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Orthofix Reports Third Quarter 2021 Results

  • Net sales of $112 million, an increase of 1.3% over the prior year period
  • Double-digit growth over the prior year period for both global Spinal Implants and Orthopedics
  • More than 1,000 U.S. surgeons trained and 60,000 M6-C artificial cervical discs implanted worldwide to date
  • Launched Opus Mg Set synthetic bone void filler
  • Submitted AccelStim PMA application for the healing of fresh fractures

Orthofix Medical Inc. (NASDAQ:OFIX) today reported its financial results for the quarter ended September 30, 2021. Net sales were $112 million, earnings per share (“EPS”) was $(0.11), and adjusted EPS was $0.10.

“I am proud of the tenacity of our team as they continue to implement our strategic initiatives despite the ongoing challenges of COVID, delivering double-digit growth in both our global Spinal Implants and Orthopedics businesses,” said Orthofix President and Chief Executive Officer Jon Serbousek. “New products remain a growth driver in the business. The strong adoption of the M6-C™ artificial cervical disc continues as we recently passed the 60,000 worldwide implant mark, and sales of our FITBONE™ limb-lengthening system have accelerated throughout the year, resulting in third quarter revenue growing 30 percent sequentially.”

“As we close out the year, we will be focused on driving top-line performance and exiting the year with mid-single digit growth. We expect this accelerated growth in the near term to come from the continued strength of the M6-C disc, the FITBONE system, and our recently bolstered 3D-printed titanium spinal interbody portfolio,” continued Serbousek. “Over the long term, we have multiple initiatives in place, including diversification of our biologics portfolio with products like Opus™ Mg Set synthetic bone void filler and the planned expansion of our bone growth therapy portfolio with the AccelStim™ ultrasound bone healing therapy for the healing of fresh and nonunion fractures. We anticipate the recent PMA application will allow us to bring this innovative offering and new indication to market in 2022.”

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)

 

2021

 

 

2020

 

 

Change

 

 

Constant

Currency

Change

 

Bone Growth Therapies

 

$

45,168

 

 

$

47,066

 

 

 

(4.0

%)

 

 

(4.0

%)

Spinal Implants

 

 

28,151

 

 

 

25,505

 

 

 

10.4

%

 

 

10.2

%

Biologics

 

 

12,806

 

 

 

15,245

 

 

 

(16.0

%)

 

 

(16.0

%)

Global Spine

 

 

86,125

 

 

 

87,816

 

 

 

(1.9

%)

 

 

(2.0

%)

Global Orthopedics

 

 

26,303

 

 

 

23,169

 

 

 

13.5

%

 

 

12.2

%

Net sales

 

$

112,428

 

 

$

110,985

 

 

 

1.3

%

 

 

1.0

%

Gross profit decreased $0.6 million to $84.1 million. Gross margin decreased to 74.8% compared to 76.4% in the prior year period.

Net loss was $(2.2) million, or $(0.11) per share, compared to net income of $4.7 million, or $0.24 per share in the prior year period. Adjusted net income was $2.0 million, or $0.10 per share, compared to adjusted net income of $6.0 million, or $0.31 per share in the prior year period.

EBITDA was $5.0 million, compared to $15.0 million in the prior year period. Adjusted EBITDA was $11.9 million, or 10.6% of net sales, compared to $19.7 million, or 17.8% of net sales, in the prior year period.

Liquidity

As of September 30, 2021, cash, cash equivalents, and restricted cash totaled $83.2 million compared to $96.8 million as of December 31, 2020. As of September 30, 2021, the Company had no borrowings under its five year $300 million secured revolving credit facility. Cash flow from operations decreased $45.3 million to $6.7 million, while free cash flow decreased $45.4 million to $(6.1) million. This decrease in cash was primarily attributable to the timing and repayment of certain funds received under the CARES Act and from a $15.0 million milestone payment made in 2021 based upon our M6-C artificial cervical disc sales volumes.

