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    Orthofix Reports Third Quarter 2024 Results, Reiterates Full-Year 2024 Financial Guidance, and Introduces New Three-Year Financial Targets

    11/7/24 7:05:00 AM ET
    $OFIX
    Medical/Dental Instruments
    Health Care
    Get the next $OFIX alert in real time by email

    Building on Positive Momentum from Compelling Combination of Profitable, Above-Market Growth with a Stronger Financial Profile

    Orthofix Medical Inc. (NASDAQ:OFIX), a leading global medical technology company, today reported its financial results for the third quarter ended September 30, 2024, reiterated its full-year 2024 financial guidance, and introduced new three-year financial targets.

    Recent Highlights

    • Third quarter 2024 net sales of $196.6 million, an increase of 7% on a reported and constant currency basis compared to third quarter 2023
    • U.S. Spine Fixation1 net sales growth of 18% compared to third quarter 2023, driven by distribution expansion and further penetration in existing accounts
    • Bone Growth Therapies (BGT) net sales growth of 9% and BGT Fracture net sales growth of 13% compared to third quarter 2023
    • U.S. Orthopedics delivered a record net sales quarter with net sales growth of 15% compared to third quarter of 2023
    • Company entered into record number of 7D FLASH™ Navigation System earnout agreements and matched record for highest number of 7D placements in any quarter to date
    • Third quarter 2024 net loss of $(27.4) million; Non-GAAP adjusted EBITDA of $19.2 million, an increase of $5.7 million, with adjusted EBITDA margin expanding approximately 250 basis points compared to third quarter 2023
    • Achieves free cash flow of $5.9 million in third quarter 2024, a significant improvement in cash usage compared to previous quarters
    • Announces new $275 million credit facility that replaces existing financing and further optimizes the Company's capital structure to support long-term profitable growth
    • Maintains full-year 2024 net sales guidance of $795 million to $800 million and full-year 2024 non-GAAP adjusted EBITDA guidance of $64 million to $69 million; continue to expect positive free cash flow for the second half of 2024
    • Introduces new 2027 financial targets to increase transparency and maximize value creation

    Third quarter net sales were $196.6 million, an increase of 7% on a reported and constant currency basis. Net loss was $(27.4) million and earnings per share ("EPS") was $(0.71) on a reported basis, representing an improvement of 8% when compared to the prior year period. Non-GAAP adjusted EBITDA was $19.2 million for the third quarter, an increase of $5.7 million, representing adjusted EBITDA margin expansion of approximately 250 basis points over the prior year period.

    "Our third quarter net sales results were driven by focused execution of our key growth priorities, and we also delivered strong adjusted EBITDA margin expansion and positive free cash flow, all of which we believe keeps us on a clear course to achieve our 2024 and long-term financial targets," said Massimo Calafiore, President and Chief Executive Officer. "Highlights in the quarter included year-over-year revenue growth across each of our business segments where our performance once again was led by strength in our U.S. markets, including U.S. Spine Fixation, which grew 18%, and Bone Growth Therapies, which grew 9% overall and 13% in Fracture, further highlighting the benefit of cross-selling in our integrated spine channel. Notably, our U.S. Orthopedics business delivered a record net sales quarter and grew 15% year-over-year, benefiting from strong commercial execution. In addition to reiterating our full-year 2024 financial guidance, we are also introducing our new 2027 financial targets, which reflect our confidence in sustainable growth trends, the strength of our differentiated and expanding product portfolio, which continues to win share, and our commercial strategy and execution. We are well-positioned to accelerate our positive momentum and deliver on our commitment to drive disciplined, profitable growth and innovation while increasing long-term shareholder value."

