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Orthofix Reports Second Quarter 2019 Results

August 5, 2019 4:01 PM

LEWISVILLE, Texas--(BUSINESS WIRE)-- Orthofix Medical Inc. (NASDAQ: OFIX) today reported its financial results for the second quarter ended June 30, 2019. Net sales were $115.9 million, loss per share (“EPS”) was ($0.03) and adjusted EPS was $0.28.

“First and foremost, I am very pleased to announce that Jon Serbousek, a highly regarded and seasoned orthopedic and spine executive, has joined the Orthofix executive team. For more details, please see the press release we will issue today on the announcement,” said Brad Mason, Orthofix President and Chief Executive Officer. “Regarding the second quarter results, net sales were in line with our expectations, led by another quarter of outstanding performance in our Biologics products and notably, as reported by SmartTRAK®, Orthofix now has the number one market share position in the U.S. cellular allograft segment.”

Mason continued, “I am also happy to report that the launch of the M6-C™ cervical disc in the U.S. is going very well and ahead of plan. With fewer than two dozen surgeons implanting discs to date, we’ve generated $500,000 in sales since June 1st and expect to end the year with more than 150 surgeons trained. This gives us great confidence that we will meet or exceed our sales expectations for 2019 and exit the year on a strong growth trajectory.”

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)

2019

2018

Change

Constant

Currency

Change

Bone Growth Therapies

$

50,109

$

48,211

3.9

%

3.9

%

Spinal Implants

23,226

23,880

(2.7

%)

(2.0

%)

Biologics

16,744

14,668

14.2

%

14.2

%

Global Spine

90,079

86,759

3.8

%

4.0

%

Global Extremities

25,771

24,788

4.0

%

8.5

%

Net sales

$

115,850

$

111,547

3.9

%

5.0

%

Gross profit increased $1.3 million to $90.0 million. Gross margin decreased to 77.7% compared to 79.5% in the prior year period, primarily due to higher than normal charges related to the buildup of Spinal Implants inventory to support sales growth from our new sales partners in key geographies.

Net loss was ($0.5) million, or ($0.03) per share, compared to net income of $0.9 million, or $0.05 per share in the prior year period. Adjusted net income from continuing operations was $5.5 million, or $0.28 per share, compared to adjusted net income of $8.0 million, or $0.42 per share in the prior year period.

EBITDA was $6.4 million, compared to $6.8 million in the prior year period. Adjusted EBITDA was $17.3 million, or 14.9% of net sales, compared to $22.0 million, or 19.7% of net sales, in the prior year period.

Liquidity

As of June 30, 2019, cash, cash equivalents, and restricted cash totaled $52.1 million compared to $72.2 million as of December 31, 2018. As of June 30, 2019, the Company had no outstanding indebtedness and borrowing capacity of $125 million under its existing credit facility. Cash flow from operations for the six months ended June 30, 2019 decreased $4.7 million to $8.3 million when compared to the prior year period, while free cash flow decreased $8.4 million to ($2.0) million.

2019 Outlook

For the year ending December 31, 2019, the Company expects the following results, assuming exchange rates are the same as those currently prevailing.

Previous 2019 Outlook

Current 2019 Outlook

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

Low

High

Low

High

Net sales

$

472.0

$

477.0

$

472.0

1

$

477.0

1

Net income

$

14.6

$

15.5

$

12.7

2

$

13.6

2

Adjusted EBITDA

$

86.0

$

89.0

$

86.0

3

$

89.0

3

EPS

$

0.75

$

0.80

$

0.66

4

$

0.70

4

Adjusted EPS

$

1.75

$

1.82

$

1.75

5

$

1.82

5

1

Represents a year-over-year increase of 4.2% to 5.3% on a reported basis

2

Represents a year-over-year decrease of 8.0% to 1.5%

3

Represents a year-over-year decrease of 1.8% to a year-over-year increase of 1.6%

4

Represents a year-over-year decrease of 8.3% to 2.8%

5

Represents a year-over-year decrease of 2.2% to year-over-year increase of 1.7%

Conference Call

Orthofix will host a conference call today at 4:30 PM Eastern time to discuss the Company's financial results for the second quarter of 2019. Interested parties may access the conference call by dialing (844) 809-1992 in the U.S. and (612) 979-9886 outside the U.S., and referencing the conference ID 1534617. A replay of the call will be available for two weeks by dialing (855) 859-2056 in the U.S. and (404) 537-3406 outside the U.S., and entering the conference ID 1534617. A webcast of the conference call may be accessed by going to the Company's website at www.orthofix.com, by clicking on the Investors link and then the Events and Presentations page.

