Orthofix Medical Inc 10-Q for FY2024 Q2
Orthofix Medical Inc. (OFIX)
About this 10-Q
Orthofix Medical Inc filed this 10-Q on August 6, 2024, covering the quarter ended June 30, 2024 (FY2024 Q2).
Headline figures
Quarter ended June 30, 2024, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $198.62M
- up 6.2% from $187.02M a year earlier
- Net loss
- $33.44M
- compared with a net loss of $39.43M a year earlier
- Diluted EPS
- -$0.88
- compared with -$1.07 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
(Mark one)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to .
Commission File Number:
(Exact name of registrant as specified in its charter)
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(Former name, former address and former fiscal year, if changed since last report)
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☒
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☒
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large Accelerated filer |
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Smaller Reporting Company |
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Emerging Growth Company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes
As of August 2, 2024,
Securities registered pursuant to Section 12(b) of the Act:
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Table of Contents
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PART I |
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Item 1. |
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4 |
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Condensed Consolidated Balance Sheets as of June 30, 2024, and December 31, 2023 |
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4 |
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5 |
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Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2024, and 2023 |
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Notes to the Unaudited Condensed Consolidated Financial Statements |
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Item 2. |
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Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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Item 3. |
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32 |
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Item 4. |
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32 |
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PART II |
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Item 1. |
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34 |
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Item 1A. |
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34 |
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Item 2. |
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34 |
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Item 3. |
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34 |
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Item 4. |
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34 |
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Item 5. |
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34 |
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Item 6. |
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34 |
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38 |
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2
Forward-Looking Statements
This Quarterly Report 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. All statements, other than statements of historical fact, contained in this report, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “intends,” “predicts,” “potential,” or “continue” or the negative version of those terms and other similar expressions. Forward-looking statements include, but are not limited to, statements about:
Forward-looking statements are not guarantees of future performance and involve risks, uncertainties, estimates, and assumptions. 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 forward-looking statements. Potential risks and uncertainties that could cause actual results to differ materially include, but are not limited to, those set forth in Part I, Item 1A under the heading Risk Factors of our Annual Report on Form 10-K for the year ended December 31, 2023 ("2023 10-K"); Part II, Item 7 Management’s Discussion and Analysis of Financial Condition and Results of Operations of the 2023 10-K; and elsewhere throughout the 2023 10-K, and in our reports filed with the U.S. Securities and Exchange Commission (the "SEC") subsequent to the date we filed the 2023 10-K with the SEC. You should not place undue reliance on any forward-looking statements. Further, any forward-looking statement in this report speaks only as of the date hereof, unless it is specifically otherwise stated to be made as of a different date. Except as required by law, 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.
Trademarks
Solely for convenience, our trademarks and trade names in this report are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that we will not assert, to the fullest extent under applicable law, our rights thereto.
3
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
ORTHOFIX MEDICAL INC.
Condensed Consolidated Balance Sheets
(U.S. Dollars, in thousands, except par value data) |
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June 30, |
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December 31, |
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(Unaudited) |
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Assets |
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Current assets |
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Cash and cash equivalents |
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$ |
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$ |
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Restricted cash |
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Accounts receivable, net of allowances of $ |
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Inventories |
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Prepaid expenses and other current assets |
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Total current assets |
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Property, plant, and equipment, net |
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Intangible assets, net |
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Goodwill |
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Other long-term assets |
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Total assets |
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$ |
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$ |
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Liabilities and shareholders’ equity |
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Current liabilities |
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Accounts payable |
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$ |
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$ |
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Current portion of long-term debt |
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Current portion of finance lease liability |
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Other current liabilities |
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Total current liabilities |
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Long-term debt |
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Long-term portion of finance lease liability |
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Other long-term liabilities |
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Total liabilities |
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Shareholders’ equity |
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Common shares $ |
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Additional paid-in capital |
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Accumulated deficit |
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Accumulated other comprehensive loss |
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Total shareholders’ equity |
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Total liabilities and shareholders’ equity |
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$ |
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$ |
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The accompanying notes form an integral part of these condensed consolidated financial statements
4
ORTHOFIX MEDICAL INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
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Three Months Ended |
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Six Months Ended |
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(Unaudited, U.S. Dollars, in thousands, except per share data) |
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2024 |
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2023 |
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2024 |
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2023 |
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Net sales |
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$ |
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$ |
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$ |
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$ |
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Cost of sales |
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Gross profit |
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Sales and marketing |
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General and administrative |
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Research and development |
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Acquisition-related amortization and remeasurement (Note 12) |
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Operating loss |
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Interest expense, net |
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Other income (expense), net |
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( |
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( |
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Loss before income taxes |
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Income tax expense |
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Net loss |
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$ |
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$ |
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$ |
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$ |
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Net loss per common share: |
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Basic |
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$ |
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$ |
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$ |
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$ |
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Diluted |
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Weighted average number of common shares: |
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Basic |
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Diluted |
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Other comprehensive income (loss), before tax |
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Unrealized gain (loss) on debt securities |
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— |
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Reclassification adjustment for historical unrealized gain on debt security |
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— |
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Currency translation adjustment |
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Other comprehensive income (loss), before tax |
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Income tax benefit (expense) related to other comprehensive income |
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— |
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— |
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— |
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Other comprehensive income (loss), net of tax |
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( |
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Comprehensive loss |
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$ |
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$ |
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$ |
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$ |
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The accompanying notes form an integral part of these condensed consolidated financial statements
5
ORTHOFIX MEDICAL INC.