    Financial Results Overview

    Third Quarter 2024 Net Sales and Financial Results

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

     

     

    Three Months Ended September 30,

     

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

     

    2024

     

     

    2023

     

     

    Change

     

     

    Constant

    Currency

    Change

     

    Bone Growth Therapies

     

    $

    57.9

     

     

    $

    53.4

     

     

     

    8.6

    %

     

     

    8.6

    %

    Spinal Implants, Biologics and Enabling Technologies

     

     

    108.2

     

     

     

    101.0

     

     

     

    7.1

    %

     

     

    7.1

    %

    Global Spine

     

     

    166.1

     

     

     

    154.4

     

     

     

    7.6

    %

     

     

    7.6

    %

    Global Orthopedics

     

     

    30.5

     

     

     

    29.7

     

     

     

    2.9

    %

     

     

    2.5

    %

    Net sales

     

    $

    196.6

     

     

    $

    184.0

     

     

     

    6.8

    %

     

     

    6.8

    %

    Gross margins were 68.7% for the quarter and were 71.3% on a non-GAAP adjusted basis.

    Net loss was $(27.4) million, or $(0.71) per share, compared to net loss of $(28.9) million, or $(0.77) per share in the prior year period. Non-GAAP adjusted EBITDA was $19.2 million, or 9.8% of net sales, compared to non-GAAP adjusted EBITDA of $13.5 million, or 7.3% of net sales, in the prior year period.

    Liquidity

    Cash, cash equivalents, and restricted cash on September 30, 2024, totaled $32.6 million compared to $28.9 million on June 30, 2024.

    Orthofix Announces New Three-Year Financial Targets

    The Company is providing new three-year financial targets for 2025 through 2027:

    • 6% to 7% net sales CAGR from 2025 through 2027
    • Mid-teens non-GAAP adjusted EBITDA as a percent of net sales for the full-year 2027
    • Positive free cash flow generation from 2025 through 2027

    Calafiore concluded, "With a compelling combination of profitable, above-market growth and a stronger financial profile, I believe our focused commercial strategy and broad, differentiated technologies, combined with a robust innovation pipeline and our pace-setting, enabling technologies position us well to achieve these targets and deliver increased value to our shareholders."

    Business Outlook

    The Company is reiterating its 2024 full-year guidance as follows:

    • Net sales are expected to range between $795 million to $800 million, representing implied growth of 6.6% to 7.2% year-over year on a constant currency basis. These expectations are based on the current foreign currency exchange rates and do not take into account any additional potential exchange rate changes that may occur this year.
    • Non-GAAP adjusted EBITDA is expected to range from $64 million to $69 million.
    • The Company expects to continue to be free cash flow positive for the remainder of 2024.

    These guidance ranges do not contemplate any potential impact to elective procedures as a result of IV fluid shortages or other hurricane-related effects.

    An investor presentation for the Company's third quarter 2024 financial results, corporate strategy and new three-year financial targets is available in the "Investors" section of Orthofix's website at https://ir.orthofix.com/events-and-presentations.

    Conference Call

    Orthofix will host a conference call today at 8:30 AM Eastern time to discuss the Company's financial results for the quarter ended September 30, 2024. Interested parties may access the conference call by dialing (888) 330-2508 in the U.S., 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 (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.

    About Orthofix

    Orthofix is a global medical technology company headquartered in Lewisville, Texas. By providing medical technologies that heal musculoskeletal pathologies, we deliver exceptional experiences and life-changing solutions to patients around the world. Orthofix offers a comprehensive portfolio of spinal hardware, bone growth therapies, specialized orthopedic solutions, biologics and enabling technologies, including the 7D FLASH™ navigation system. To learn more, visit Orthofix.com and follow on LinkedIn.