About Orthofix

Orthofix Medical Inc. is a global medical device company focused on musculoskeletal products and therapies. The Company’s mission is to improve patients' lives by providing superior reconstruction and regenerative musculoskeletal solutions to physicians worldwide. Headquartered in Lewisville, Texas, Orthofix’s spine and orthopedic extremities products are distributed in over 70 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 (“the Exchange Act”), 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. Therefore, 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 further update any such statement, or the risk factors described in Part I, Item 1A under the heading Risk Factors in our Form 10-K for the year ended December 31, 2018, to reflect new information, the occurrence of future events or circumstances or otherwise.

1 Per SmartTRAK Q1/19 Market Recap: OrthoBio Report, US Stem Cell segment

ORTHOFIX MEDICAL INC.

Condensed Consolidated Statements of Operations

Three Months Ended

Six Months Ended

June 30,

June 30,

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

2019

2018

2019

2018

Net sales

$

115,850

$

111,547

$

224,962

$

220,256

Cost of sales

25,812

22,835

49,520

46,982

Gross profit

90,038

88,712

175,442

173,274

Sales and marketing

56,864

51,529

110,558

101,797

General and administrative

21,935

21,958

42,407

41,382

Research and development

8,980

7,891

18,209

14,828

Acquisition-related amortization and remeasurement

1,808

1,419

8,265

1,482

Operating income (loss)

451

5,915

(3,997

)

13,785

Interest income (expense), net

457

(251

)

200

(434

)

Other expense, net

(236

)

(3,643

)

(640

)

(731

)

Income (loss) before income taxes

672

2,021

(4,437

)

12,620

Income tax benefit (expense)

(1,219

)

(1,096

)

4,787

(6,469

)

Net income (loss)

$

(547

)

$

925

$

350

$

6,151

Net income (loss) per common share:

Basic

$

(0.03

)

$

0.05

$

0.02

$

0.33

Diluted

(0.03

)

0.05

0.02

0.32

Weighted average number of common shares:

Basic

18,834,886

18,413,756

18,790,612

18,409,331

Diluted

18,834,886

18,835,560

19,179,057

18,811,356

ORTHOFIX MEDICAL INC.

Condensed Consolidated Balance Sheets

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

June 30,

2019

December 31,

2018

(unaudited)

Assets

Current assets

Cash and cash equivalents

$

52,143

$

69,623

Restricted cash

2,566

Trade accounts receivable, net of allowances of $4,205 and $7,463, respectively

80,591

77,747

Inventories

79,141

76,847

Prepaid expenses and other current assets

20,954

17,856

Total current assets

232,829

244,639

Property, plant and equipment, net

64,402

42,835

Intangible assets, net

55,628

51,897

Goodwill

71,177

72,401

Deferred income taxes

37,566

33,228

Other long-term assets

27,204

21,641

Total assets

$

488,806

$

466,641

Liabilities and shareholders’ equity

Current liabilities

Trade accounts payable

$

19,523

$

17,989

Current portion of finance lease liability

301

Other current liabilities

48,161

67,919

Total current liabilities

67,985

85,908

Long-term portion of finance lease liability

20,847

Other long-term liabilities

52,180

45,336

Total liabilities

141,012

131,244

Contingencies

Shareholders’ equity

Common shares $0.10 par value; 50,000,000 shares authorized; 18,831,581 and

18,579,688 issued and outstanding as of June 30, 2019 and December 31, 2018,

respectively

1,883

1,858

Additional paid-in capital

257,888

243,165

Retained earnings

86,561

87,078

Accumulated other comprehensive income

1,462

3,296

Total shareholders’ equity

347,794

335,397

Total liabilities and shareholders’ equity

$

488,806

$

466,641

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, 2019

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

Global Spine

Global Extremities

Corporate

Total Orthofix

Operating income (loss)