(Unaudited, U.S. Dollars, in thousands) |
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Number of |
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Common |
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Additional |
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Accumulated Deficit |
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Accumulated |
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Total |
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At December 31, 2023 |
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$ |
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$ |
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$ |
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$ |
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$ |
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Net loss |
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— |
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— |
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— |
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( |
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— |
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Other comprehensive income, net of tax |
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— |
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— |
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— |
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— |
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Share-based compensation expense |
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— |
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— |
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— |
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— |
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Common shares issued, net |
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( |
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— |
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— |
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At March 31, 2024 |
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$ |
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$ |
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$ |
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$ |
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$ |
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Net loss |
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— |
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— |
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— |
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( |
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— |
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Other comprehensive loss, net of tax |
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— |
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— |
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— |
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— |
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( |
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Share-based compensation expense |
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— |
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— |
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— |
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— |
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Common shares issued, net |
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— |
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— |
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At June 30, 2024 |
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$ |
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$ |
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$ |
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$ |
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$ |
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(Unaudited, U.S. Dollars, in thousands) |
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Number of |
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Common |
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Additional |
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Retained |
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Accumulated |
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Total |
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At December 31, 2022 |
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$ |
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$ |
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$ |
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$ |
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Net loss |
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— |
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— |
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— |
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( |
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— |
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( |
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Other comprehensive income, net of tax |
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— |
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— |
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— |
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— |
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Share-based compensation expense |
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— |
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— |
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— |
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— |
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Common shares issued in connection with SeaSpine merger |
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— |
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— |
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Common shares issued, net |
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( |
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— |
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— |
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At March 31, 2023 |
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$ |
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$ |
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$ |
( |
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$ |
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$ |
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Net loss |
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— |
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— |
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— |
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( |
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— |
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Other comprehensive income, net of tax |
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— |
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— |
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— |
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— |
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Share-based compensation expense |
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— |
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— |
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— |
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— |
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Common shares issued, net |
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— |
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— |
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At June 30, 2023 |
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$ |
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$ |
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$ |
( |
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$ |
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$ |
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The accompanying notes form an integral part of these condensed consolidated financial statements
6
ORTHOFIX MEDICAL INC.
