the expected selling price of the acquired inventory less the cost of expected selling efforts and a reasonable profit allowance for the selling effort for finished goods inventory, which is recorded as cost of sales, and iii) costs recognized 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 primarily consist of i) incremental costs incurred to enhance the safety and sanitation of our facilities in response to COVID-19, which are primarily reported in general and administrative expenses, and ii) inventory reserve adjustments in 2020 related to products that were set to expire, which were reflected in cost of sales
  • Long-term income tax rate adjustment – reflects management’s expectation of a long-term normalized effective tax rate of 27% for 2020 and 2021 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 as a measure of 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, to analyze the underlying trends in our business, to assess performance relative to competitors and to establish operational goals and forecasts that are used in allocating resources. Management uses these non-GAAP measures as the basis for assessing 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 the ability to understand our performance based on a defined set of criteria. The non-GAAP measures reflect the underlying operating results of our businesses, which we believe is an important measure of our overall performance. We provide a detailed reconciliation of the non-GAAP financial measures to our most directly comparable GAAP measures, and encourage investors to review this reconciliation.

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 its historical operating results and internally evaluate the effectiveness of our operating strategies. 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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