    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, intentions, plans, 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. Forward-looking statements in this communication include the Company's expectations regarding net sales, adjusted EBITDA, and free cash flow for the year ended December 31, 2024, and its three-year financial targets for 2025 through 2027. Forward-looking statements are not guarantees of our future performance, are based on our current expectations and assumptions regarding our business, the economy and other future conditions, and are subject to risks, uncertainties and changes in circumstances 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, 2023 (the "2023 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, 2024. Factors that could cause future results to differ from those expressed by forward-looking statements include, but are not limited to, (i) our ability to maintain operations to support our customers and patients in the near-term and to capitalize on future growth opportunities, (ii) risks associated with acceptance of surgical products and procedures by surgeons and hospitals, (iii) development and acceptance of new products or product enhancements, (iv) clinical and statistical verification of the benefits achieved via the use of our products, (v) our ability to adequately manage inventory, (vi) our ability to recruit and retain management and key personnel, (vii) our success in defending legal proceedings brought against us, and (viii) the other risks and uncertainties more fully described in our periodic filings with the Securities and Exchange Commission (the "SEC"). As a result of these various risks, our actual outcomes and results may differ materially from those expressed in 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, except as required by law.

    The Company is unable to provide expectations of GAAP income (loss) before income taxes, the closest comparable GAAP measures to adjusted EBITDA (which is a non-GAAP measure), on a forward-looking basis because the Company is unable to predict, without unreasonable efforts, the ultimate outcome of matters (including acquisition-related expenses, accounting fair value adjustments, and other such items) that will determine the quantitative amount of the items excluded in calculating adjusted EBITDA, 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 GAAP.

    ORTHOFIX MEDICAL INC.

    Condensed Consolidated Statements of Operations

     

     

     

    Three Months Ended

     

     

    Nine Months Ended

     

     

     

    September 30,

     

     

    September 30,

     

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

     

    2024

     

     

    2023

     

     

    2024

     

     

    2023

     

     

     

     

     

     

     

     

     

     

     

    Net sales

     

    $

    196,606

     

     

    $

    184,006

     

     

    $

    583,834

     

     

    $

    546,226

     

    Cost of sales

     

     

    61,553

     

     

     

    64,243

     

     

     

    186,790

     

     

     

    196,583

     

    Gross profit

     

     

    135,053

     

     

     

    119,763

     

     

     

    397,044

     

     

     

    349,643

     

    Sales and marketing

     

     

    96,576

     

     

     

    94,947

     

     

     

    296,843

     

     

     

    287,987

     

    General and administrative

     

     

    33,561

     

     

     

    27,136

     

     

     

    99,203

     

     

     

    110,124

     

    Research and development

     

     

    17,294

     

     

     

    18,559

     

     

     

    54,835

     

     

     

    61,290

     

    Acquisition-related amortization and remeasurement

     

     

    6,521

     

     

     

    3,570

     

     

     

    19,305

     

     

     

    11,037

     

    Operating loss

     

     

    (18,899

    )

     

     

    (24,449

    )

     

     

    (73,142

    )

     

     

    (120,795

    )

    Interest expense, net

     

     

    (5,210

    )

     

     

    (1,576

    )

     

     

    (14,711

    )

     

     

    (4,131

    )

    Other expense, net

     

     

    (2,528

    )

     

     

    (2,360

    )

     

     

    (6,312

    )

     

     

    (1,704

    )

    Loss before income taxes

     

     

    (26,637

    )

     

     

    (28,385

    )

     

     

    (94,165

    )

     

     

    (126,630

    )

    Income tax expense

     

     

    (751

    )

     

     

    (472

    )

     

     

    (2,686

    )

     

     

    (2,591

    )

    Net loss

     

    $

    (27,388

    )

     

    $

    (28,857

    )

     

    $

    (96,851

    )

     

    $

    (129,221

    )

     

     

     

     

     

     

     

     

     

     

     

     

     

    Net loss per common share:

     

     

     

     

     

     

     

     

     

     

     

     

    Basic

     

    $

    (0.71

    )

     

    $

    (0.77

    )

     

    $

    (2.55

    )

     

    $

    (3.53

    )

    Diluted

     

     

    (0.71

    )

     

     

    (0.77

    )

     

     

    (2.55

    )

     

     

    (3.53

    )

    Weighted average number of common shares (in millions):

     

     

     

     

     

     

     

     

     

     

     

     

    Basic

     

     

    38.5

     

     

     

    37.2

     

     

     

    37.9

     

     

     

    36.6

     

    Diluted

     

     

    38.5

     

     

     

    37.2

     

     

     

    37.9

     

     

     

    36.6

     

    ORTHOFIX MEDICAL INC.