Condensed Consolidated Statements of Cash Flows
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Six Months Ended |
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(Unaudited, U.S. Dollars, in thousands) |
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2024 |
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2023 |
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Cash flows from operating activities |
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Net loss |
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$ |
( |
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$ |
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Adjustments to reconcile net loss to net cash from operating activities |
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Depreciation and amortization |
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Inventory reserve expenses |
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Amortization of inventory fair value step up |
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Amortization of operating lease assets, debt costs, and other assets |
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Provision for expected credit losses |
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Deferred income taxes |
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Share-based compensation expense |
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Change in valuation of investment securities |
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Change in fair value of contingent consideration |
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Other |
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Changes in operating assets and liabilities, net of effects of acquisitions |
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Accounts receivable |
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Inventories |
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( |
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Prepaid expenses and other current assets |
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Accounts payable |
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( |
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Other current liabilities |
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( |
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( |
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Other long-term assets and liabilities |
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( |
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( |
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Net cash used in operating activities |
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( |
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Cash flows from investing activities |
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Capital expenditures for property, plant, and equipment |
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( |
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( |
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Capital expenditures for intangible assets |
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Cash acquired in the SeaSpine merger |
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— |
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Other investing activities |
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( |
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( |
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Net cash provided by (used in) investing activities |
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( |
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Cash flows from financing activities |
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Proceeds from issuance of common shares |
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Payments related to tax withholdings for share-based compensation |
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( |
) |
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|
( |
) |
Payments related to finance lease obligation |
|
|
( |
) |
|
|
( |
) |
Borrowings under credit facility |
|
|
|
|
|
|
||
Repayment of borrowings from credit facility |
|
|
( |
) |
|
|
— |
|
Payment of debt acquired from SeaSpine merger |
|
|
— |
|
|
|
( |
) |
Contingent consideration milestone payment |
|
|
— |
|
|
|
( |
) |
Payment of debt issuance costs and other financing activities |
|
|
( |
) |
|
|
( |
) |
Net cash provided by financing activities |
|
|
|
|
|
|
||
Effect of exchange rate changes on cash |
|
|
( |
) |
|
|
|
|
Net change in cash and cash equivalents |
|
|
( |
) |
|
|
( |
) |
Cash, cash equivalents, and restricted cash at the beginning of period |
|
|
|
|
|
|
||
Cash, cash equivalents, and restricted cash at the end of period |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
Components of cash, cash equivalents, and restricted cash at the end of period |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
|
|
$ |
|
||
Restricted cash |
|
|
|
|
|
— |
|
|
Cash, cash equivalents, and restricted cash at the end of period |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
Noncash investing activities - Purchase of intangible assets |
|
$ |
|
|
$ |
— |
|
|
The accompanying notes form an integral part of these condensed consolidated financial statements
7
ORTHOFIX MEDICAL INC.
Notes to the Unaudited Condensed Consolidated Financial Statements
1. Business and basis of presentation
Description of the Business
Orthofix Medical Inc. (the “Company” or "Orthofix") is a leading global spine and orthopedics company with a comprehensive portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions, and a leading surgical navigation system. Its products are distributed in more than 60 countries worldwide.
The Company is headquartered in Lewisville, Texas, where it conducts general business, product development, medical education and manufacturing, and has primary offices in Carlsbad, CA, with a focus on spine and biologics product innovation and surgeon education, and Verona, Italy, with an emphasis on product innovation, production, and medical education for orthopedics. The combined company’s global research and development, commercial, and manufacturing footprint also includes facilities and offices in Irvine, CA, Toronto, Canada, Sunnyvale, CA, Maidenhead, UK, Munich, Germany, Paris, France, and São Paulo, Brazil.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. Pursuant to these rules and regulations, certain information and note disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. In the opinion of management, all adjustments (consisting of normal recurring items) considered necessary for a fair statement have been included. These condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and related notes contained in the Company’s Form 10-K for the year ended December 31, 2023. Operating results for the three and six months ended June 30, 2024, are not necessarily indicative of the results that may be expected for other interim periods or the year ending December 31, 2024.
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, the Company evaluates its estimates, including those related to revenue recognition; contractual allowances; allowances for expected credit losses; inventories; valuation of intangible assets; goodwill; fair value measurements, including contingent consideration; litigation and contingent liabilities; tax matters; and share-based compensation. Actual results could differ from these estimates.
2. Recently adopted accounting standards, recently issued accounting pronouncements
Adoption of Accounting Standards Update ("ASU") 2022-03 - Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions
In June 2022, the Financial Accounting Standards Board ("FASB") issued ASU 2022-03, which clarifies the guidance in Topic 820, Fair Value Measurement, when measuring the fair value of an equity security subject to contractual restrictions that prohibit the sale and to introduce new disclosure requirements. The Company adopted this standard effective January 1, 2024, on a prospective basis. Adoption of this standard did not have a material impact to the Company's consolidated balance sheet, statements of operations, or cash flows, but did modify the Company's disclosures related to certain investments. Refer to Note 7 for the Company's updated disclosures on investments in equity securities subject to capital sale restrictions.
Adoption of ASU 2023-07 - Improvements to Reportable Segment Disclosures
In November 2023, the FASB issued ASU 2023-07, which enhances and improves disclosures about operating segment's revenues, measures of profit/loss, and expenses to enable investors to better understand an entity's overall performance and assess potential future cash flows. The amendment requires that an entity disclose (i) significant expenses that are regularly provided to the Chief Operating Decision Maker ("CODM"), (ii) other segment items by reportable segment including a description of its composition, (iii) all annual disclosures required by Topic 280 in interim periods, (iv) additional measures of a segment's profit or loss used by the CODM in assessing segment performance and allocation of resources, and (v) title and position of the CODM and an explanation of how the CODM uses the reported measure(s) of segment profit or loss. The Company adopted this standard effective January 1, 2024, on a prospective basis. Refer to Note 11 for the Company's updated business segment disclosures.