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

 

$

460.0

 

1

$

464.0

 

1

$

468.0

 

 

$

474.0

 

 

Adjusted EBITDA

 

$

57.0

 

2

$

58.0

 

2

$

58.0

 

 

$

61.0

 

 

Adjusted EPS

 

$

0.71

 

3

$

0.75

 

3

$

0.74

 

 

$

0.82

 

 

1

Represents a year-over-year increase of 13.1% to 14.1% on a reported basis

2

Represents a year-over-year increase of 19.7% to 21.8%

3

Represents a year-over-year increase of 173.1% to 188.5%

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 third 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 1889020. A replay of the call will be available for three weeks by dialing (800) 585-8367 in the U.S. or (416) 621-4642 outside the U.S., and entering the conference ID 1889020. 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

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

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

 

2021

 

 

2020

 

 

2021

 

 

2020

 

 

 

(unaudited)

 

 

 

 

Net sales

 

$

112,428

 

 

$

110,985

 

 

$

339,415

 

 

$

288,943

 

Cost of sales

 

 

28,307

 

 

 

26,243

 

 

 

81,660

 

 

 

72,818

 

Gross profit

 

 

84,121

 

 

 

84,742

 

 

 

257,755

 

 

 

216,125

 

Sales and marketing

 

 

56,097

 

 

 

52,926

 

 

 

164,220

 

 

 

150,718

 

General and administrative

 

 

16,312

 

 

 

16,541

 

 

 

51,091

 

 

 

49,453

 

Research and development

 

 

12,360

 

 

 

9,962

 

 

 

36,378

 

 

 

28,691

 

Acquisition-related amortization and remeasurement

 

 

(335

)

 

 

1,138

 

 

 

5,028

 

 

 

(2,766

)

Operating income (loss)

 

 

(313

)

 

 

4,175

 

 

 

1,038

 

 

 

(9,971

)

Interest expense, net

 

 

(433

)

 

 

(731

)

 

 

(1,400

)

 

 

(2,055

)

Other income (expense), net

 

 

(1,789

)

 

 

1,817

 

 

 

(3,528

)

 

 

6,088

 

Income (loss) before income taxes

 

 

(2,535

)

 

 

5,261

 

 

 

(3,890

)

 

 

(5,938

)

Income tax benefit (expense)

 

 

364

 

 

 

(607

)

 

 

(1,677

)

 

 

17,833

 

Net income (loss)

 

$

(2,171

)

 

$

4,654

 

 

$

(5,567

)

 

$

11,895

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) per common share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

(0.11

)

 

$

0.24

 

 

$

(0.28

)

 

$

0.62

 

Diluted

 

 

(0.11

)

 

 

0.24

 

 

 

(0.28

)

 

 

0.61

 

Weighted average number of common shares:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

19,769,823

 

 

 

19,335,718

 

 

 

19,633,782

 

 

 

19,217,057

 

Diluted

 

 

19,769,823

 

 

 

19,398,567

 

 

 

19,633,782

 

 

 

19,319,302

 

ORTHOFIX MEDICAL INC.

Condensed Consolidated Balance Sheets

 

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

 

September 30,

2021

 

 

December 31,

2020

 

 

 

(unaudited)

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

82,710

 

 

$

96,291

 

Restricted cash

 

 

505

 

 

 

530

 

Accounts receivable, net of allowances of $4,928 and $4,848, respectively

 

 

68,971

 

 

 

72,423

 

Inventories

 

 

84,678

 

 

 

84,635

 

Prepaid expenses and other current assets

 

 

23,348

 

 

 

16,500

 

Total current assets

 

 

260,212

 

 

 

270,379

 

Property, plant and equipment, net

 

 

58,784

 

 

 

63,613

 

Intangible assets, net

 

 

54,794

 

 

 

60,517

 

Goodwill

 

 

83,357

 

 

 

84,018

 

Deferred income taxes

 

 

22,745

 

 

 

25,042

 

Other long-term assets

 

 

20,503

 

 

 

22,292

 

Total assets

 

$

500,395

 

 

$

525,861

 

Liabilities and shareholders’ equity

 

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

 

 

Accounts payable

 

$

19,437

 

 

$

23,118

 

Current portion of finance lease liability

 

 

2,570

 

 

 

510

 

Other current liabilities

 

 

57,997

 