    Condensed Consolidated Balance Sheets

     

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

     

    September 30,

    2024

     

     

    December 31,

    2023

     

     

     

    (Unaudited)

     

     

     

     

    Assets

     

     

     

     

     

     

    Current assets

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    30,054

     

     

    $

    33,107

     

    Restricted Cash

     

     

    2,500

     

     

     

    4,650

     

    Accounts receivable, net of allowances of $7,878 and $7,130, respectively

     

     

    124,845

     

     

     

    128,098

     

    Inventories

     

     

    205,812

     

     

     

    222,166

     

    Prepaid expenses and other current assets

     

     

    23,003

     

     

     

    32,422

     

    Total current assets

     

     

    386,214

     

     

     

    420,443

     

    Property, plant, and equipment, net

     

     

    146,685

     

     

     

    159,060

     

    Intangible assets, net

     

     

    104,546

     

     

     

    117,490

     

    Goodwill

     

     

    194,934

     

     

     

    194,934

     

    Other long-term assets

     

     

    35,493

     

     

     

    33,388

     

    Total assets

     

    $

    867,872

     

     

    $

    925,315

     

    Liabilities and shareholders' equity

     

     

     

     

     

     

    Current liabilities

     

     

     

     

     

     

    Accounts payable

     

    $

    47,060

     

     

    $

    58,357

     

    Current portion of long-term debt

     

     

    6,250

     

     

     

    1,250

     

    Current portion of finance lease liability

     

     

    743

     

     

     

    708

     

    Other current liabilities

     

     

    107,845

     

     

     

    104,908

     

    Total current liabilities

     

     

    161,898

     

     

     

    165,223

     

    Long-term debt

     

     

    112,215

     

     

     

    93,107

     

    Long-term portion of finance lease liability

     

     

    18,027

     

     

     

    18,532

     

    Other long-term liabilities

     

     

    49,808

     

     

     

    49,723

     

    Total liabilities

     

     

    341,948

     

     

     

    326,585

     

    Contingencies

     

     

     

     

     

     

    Shareholders' equity

     

     

     

     

     

     

    Common shares $0.10 par value; 100,000 shares authorized;

    38,209 and 37,165 issued and outstanding as of September 30,

    2024, and December 31, 2023, respectively

     

     

    3,821

     

     

     

    3,717

     

    Additional paid-in capital

     

     

    770,000

     

     

     

    746,450

     

    Accumulated deficit

     

     

    (246,995

    )

     

     

    (150,144

    )

    Accumulated other comprehensive loss

     

     

    (902

    )

     

     

    (1,293

    )

    Total shareholders' equity

     

     

    525,924

     

     

     

    598,730

     

    Total liabilities and shareholders' equity

     

    $

    867,872

     

     

    $

    925,315

     

    ORTHOFIX MEDICAL INC.

    Non-GAAP Financial Measures

    The following tables present reconciliations of various financial measures calculated in accordance with U.S. generally accepted accounting principles ("GAAP"), to various non-GAAP financial measures that exclude (or in the case of free cash flow, include) 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. For further information regarding the nature of these exclusions, why the Company believes that these non-GAAP financial measures provide useful information to investors, the specific manner in which management uses these measures, and some of the limitations associated with the use of these measures, please refer to the Company's Current Report on Form 8-K regarding this press release filed today with the SEC available on the SEC's website at www.sec.gov and on the "Investors" page of the Company's website at www.orthofix.com.