8
Recently Issued Accounting Pronouncements
Topic |
|
Description of Guidance |
|
Effective Date |
|
Status of Company's Evaluation |
Disclosure Improvements - Codification Amendments in Response to the SEC's Disclosure Update and Simplification Initiative (ASU 2023-06) |
|
Adds interim and annual disclosure requirements to a variety of subtopics in the Accounting Standards Codification, including those focusing on accounting changes, earnings per share, debt and repurchase agreements. The guidance will be applied prospectively. The effective date will be the date when the SEC's removal of the related disclosure requirement becomes effective, with early adoption prohibited. |
|
Various |
|
The Company is currently evaluating the impact this ASU may have on its consolidated financial statements. |
Improvements to Income Tax Disclosures (ASU 2023-09) |
|
Enhance the transparency and decision usefulness of income tax disclosures to better assess how an entity’s operations and related tax risks and tax planning and operational opportunities affect its tax rate and |
|
January 1, 2025 |
|
The Company is currently evaluating the impact this ASU may have on its consolidated financial statements. |
Other recently issued ASUs, excluding those ASUs which have already been disclosed as adopted or described above, were assessed and determined not applicable, or are expected to have minimal impact on the Company's condensed consolidated financial statements.
3. Mergers and acquisitions
Merger with SeaSpine
On January 5, 2023, the Company and SeaSpine completed an all-stock merger of equals (the "Merger") to create a leading global spine and orthopedics company with highly complementary portfolios of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions, and a leading surgical navigation system. As a result of the Merger, each share of SeaSpine common stock issued and outstanding immediately prior to the closing of the Merger was converted into the right to receive
9
During the fourth quarter of 2023, the Company finalized its valuation of assets acquired and liabilities assumed.
(U.S. Dollars, in thousands) |
|
Final Acquisition Date Fair Value |
|
|
Assigned Useful Life |
|
Assets acquired: |
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
|
|
|
|
Accounts receivable, net |
|
|
|
|
|
|
Inventories |
|
|
|
|
|
|
Prepaid expenses and other current assets |
|
|
|
|
|
|
Total current assets |
|
|
|
|
|
|
Property, plant, and equipment, net |
|
|
|
|
|
|
Customer relationships |
|
|
|
|
||
Developed technology |
|
|
|
|
||
In-process research and development ("IPR&D") |
|
|
|
|
||
Other long-term assets |
|
|
|
|
|
|
Total identifiable assets acquired |
|
$ |
|
|
|
|
|
|
|
|
|
|
|
Liabilities assumed: |
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
Accounts payable |
|
$ |
|
|
|
|
Other current liabilities |
|
|
|
|
|
|
Total current liabilities |
|
|
|
|
|
|
Long-term borrowings under SeaSpine credit facility |
|
|
|
|
|
|
Other long-term liabilities |
|
|
|
|
|
|
Total liabilities assumed |
|
|
|
|
|
|
Net identifiable assets acquired |
|
$ |
|
|
|
|
Total fair value of consideration transferred |
|
|
|
|
|
|
Residual goodwill |
|
$ |
|
|
|
|
The Company recognized ($
Due to the completion of the Merger on January 5, 2023, all SeaSpine financial results for fiscal year 2023, except for the first four days of January, were included in the Company's condensed consolidated statement of operations and comprehensive loss. Therefore, the Company did not prepare unaudited pro forma financial information for the three and six months ended June 30, 2023 or 2024, on the basis that the Merger was completed on January 1, 2023.