$

12,696

$

1,353

$

(13,598

)

$

451

Other income (expense), net

175

71

(482

)

(236

)

Depreciation and amortization

2,314

1,326

1,200

4,840

Amortization of acquired intangibles

1,338

1,338

EBITDA

$

16,523

$

2,750

$

(12,880

)

$

6,393

Share-based compensation

1,733

607

2,454

4,794

Foreign exchange impact

(168

)

(116

)

1

(283

)

Strategic investments

591

4,234

4,825

Acquisition-related fair value adjustments

647

647

Loss on investment securities

491

491

Legal judgments/settlements

(555

)

(318

)

(4

)

(877

)

Succession charges

132

1,136

1,268

Adjusted EBITDA

$

18,903

$

2,923

$

(4,568

)

$

17,258

Six Months Ended June 30, 2019

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

Global Spine

Global Extremities

Corporate

Total Orthofix

Operating income (loss)

$

20,426

$

358

$

(24,781

)

$

(3,997

)

Other income (expense), net

(224

)

(407

)

(9

)

(640

)

Depreciation and amortization

4,501

2,626

2,383

9,510

Amortization of acquired intangibles

2,395

2,395

EBITDA

$

27,098

$

2,577

$

(22,407

)

$

7,268

Share-based compensation

3,313

1,133

3,907

8,353

Foreign exchange impact

225

342

23

590

Strategic investments

1,249

5,645

6,894

Acquisition-related fair value adjustments

6,579

6,579

Loss on investment securities

Legal judgments/settlements

(500

)

(273

)

21

(752

)

Succession charges

132

3,868

4,000

Adjusted EBITDA

$

38,096

$

3,779

$

(8,943

)

$

32,932

Three Months Ended June 30, 2018

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

Global Spine

Global Extremities

Corporate

Total Orthofix

Operating income (loss)

$

17,240

$

878

$

(12,203

)

$

5,915

Other income (expense), net

(544

)

(1,675

)

(1,424

)

(3,643

)

Depreciation and amortization

2,024

1,285

935

4,244

Amortization of acquired intangibles

310

310

EBITDA

$

19,030

$

488

$

(12,692

)

$

6,826

Share-based compensation

1,836

613

2,766

5,215

Foreign exchange impact

456

1,626

1,173

3,255

Strategic investments

812

3,837

4,649

Acquisition-related fair value adjustments

1,473

1,473

Loss on investment securities

230

230

Legal judgments/settlements

212

87

75

374

Succession charges

Adjusted EBITDA

$

23,819

$

2,814

$

(4,611

)

$

22,022

Six Months Ended June 30, 2018

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

Global Spine

Global Extremities

Corporate

Total Orthofix

Operating income (loss)

$

34,007

$

2,721

$

(22,943

)

$

13,785

Other income (expense), net

(564

)

(1,486

)

1,319

(731

)

Depreciation and amortization

4,039

2,581

1,930

8,550

Amortization of acquired intangibles

373

373

EBITDA

$

37,855

$

3,816

$

(19,694

)

$

21,977

Share-based compensation

3,236

1,120

4,775

9,131

Foreign exchange impact

433

1,485

261

2,179

Strategic investments

812

7,054

7,866

Acquisition-related fair value adjustments

1,473

1,473

Gain on investment securities

(1,399

)

(1,399

)

Legal judgments/settlements

179

294

48

521

Succession charges

Adjusted EBITDA

$

43,988

$

6,715

$

(8,955

)

$

41,748

Adjusted Net Income

Three Months Ended

June 30,

Six Months Ended

June 30,

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

2019

2018

2019

2018

Net income (loss)

$

(547

)