    Adjusted Gross Profit and Adjusted Gross Margin

     

     

    Three Months Ended September 30,

     

     

    Nine Months Ended September 30,

     

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

     

    2024

     

     

    2023

     

     

    2024

     

     

    2023

     

    Gross profit

     

    $

    135,053

     

     

    $

    119,763

     

     

    $

    397,044

     

     

    $

    349,643

     

    Share-based compensation expense

     

     

    557

     

     

     

    463

     

     

     

    1,591

     

     

     

    1,416

     

    SeaSpine merger-related costs

     

     

    1,161

     

     

     

    2,161

     

     

     

    5,579

     

     

     

    6,647

     

    Strategic investments

     

     

    32

     

     

     

    55

     

     

     

    160

     

     

     

    264

     

    Acquisition-related fair value adjustments

     

     

    3,047

     

     

     

    7,922

     

     

     

    9,141

     

     

     

    29,007

     

    Amortization/depreciation of acquired long-lived assets

     

     

    313

     

     

     

    280

     

     

     

    840

     

     

     

    824

     

    Medical device regulation

     

     

    —

     

     

     

    6

     

     

     

    —

     

     

     

    676

     

    Adjusted gross profit

     

    $

    140,163

     

     

    $

    130,650

     

     

    $

    414,355

     

     

    $

    388,477

     

    Adjusted gross margin

     

     

    71.3

    %

     

     

    71.0

    %

     

     

    71.0

    %

     

     

    71.1

    %

    Adjusted EBITDA

     

     

    Three Months Ended September 30,

     

     

    Nine Months Ended September 30,

     

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

     

    2024

     

     

    2023

     

     

    2024

     

     

    2023

     

    Net loss

     

    $

    (27,388

    )

     

    $

    (28,857

    )

     

    $

    (96,851

    )

     

    $

    (129,221

    )

    Income tax expense (benefit)

     

     

    751

     

     

     

    472

     

     

     

    2,686

     

     

     

    2,591

     

    Interest expense, net

     

     

    5,210

     

     

     

    1,576

     

     

     

    14,711

     

     

     

    4,131

     

    Depreciation and amortization

     

     

    15,173

     

     

     

    13,097

     

     

     

    44,067

     

     

     

    39,094

     

    Share-based compensation expense

     

     

    6,531

     

     

     

    6,274

     

     

     

    25,290

     

     

     

    32,540

     

    Foreign exchange impact

     

     

    (1,176

    )

     

     

    1,909

     

     

     

    1,263

     

     

     

    1,057

     

    SeaSpine merger-related costs

     

     

    2,616

     

     

     

    5,416

     

     

     

    12,992

     

     

     

    34,362

     

    Strategic investments

     

     

    39

     

     

     

    484

     

     

     

    470

     

     

     

    1,454

     

    Acquisition-related fair value adjustments

     

     

    5,017

     

     

     

    7,122

     

     

     

    15,351

     

     

     

    26,907

     

    Interest and loss on investments

     

     

    3,567

     

     

     

    429

     

     

     

    5,120

     

     

     

    429

     

    Litigation and investigation costs

     

     

    8,335

     

     

     

    3,851

     

     

     

    10,318

     

     

     

    5,611

     

    Succession charges

     

     

    505

     

     

     

    (92

    )

     

     

    8,061

     

     

     

    170

     

    Medical device regulation

     

     

    —

     

     

     

    1,840

     

     

     

    —

     

     

     

    7,519

     

    Adjusted EBITDA

     

    $

    19,180

     

     

    $

    13,521

     

     

    $

    43,478

     

     

    $

    26,644

     

    Adjusted EBITDA as a percentage of net sales

     

     

    9.8

    %

     

     

    7.3

    %

     

     

    7.4

    %

     

     

    4.9

    %

    Adjusted Net Income

     

     

    Three Months Ended

    September 30,

     

     

    Nine Months Ended

    September 30,

     

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

     

    2024

     

     

    2023

     

     

    2024

     

     

    2023

     

    Net loss

     

    $

    (27,388

    )

     

    $

    (28,857

    )

     

    $

    (96,851

    )

     

    $

    (129,221

    )