10
4. Inventories
Inventories were as follows:
(U.S. Dollars, in thousands) |
|
June 30, |
|
|
December 31, |
|
||
|
|
(Unaudited) |
|
|
|
|
||
Raw materials |
|
$ |
|
|
$ |
|
||
Work-in-process |
|
|
|
|
|
|
||
Finished products |
|
|
|
|
|
|
||
Inventories |
|
$ |
|
|
$ |
|
||
5. Leases
A summary of the Company's lease portfolio as of June 30, 2024, and December 31, 2023, is presented in the table below:
(U.S. Dollars, in thousands) |
|
Classification |
|
June 30, |
|
|
December 31, |
|
||
|
|
|
|
(Unaudited) |
|
|
|
|
||
Right-of-use assets ("ROU assets") |
|
|
|
|
|
|
||||
Operating leases |
|
|
$ |
|
|
$ |
|
|||
Finance leases |
|
|
|
|
|
|
|
|||
Total ROU assets |
|
|
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
|
|
||
Lease Liabilities |
|
|
|
|
|
|
|
|
||
Current |
|
|
|
|
|
|
|
|
||
Operating leases |
|
|
$ |
|
|
$ |
|
|||
Finance leases |
|
Current portion of finance lease liability |
|
|
|
|
|
|
||
Long-term |
|
|
|
|
|
|
|
|
||
Operating leases |
|
|
|
|
|
|
|
|||
Finance leases |
|
Long-term portion of finance lease liability |
|
|
|
|
|
|
||
Total lease liabilities |
|
|
|
$ |
|
|
$ |
|
||
Supplemental cash flow information related to leases was as follows:
(Unaudited, U.S. Dollars, in thousands) |
|
Six Months Ended |
|
|
Six Months Ended |
|
||
Cash paid for amounts included in the measurement of lease liabilities |
|
|
|
|
|
|
||
Operating cash flows from operating leases |
|
$ |
|
|
$ |
|
||
Operating cash flows from finance leases |
|
|
|
|
|
|
||
Financing cash flows from finance leases |
|
|
|
|
|
|
||
ROU assets obtained in exchange for lease obligations |
|
|
|
|
|
|
||
Operating leases |
|
|
|
|
|
|
||
Finance leases |
|
|
— |
|
|
|
— |
|
11
6. Long-term debt
The carrying values of the Company's outstanding debt obligations as of June 30, 2024, and December 31, 2023, were as follows:
(U.S. Dollars, in thousands) |
|
June 30, |
|
|
December 31, |
|
||
|
|
(Unaudited) |
|
|
|
|
||
Initial Term Loan and Delayed Draw Term Loan |
|
|
|
|
|
|
||
Principal amount |
|
$ |
|
|
$ |
|
||
Unamortized original debt discount |
|
|
( |
) |
|
|
( |
) |
Unamortized debt issuance costs and lenders fees |
|
|
( |
) |
|
|
( |
) |
Total indebtedness from initial term loan and delayed draw term loan |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Revolving Credit Facilities |
|
|
|
|
|
|
||
Principal amount outstanding |
|
|
— |
|
|
|
— |
|
Total indebtedness outstanding |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
Current portion of long-term debt |
|
$ |
|
|
$ |
|
||
Long-term debt |
|
|
|
|
|
|
||
Total indebtedness outstanding |
|
$ |
|
|
$ |
|
||
On January 10, 2024, the Company borrowed $
The Financing Agreement contains financial covenants requiring the Company to maintain a minimum level of liquidity at all times, a maximum consolidated leverage ratio (measured on a quarterly basis), and a minimum asset coverage ratio (measured on a monthly basis). As of June 30, 2024, the Company was in compliance with all required financial covenants.
On March 15, 2024, the Company entered into Amendment No.1 to the Financing Agreement with Blue Torch Finance LLC (the "First Amendment"). Under the terms of the First Amendment, the parties agreed to reduce the number of business days to submit a notice of borrowing for the Delayed Draw Term Loan, and redefine certain terms within the asset coverage financial covenant. The maturity date remains November 6, 2027, for each of the Initial Term Loan, Delayed Draw Term Loan, and Revolving Credit Facility.
As of June 30, 2024, the Company had
7. Fair value measurements and investments
The fair value measurements of the Company’s financial assets and liabilities measured on a recurring basis were as follows:
|
|
June 30, |
|
|
December 31, |
|
||||||||||||||
(Unaudited, U.S. Dollars, in thousands) |
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
|
Total |
|
|||||
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Neo Medical convertible loan agreement |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
|
Neo Medical preferred equity securities |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
|||
Other investments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Total |
|
$ |
— |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|
$ |
|
|||
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Lattus contingent consideration |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Deferred compensation plan |
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Total |
|
$ |
— |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
12
Neo Medical Convertible Loan Agreement and Equity Investment
Since October 2020, the Company has held preferred equity securities of Neo Medical SA, a privately held Swiss-based company developing a new generation of products for spinal surgery ("Neo Medical") and a Convertible Loan Agreement, pursuant to which the Company loaned Neo Medical CHF
In April 2024, the Company converted the Convertible Loan into shares of Neo Medical preferred equity securities. The preferred equity securities are recorded in other long-term assets and are considered an investment that does not have a readily determinable fair value. As such, the Company measures this investment at cost, less any impairment, plus or minus changes resulting from observable price changes in orderly transactions for identical or similar investments of the same issuer.