$

925

$

350

$

6,151

Foreign exchange impact

(283

)

3,255

590

2,179

Strategic investments

4,825

4,651

6,894

7,868

Acquisition-related fair value adjustments

647

1,473

6,579

1,473

Amortization of acquired intangibles

1,338

310

2,395

373

Interest and (gain) loss on investment securities

(96

)

230

(689

)

(1,399

)

Legal judgments/settlements

(877

)

374

(752

)

521

Succession charges

1,268

4,000

Long-term income tax rate adjustment

(804

)

(3,213

)

(8,723

)

(1,803

)

Adjusted net income

$

5,471

$

8,005

$

10,644

$

15,363

Adjusted EPS

Three Months Ended

June 30,

Six Months Ended

June 30,

(Unaudited, per diluted share)

2019

2018

2019

2018

EPS

$

(0.03

)

$

0.05

$

0.02

$

0.32

Foreign exchange impact

(0.01

)

0.17

0.03

0.12

Strategic investments

0.25

0.24

0.36

0.41

Acquisition-related fair value adjustments

0.03

0.08

0.34

0.08

Amortization of acquired intangibles

0.07

0.02

0.12

0.02

Interest and (gain) loss on investment securities

0.01

(0.04

)

(0.07

)

Legal judgments/settlements

(0.05

)

0.02

(0.04

)

0.03

Succession charges

0.07

0.21

Long-term income tax rate adjustment

(0.05

)

(0.17

)

(0.45

)

(0.10

)

Adjusted EPS

$

0.28

$

0.42

$

0.55

$

0.81

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

19,272,139

18,980,808

19,280,140

18,945,356

Free Cash Flow

Six Months Ended

June 30,

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

2019

2018

Net cash from operating activities

$

8,344

$

13,032

Capital expenditures

(10,338

)

(6,652

)

Free cash flow

$

(1,994

)

$

6,380

2019 Outlook

Previous 2019 Outlook

Current 2019 Outlook

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

Low

High

Low

High

Net income

$

14.6

$

15.5

$

12.7

$

13.6

Interest expense, net

0.8

0.9

(1.2

)

(1.2

)

Income tax expense

5.9

6.4

6.8

7.3

Depreciation and amortization

24.2

24.2

24.5

24.6

EBITDA

$

45.5

$

47.0

$

42.8

$

44.3

Share-based compensation

19.1

20.1

19.3

20.4

Foreign exchange impact

0.9

0.9

0.6

0.6

Strategic investments

4.8

4.9

8.7

8.9

Acquisition-related fair value adjustments

8.5

8.7

7.7

7.7

Interest and (gain) loss on investment securities

(0.5

)

(0.5

)

Legal judgments/settlements

1.3

1.3

(0.5

)

(0.5

)

Succession charges

6.4

6.6

7.4

7.6

Adjusted EBITDA

$

86.0

$

89.0

$

86.0

$

89.0

Previous 2019 Outlook

Current 2019 Outlook

(Unaudited, per diluted share)

Low

High

Low

High

EPS

$

0.75

$

0.80

$

0.66

$

0.70

Foreign exchange impact

0.05

0.05

0.03

0.03

Strategic investments

0.25

0.25

0.45

0.46

Acquisition-related fair value adjustments

0.44

0.45

0.40

0.40

Amortization of intangible assets

0.25

0.25

0.25

0.26

Interest and (gain) loss on investment securities

(0.03

)

(0.03

)

(0.09

)

(0.09

)

Legal judgments/settlements

0.07

0.07

(0.02

)

(0.02

)

Succession charges

0.33

0.34

0.38

0.39

Long-term income tax rate adjustment

(0.36

)

(0.36

)

(0.31

)

(0.31

)

Adjusted EPS

$

1.75

$

1.82

$

1.75

$

1.82

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

19,375,000

19,375,000

19,375,000

19,375,000

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 expense, net; income tax expense; 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:

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 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 equity 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.

Orthofix Medical Inc.

Mark Quick

P: 214-937-2924

E: [email protected]

Source: Orthofix Medical Inc.

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