    Share-based compensation expense

     

     

    6,531

     

     

     

    6,274

     

     

     

    25,290

     

     

     

    32,540

     

    Foreign exchange impact

     

     

    (1,176

    )

     

     

    1,909

     

     

     

    1,263

     

     

     

    1,057

     

    SeaSpine merger-related costs

     

     

    2,619

     

     

     

    5,247

     

     

     

    13,434

     

     

     

    35,600

     

    Strategic investments

     

     

    69

     

     

     

    525

     

     

     

    566

     

     

     

    1,631

     

    Acquisition-related fair value adjustments

     

     

    5,017

     

     

     

    7,122

     

     

     

    15,351

     

     

     

    26,907

     

    Amortization/depreciation of acquired long-lived assets

     

     

    5,046

     

     

     

    5,026

     

     

     

    14,486

     

     

     

    14,970

     

    Litigation and investigation costs

     

     

    8,335

     

     

     

    3,851

     

     

     

    10,318

     

     

     

    5,611

     

    Succession charges

     

     

    505

     

     

     

    (94

    )

     

     

    8,061

     

     

     

    168

     

    Medical device regulation

     

     

    —

     

     

     

    1,842

     

     

     

    —

     

     

     

    7,531

     

    Interest and loss on investments

     

     

    3,567

     

     

     

    399

     

     

     

    5,071

     

     

     

    339

     

    Long-term income tax rate adjustment

     

     

    (335

    )

     

     

    (569

    )

     

     

    2,777

     

     

     

    2,669

     

    Adjusted net income (loss)

     

    $

    2,790

     

     

    $

    2,675

     

     

    $

    (234

    )

     

    $

    (198

    )

    Cash Flow and Free Cash Flow

     

     

    Nine Months Ended September 30,

     

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

     

    2024

     

     

    2023

     

    Net cash from operating activities

     

    $

    2,060

     

     

    $

    (39,059

    )

    Net cash from investing activities

     

     

    (26,445

    )

     

     

    (18,078

    )

    Net cash from financing activities

     

     

    19,222

     

     

     

    40,042

     

    Effect of exchange rate changes on cash

     

     

    (40

    )

     

     

    58

     

    Net change in cash and cash equivalents

     

    $

    (5,203

    )

     

    $

    (17,037

    )

     

     

    Nine Months Ended September 30,

     

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

     

    2024

     

     

    2023

     

    Net cash from operating activities

     

    $

    2,060

     

     

    $

    (39,059

    )

    Capital expenditures

     

     

    (26,345

    )

     

     

    (46,997

    )

    Free cash flow

     

    $

    (24,285

    )

     

    $

    (86,056

    )

    Reconciliation of Non-GAAP Financial Measures to Reported Operating Expenses

     

     

    Three Months Ended September 30,

     

     

    Nine Months Ended September 30,

     

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

     

    2024

     

     

    2023

     

     

    2024

     

     

    2023

     

    Sales and marketing expense, as reported

     

    $

    96,576

     

     

    $

    94,947

     

     

    $

    296,843

     

     

    $

    287,987

     

    Reconciling items impacting sales and marketing:

     

     

     

     

     

     

     

     

     

     

     

     

    Strategic investments

     

     

    65

     

     

     

    (1,680

    )

     

     

    (3,347

    )

     

     

    (5,201

    )

    Litigation and investigation costs

     

     

    377

     

     

     

    —

     

     

     

    377

     

     

     

    (857

    )

    Medical device regulation

     

     

    —

     

     

     

    (6

    )

     

     

    —

     

     

     

    (11

    )

    Amortization/depreciation of acquired long-lived assets

     

     

    (178

    )

     

     

    (178

    )

     

     

    (475

    )

     

     

    (475

    )

    Sales and marketing expense, as adjusted

     

    $

    96,840

     

     

    $

    93,083

     

     

    $

    293,398

     

     

    $

    281,443

     

    Sales and marketing expense as a percentage of net sales, as adjusted

     