The Company's equity investment with Neo Medical is subject to certain sales restrictions, such as right of first refusal, tag-along provisions, and drag-along provisions. Permitted transfers include (i) sales of shares to an affiliate of such shareholder, (ii) transfer of shares as part of a compensation package offered to employees, or (iii) Neo Medical may repurchase shares at a price no greater than that originally paid by the shareholder.
The table below presents a reconciliation of the beginning and ending balances of the Company’s investment in Neo Medical preferred equity securities:
(Unaudited, U.S. Dollars, in thousands) |
|
2024 |
|
|
2023 |
|
||
Fair value of Neo Medical preferred equity securities at January 1 |
|
$ |
|
|
$ |
|
||
Conversion of loan into preferred equity securities |
|
|
|
|
|
— |
|
|
Foreign currency remeasurement recognized in other income (expense), net |
|
|
— |
|
|
|
— |
|
Unrealized loss recognized in other expense, net |
|
|
( |
) |
|
|
— |
|
Fair value of Neo Medical preferred equity securities at June 30 |
|
$ |
|
|
$ |
|
||
Cumulative unrealized gain (loss) on Neo Medical preferred equity securities |
|
$ |
( |
) |
|
$ |
|
|
The following table provides a reconciliation of the beginning and ending balances of the Convertible Loan, which was measured at fair value using significant unobservable inputs:
(Unaudited, U.S. Dollars, in thousands) |
|
2024 |
|
|
2023 |
|
||
Fair value of Neo Medical Convertible Loan at January 1 |
|
$ |
|
|
$ |
|
||
Gains (losses) recorded for the period |
|
|
|
|
|
|
||
Recognized in other comprehensive income |
|
|
|
|
|
|
||
Interest recognized in interest income, net |
|
|
|
|
|
|
||
Foreign currency remeasurement recognized in other income (expense), net |
|
|
( |
) |
|
|
|
|
Reversal of expected credit loss recognized in other income (expense), net |
|
|
|
|
|
— |
|
|
Conversion into preferred equity securities |
|
|
( |
) |
|
|
— |
|
Realized foreign currency loss recognized in other income (expense), net |
|
|
( |
) |
|
|
— |
|
Fair value of Neo Medical Convertible Loan at June 30 |
|
$ |
— |
|
|
$ |
|
|
|
|
|
|
|
|
|
||
Contractual value of Neo Medical Convertible Loan at June 30 |
|
$ |
— |
|
|
$ |
|
|
Allowance for credit loss recognized in other income (expense), net |
|
|
— |
|
|
|
— |
|
Amortized cost basis of Neo Medical Convertible Loan at June 30 |
|
$ |
— |
|
|
$ |
|
|
Other Investments
Other investments represent assets and investments recorded at fair value that are not deemed to be material for disclosure on an individual basis. The fair value of these assets is based upon significant unobservable inputs, such as probability-weighted discounted cash flow models, requiring the Company to develop its own assumptions. Therefore, the Company has categorized these assets as Level 3 financial assets.
Lattus Contingent Consideration
In connection with the Merger, the Company assumed a contingent consideration obligation under a purchase agreement between SeaSpine and Lattus Spine LLC ("Lattus") executed in December 2022. Under the terms of the agreement, the Company may be required to make installment payments at certain dates based on future net sales of certain products (the "Lateral Products").
13
The estimated fair value of the Lattus contingent consideration is determined using a Monte Carlo simulation and a discounted cash flow model requiring significant inputs which are not observable in the market. The significant inputs include assumptions related to the estimated future sales of the products, revenue risk-adjusted discount rates, revenue volatility, and discount rates matched to the timing of payments.
(Unaudited, U.S. Dollars, in thousands) |
|
2024 |
|
|
2023 |
|
||
Lattus contingent consideration estimated fair value at January 1 |
|
$ |
|
|
$ |
— |
|
|
Contingent consideration assumed in the Merger |
|
|
— |
|
|
|
|
|
Increase (decrease) in fair value recognized in acquisition-related amortization and remeasurement |
|
|
|
|
|
( |
) |
|
Lattus contingent consideration estimated fair value at June 30 |
|
$ |
|
|
$ |
|
||
The following table provides quantitative information related to certain key assumptions utilized within the valuation as of June 30, 2024:
(Unaudited, U.S. Dollars, in thousands) |
|
Fair Value as of |
|
|
Unobservable inputs |
|
Estimate |
|
Lattus Contingent Consideration |
|
$ |
|
|
Counterparty discount rates |
|
||
|
|
|
|
|
Revenue risk-adjusted discount rates |
|
||
8. Commitments and Contingencies
In addition to the matters described in the paragraphs below, in the normal course of its business, the Company is involved in various lawsuits from time to time and may be subject to certain other contingencies. The Company believes any losses related to these matters are individually and collectively immaterial as to a possible loss and range of loss.