 

 

80,271

 

Total current liabilities

 

 

80,004

 

 

 

103,899

 

Long-term portion of finance lease liability

 

 

20,044

 

 

 

22,338

 

Other long-term liabilities

 

 

35,514

 

 

 

42,760

 

Total liabilities

 

 

135,562

 

 

 

168,997

 

Contingencies

 

 

 

 

 

 

 

 

Shareholders’ equity

 

 

 

 

 

 

 

 

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

19,741,410 and 19,423,874 issued and outstanding as of September 30,

2021 and December 31, 2020, respectively

 

 

1,974

 

 

 

1,942

 

Additional paid-in capital

 

 

307,783

 

 

 

292,291

 

Retained earnings

 

 

53,812

 

 

 

59,379

 

Accumulated other comprehensive income

 

 

1,264

 

 

 

3,252

 

Total shareholders’ equity

 

 

364,833

 

 

 

356,864

 

Total liabilities and shareholders’ equity

 

$

500,395

 

 

$

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 (loss)," "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 September 30, 2021

 

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

 

Global Spine

 

 

Global Orthopedics

 

 

Corporate

 

 

Total Orthofix

 

Operating income (loss)

 

$

10,042

 

 

$

(976

)

 

$

(9,379

)

 

$

(313

)

Other income (expense), net

 

 

(420

)

 

 

(1,231

)

 

 

(138

)

 

 

(1,789

)

Depreciation and amortization

 

 

2,501

 

 

 

1,571

 

 

 

854

 

 

 

4,926

 

Amortization of acquired intangibles

 

 

1,785

 

 

 

440

 

 

 

 

 

 

2,225

 

EBITDA

 

$

13,908

 

 

$

(196

)

 

$

(8,663

)

 

$

5,049

 

Share-based compensation expense

 

 

1,590

 

 

 

490

 

 

 

1,759

 

 

 

3,839

 

Foreign exchange impact

 

 

426

 

 

 

1,013

 

 

 

134

 

 

 

1,573

 

Strategic investments

 

 

242

 

 

 

319

 

 

 

761

 

 

 

1,322

 

Acquisition-related fair value adjustments

 

 

(2,300

)

 

 

 

 

 

 

 

 

(2,300

)

Legal judgments/settlements

 

 

443

 

 

 

(765

)

 

 

1

 

 

 

(321

)

Succession and transition charges

 

 

30

 

 

 

 

 

 

(9

)

 

 

21

 

Medical device regulation

 

 

640

 

 

 

501

 

 

 

971

 

 

 

2,112

 

Business interruption - COVID-19

 

 

567

 

 

 

10

 

 

 

8

 

 

 

585

 

Adjusted EBITDA

 

$

15,546

 

 

$

1,372

 

 

$

(5,038

)

 

$

11,880

 

 

 

Nine Months Ended September 30, 2021

 

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

 

Global Spine

 

 

Global Orthopedics

 

 

Corporate

 

 

Total Orthofix

 

Operating income (loss)

 

$

32,366

 

 

$

(4,875

)

 

$

(26,453

)

 

$

1,038

 

Other income (expense), net

 

 

(638

)

 

 

(2,024

)

 

 

(866

)

 

 

(3,528

)

Depreciation and amortization

 

 

7,754

 

 

 

4,906

 

 

 

2,797

 

 

 

15,457

 

Amortization of acquired intangibles

 

 

5,353

 

 

 

1,343

 

 

 

 

 

 

6,696

 

EBITDA

 

$

44,835

 

 

$

(650

)

 

$

(24,522

)

 

$

19,663

 

Share-based compensation expense

 

 

4,716

 

 

 

1,622

 

 

 

5,122

 

 

 

11,460

 

Foreign exchange impact

 

 

672

 

 

 

1,639

 

 

 

863

 

 

 

3,174

 

Strategic investments

 

 

394

 

 

 

2,053

 

 

 

1,436

 

 

 

3,883

 

Acquisition-related fair value adjustments

 

 

(450

)

 

 

 

 

 

(375

)

 

 

(825

)

Legal judgments/settlements

 

 

393

 

 

 