     

    49.3

    %

     

     

    50.6

    %

     

     

    50.3

    %

     

     

    51.5

    %

     

     

    Three Months Ended September 30,

     

     

    Nine Months Ended September 30,

     

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

     

    2024

     

     

    2023

     

     

    2024

     

     

    2023

     

    General and administrative expense, as reported

     

    $

    33,561

     

     

    $

    27,136

     

     

    $

    99,203

     

     

    $

    110,124

     

    Reconciling items impacting general and administrative:

     

     

     

     

     

     

     

     

     

     

     

     

    Strategic investments

     

     

    (1,420

    )

     

     

    (1,522

    )

     

     

    (4,254

    )

     

     

    (21,514

    )

    Amortization/depreciation of acquired long-lived assets

     

     

    (4

    )

     

     

    (201

    )

     

     

    (76

    )

     

     

    (537

    )

    Litigation and investigation costs

     

     

    (8,712

    )

     

     

    (3,852

    )

     

     

    (10,695

    )

     

     

    (4,754

    )

    Succession charges

     

     

    (505

    )

     

     

    93

     

     

     

    (8,061

    )

     

     

    (169

    )

    General and administrative expense, as adjusted

     

    $

    22,920

     

     

    $

    21,654

     

     

    $

    76,117

     

     

    $

    83,150

     

    General and administrative expense as a percentage of net sales, as adjusted

     

     

    11.7

    %

     

     

    11.8

    %

     

     

    13.0

    %

     

     

    15.2

    %

     

     

    Three Months Ended September 30,

     

     

    Nine Months Ended September 30,

     

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

     

    2024

     

     

    2023

     

     

    2024

     

     

    2023

     

    Research and development expense, as reported

     

    $

    17,294

     

     

    $

    18,559

     

     

    $

    54,835

     

     

    $

    61,290

     

    Reconciling items impacting research and development:

     

     

     

     

     

     

     

     

     

     

     

     

    Strategic investments

     

     

    (69

    )

     

     

    (356

    )

     

     

    (645

    )

     

     

    (2,730

    )

    Medical device regulation

     

     

    —

     

     

     

    (1,837

    )

     

     

    —

     

     

     

    (6,854

    )

    Research and development expense, as adjusted

     

    $

    17,225

     

     

    $

    16,366

     

     

    $

    54,190

     

     

    $

    51,706

     

    Research and development expense as a percentage of net sales, as adjusted

     

     

    8.8

    %

     

     

    8.9

    %

     

     

    9.3

    %

     

     

    9.5

    %

    Reconciliation of Non-GAAP Financial Measures to Reported Non-Operating (Income) Expense

     

     

    Three Months Ended September 30,

     

     

    Nine Months Ended September 30,

     

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

     

    2024

     

     

    2023

     

     

    2024

     

     

    2023

     

    Non-operating expense

     

    $

    7,738

     

     

    $

    3,936

     

     

    $

    21,023

     

     

    $

    5,835

     

    Reconciling items impacting non-operating expense:

     

     

     

     

     

     

     

     

     

     

     

     

    Foreign exchange impact

     

     

    1,176

     

     

     

    (1,909

    )

     

     

    (1,263

    )

     

     

    (1,057

    )

    Strategic investments

     

     

    —

     

     

     

    —

     

     

     

    —

     

     

     

    (895

    )

    Interest and loss on investments

     

     

    (3,566

    )

     

     

    (399

    )

     

     

    (5,070

    )

     

     

    (339

    )

    Non-operating expense, as adjusted

     

    $

    5,348

     

     

    $

    1,628

     

     

    $

    14,690

     

     

    $

    3,544

     

    Non-operating expense as a percentage of net sales, as adjusted

     

     

    2.7

    %

     

     

    0.9

    %

     

     

    2.5

    %

     

     

    0.6

    %

     

    View source version on businesswire.com: https://www.businesswire.com/news/home/20241107805269/en/

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