Arbitration claims with former executives
In September 2023, the Company’s Board of Directors (the "Board") terminated the employment of Keith Valentine, John Bostjancic, and Patrick Keran, who had served respectively as the Company’s President and Chief Executive Officer, Chief Financial Officer, and Chief Legal Officer. The Board’s decision followed an investigation conducted by independent outside legal counsel and directed and overseen by the Company’s independent directors. As a result of the investigation, the Board determined that each of these executives engaged in repeated inappropriate and offensive conduct that violated multiple code of conduct requirements and was inconsistent with the Company’s values and culture. The Company notified each of Messrs. Valentine, Bostjancic, and Keran that their respective terminations were being made for “Cause,” as defined in applicable employment-related agreements (including each executive’s respective Change in Control and Severance Agreement, dated June 19, 2023). The Company also notified each of Messrs. Valentine, Bostjancic, and Keran that it did not believe it was required to make any further payments to them, other than payment of salary through September 12, 2023. The Board also requested that Mr. Valentine resign as a director, which he did in October 2023.
In January 2024, the Company received written notices of arbitration claims from counsel to Messrs. Valentine, Bostjancic, and Keran. Each of the arbitration claims asserts that the respective former executive was wrongfully terminated for “Cause” because the former executive’s conduct did not meet the contractually applicable definition of “Cause.” The claims seek relief for, among other things, alleged breach of contract, defamation, false light invasion of privacy, deceit, as well as indemnification and advancement for attorneys’ fees. The
Commitments
As a result of the Merger, the Company became party to agreements with certain distributor partners that provide the Company with an option to purchase, and an option for those partners to require the Company to purchase, the distribution business of those partners at specified future dates. At such time, the Company or distributor may (in certain cases, subject to satisfying certain conditions) submit written notice to the other of its intention to exercise its rights and initiate or require the purchase. Upon receipt of the written notice, the Company and the distributor will work in good faith to consummate the purchase. Under certain of these agreements, the purchase price would be paid in shares of the Company's common stock, whereas for others, the purchase price
14
can be paid in cash or shares at the Company's option. Based on the closing price of the Company's common stock as of June 30, 2024, assuming the options under all the relevant agreements were exercised, the estimated total number of shares the Company would issue under these agreements was approximately
Italian Medical Device Payback (“IMDP”)
In 2015, the Italian Parliament introduced rules for entities that supply goods and services to the Italian National Healthcare System. A key provision of the law is a ‘payback’ measure, requiring medical device companies in Italy to make payments to the Italian government if medical device expenditures exceed regional maximum ceilings. Companies are required to make payments equal to a percentage of expenditures exceeding maximum regional caps.
In the third quarter of 2022, the Italian Ministry of Health provided guidelines to the Italian regions and provinces on seeking payback of expenditure overruns relating to the years ended December 31, 2015, through December 31, 2018. Since receiving the guidelines, several regions and provinces have requested payment from affected medical device companies, including the Company. The Company has taken legal action to dispute the legality of such measures. In July 2024, the Italian Constitutional Court issued two judgments following public hearings on the matter held in May 2024. These judgments (i) declared the payback system itself as constitutionally legitimate and (ii) extended previously communicated reductions in the payback liability for certain fiscal years to all medical device companies, regardless of whether or not they had waived their legal claims on the matter.
The Company accounts for the estimated cost of the IMDP as sales and marketing expense and periodically reassesses the liability based upon current facts and circumstances. As a result, the Company recorded an expense of $
9. Accumulated other comprehensive loss
The components of and changes in accumulated other comprehensive loss were as follows:
(Unaudited, U.S. Dollars, in thousands) |
|
Currency |
|
|
Neo Medical Convertible Loan |
|
|
Other Investments |
|
|
Accumulated Other |
|
||||
Balance at December 31, 2023 |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
|
Other comprehensive income (loss) |
|
|
( |
) |
|
|
|
|
|
— |
|
|
|
|
||
Income taxes |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Reclassification adjustment to: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other expense, net |
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Balance at June 30, 2024 |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
— |
|
|
$ |
( |
) |
10. Revenue recognition and accounts receivable
Revenue Recognition
The Company has two reporting segments: Global Spine and Global Orthopedics. Within the Global Spine reporting segment, there are two product categories: (i) Bone Growth Therapies, and (ii) Spinal Implants, Biologics, and Enabling Technologies.