(660

)

 

 

(52

)

 

 

(319

)

Succession and transition charges

 

 

452

 

 

 

62

 

 

 

150

 

 

 

664

 

Medical device regulation

 

 

1,745

 

 

 

1,567

 

 

 

2,611

 

 

 

5,923

 

Business interruption - COVID-19

 

 

573

 

 

 

26

 

 

 

33

 

 

 

632

 

Adjusted EBITDA

 

$

53,330

 

 

$

5,659

 

 

$

(14,734

)

 

$

44,255

 

 

 

Three Months Ended September 30, 2020

 

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

 

Global Spine

 

 

Global Orthopedics

 

 

Corporate

 

 

Total Orthofix

 

Operating income (loss)

 

$

13,247

 

 

$

(1,687

)

 

$

(7,385

)

 

$

4,175

 

Other income (expense), net

 

 

610

 

 

 

1,077

 

 

 

130

 

 

 

1,817

 

Depreciation and amortization

 

 

4,445

 

 

 

1,434

 

 

 

1,059

 

 

 

6,938

 

Amortization of acquired intangibles

 

 

1,658

 

 

 

434

 

 

 

 

 

 

2,092

 

EBITDA

 

$

19,960

 

 

$

1,258

 

 

$

(6,196

)

 

$

15,022

 

Share-based compensation expense

 

 

1,494

 

 

 

423

 

 

 

1,925

 

 

 

3,842

 

Foreign exchange impact

 

 

(626

)

 

 

(1,125

)

 

 

(132

)

 

 

(1,883

)

Strategic investments

 

 

15

 

 

 

217

 

 

 

642

 

 

 

874

 

Acquisition-related fair value adjustments

 

 

(700

)

 

 

52

 

 

 

 

 

 

(648

)

Loss on investment securities

 

 

 

 

 

 

 

 

 

 

 

 

Legal judgments/settlements

 

 

32

 

 

 

267

 

 

 

(1

)

 

 

298

 

Succession and transition charges

 

 

941

 

 

 

304

 

 

 

78

 

 

 

1,323

 

Medical device regulation

 

 

22

 

 

 

204

 

 

 

488

 

 

 

714

 

Business interruption - COVID-19

 

 

48

 

 

 

43

 

 

 

89

 

 

 

180

 

Adjusted EBITDA

 

$

21,186

 

 

$

1,643

 

 

$

(3,107

)

 

$

19,722

 

 

 

Nine Months Ended September 30, 2020

 

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

 

Global Spine

 

 

Global Orthopedics

 

 

Corporate

 

 

Total Orthofix

 

Operating income (loss)

 

$

23,879

 

 

$

(9,766

)

 

$

(24,084

)

 

$

(9,971

)

Other income (expense), net

 

 

745

 

 

 

750

 

 

 

4,593

 

 

 

6,088

 

Depreciation and amortization

 

 

9,560

 

 

 

4,151

 

 

 

3,232

 

 

 

16,943

 

Amortization of acquired intangibles

 

 

4,486

 

 

 

870

 

 

 

 

 

 

5,356

 

EBITDA

 

$

38,670

 

 

$

(3,995

)

 

$

(16,259

)

 

$

18,416

 

Share-based compensation expense

 

 

4,586

 

 

 

1,578

 

 

 

5,291

 

 

 

11,455

 

Foreign exchange impact

 

 

(712

)

 

 

(902

)

 

 

(161

)

 

 

(1,775

)

Strategic investments

 

 

30

 

 

 

473

 

 

 

1,366

 

 

 

1,869

 

Acquisition-related fair value adjustments

 

 

(7,600

)

 

 

100

 

 

 

 

 

 

(7,500

)

Loss on investment securities

 

 

 

 

 

 

 

 

219

 

 

 

219

 

Legal judgments/settlements

 

 

(420

)

 

 

546

 

 

 

372

 

 

 

498

 

Succession and transition charges

 

 

2,022

 

 

 

1,402

 

 

 

762

 

 

 

4,186

 

Medical device regulation

 

 

376

 

 

 

496

 

 

 

967

 

 

 

1,839

 

Business interruption - COVID-19

 

 

389

 

 

 

308

 

 

 

(4,335

)

 

 

(3,638

)

Adjusted EBITDA

 

$

37,341

 

 

$

6

 

 

$

(11,778

)

 

$

25,569

 

Adjusted Net Income

 

 

Three Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

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

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Net income (loss)

 

$

(2,171

)

 

$

4,654

 

 

$

(5,567

)

 

$

11,895

 

Foreign exchange impact

 

 

1,573

 

 

 

(1,883

)

 

 

3,174

 

 

 

(1,775

)

Strategic investments

 

 

1,343

 

 

 

872

 

 

 

3,976

 

 

 

1,869

 

Acquisition-related fair value adjustments

 

 

(2,300

)

 

 

(648

)

 

 

(825

)

 

 

(7,500

)

Amortization of acquired intangibles

 

 

2,232

 

 

 

2,092

 

 

 

6,713

 

 

 

5,356

 

Loss on investment securities

 

 

 

 

 

 

 

 

 

 

 

219

 

Legal judgments/settlements

 

 

(321

)

 

 

298

 

 

 

(319

)

 

 

498

 

Succession and transition charges

 

 

21

 

 

 

1,323

 

 

 

664

 

 

 

4,186

 

Medical device regulation

 

 

2,112

 

 

 

714

 

 

 

5,923

 

 

 

1,839

 

Business interruption - COVID-19

 

 

587

 

 

 

183

 

 

 

638

 

 

 

(3,635

)

Long-term income tax rate adjustment

 

 

(1,096

)

 

 

(1,609

)

 

 

(2,658

)

 

 

(16,515

)

Adjusted net income (loss)

 

$

1,980

 

 

$

5,996

 

 

$

11,719

 

 

$

(3,563

)

Adjusted EPS

 

 

Three Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

(Unaudited, per diluted share)

 

2021

 

 

2020

 

 

2021

 

 

2020

 

EPS

 

$

(0.11

)

 

$

0.24

 

 

$

(0.28

)

 

$

0.61

 

Foreign exchange impact

 

 

0.08

 

 

 

(0.10

)

 

 

0.16

 

 

 

(0.09

)

Strategic investments

 

 

0.07

 

 

 

0.04

 

 

 

0.20

 

 

 

0.10

 

Acquisition-related fair value adjustments

 

 

(0.12

)

 

 

(0.03

)

 

 

(0.04

)

 

 

(0.39

)

Amortization of acquired intangibles

 

 

0.11

 

 

 

0.11

 

 

 

0.34

 

 

 

0.28

 

Loss on investment securities

 

 

 

 

 

 

 

 

 

 

 

0.01

 

Legal judgments/settlements

 

 

(0.02

)

 

 

0.02

 

 

 

(0.02

)

 

 

0.03

 

Succession and transition charges

 

 

 

 

 

0.07

 

 

 

0.03

 

 

 

0.22

 

Medical device regulation

 

 

0.11

 

 

 

0.04

 

 

 

0.30

 

 

 

0.10

 

Business interruption - COVID-19

 

 

0.03

 

 

 

0.01

 

 

 

0.03

 

 

 

(0.19

)

Long-term income tax rate adjustment

 

 

(0.05

)

 

 

(0.09

)

 

 

(0.13

)

 

 

(0.87

)

Adjusted EPS

 

$

0.10

 

 

$

0.31

 

 

$

0.59

 

 

$

(0.19

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

19,975,851

 

 

 

19,405,781

 

 

 

19,945,411

 

 

 

19,217,057

 

Free Cash Flow

 

 

Nine Months Ended

September 30,

 

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

 

2021

 

 

2020

 

 

 

 

 

 

 

 

 

 

Net cash from operating activities

 

$

6,696

 

 

$

51,981

 

Capital expenditures

 

 

(12,781

)

 

 

(12,704

)

Free cash flow

 

$

(6,085

)

 

$

39,277

 

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 expense – 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 September 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, (ii) costs associated with the redesign of certain products in response to supply chain disruption caused by COVID-19, and (iii) inventory reserve adjustments in 2020 related to products that were set to expire, which are 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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