15
The table below presents net sales by product category by reporting segment:
|
|
Three Months Ended June 30, |
|
|||||||||
(Unaudited, U.S. Dollars, in thousands) |
|
2024 |
|
|
2023 |
|
|
Change |
|
|||
Bone Growth Therapies |
|
$ |
|
|
$ |
|
|
|
% |
|||
Spinal Implants, Biologics, and Enabling Technologies |
|
|
|
|
|
|
|
|
% |
|||
Global Spine |
|
|
|
|
|
|
|
|
% |
|||
Global Orthopedics |
|
|
|
|
|
|
|
|
% |
|||
Net sales |
|
$ |
|
|
$ |
|
|
|
% |
|||
|
|
Six Months Ended June 30, |
|
|||||||||
(Unaudited, U.S. Dollars, in thousands) |
|
2024 |
|
|
2023 |
|
|
Change |
|
|||
Bone Growth Therapies |
|
$ |
|
|
$ |
|
|
|
% |
|||
Spinal Implants, Biologics, and Enabling Technologies |
|
|
|
|
|
|
|
|
% |
|||
Global Spine |
|
|
|
|
|
|
|
|
% |
|||
Global Orthopedics |
|
|
|
|
|
|
|
|
% |
|||
Net sales |
|
$ |
|
|
$ |
|
|
|
% |
|||
Product Sales and Marketing Service Fees
The table below presents product sales and marketing service fees, which are both components of net sales:
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
(Unaudited, U.S. Dollars, in thousands) |
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Product sales |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Marketing service fees |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net sales |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Product sales primarily consist of the sale of bone growth therapies devices, spinal implants, certain biologics, enabling technologies, and orthopedics products. Marketing service fees are received from MTF Biologics (“MTF”) based on total sales of biologics tissues sourced from MTF and relate solely to the Global Spine reporting segment. The Company partners with MTF to provide certain allograft solutions (HCT/Ps) for various spine, orthopedic and other bone repair needs, with this partnership allowing the Company to exclusively market certain biologic offerings.
Accounts receivable and related allowances
The following table provides a detail of changes in the Company’s allowance for expected credit losses for the three and six months ended June 30, 2024 and 2023:
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
(Unaudited, U.S. Dollars, in thousands) |
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Allowance for expected credit losses beginning balance |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Addition resulting from the Merger with SeaSpine |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Current period provision for expected credit losses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Write-offs charged against the allowance and other |
|
|
( |
) |
|
|
|
|
|
( |
) |
|
|
( |
) |
|
Effect of changes in foreign exchange rates |
|
|
( |
) |
|
|
|
|
|
( |
) |
|
|
|
||
Allowance for expected credit losses ending balance |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
16
11. Business segment information
The Company's operations are managed through
Corporate activities are comprised of operating expenses not directly identifiable within the two reporting segments, such as human resources, finance, legal, and information technology functions. The Company neither discretely allocates assets, other than goodwill, to its operating segments nor evaluates the operating segments using discrete asset information.
Global Spine
The Global Spine reporting segment offers two primary product categories: (i) Bone Growth Therapies and (ii) Spinal Implants, Biologics, and Enabling Technologies.
The Bone Growth Therapies product category manufactures, distributes, sells, and provides support services for market leading devices used adjunctively in high-risk spinal fusion procedures and to treat both nonunion and acute fractures in the orthopedic space. These Class III medical devices are indicated as an adjunctive, noninvasive treatment to improve fusion success rates in the cervical and lumbar spine as well as a therapeutic treatment for non-spine acute and nonunion fractures. This product category uses distributors and a direct sales channel to sell its devices to hospitals, healthcare providers, and patients, in the U.S.
Spinal Implants, Biologics, and Enabling Technologies is comprised of (i) a broad portfolio of spine fixation and motion preservation implant products used in surgical procedures of the spine, (ii) one of the most comprehensive biologics portfolios in both the demineralized bone matrix and cellular allograft market segments, and (iii) image-guided surgical solutions to facilitate degenerative, minimally invasive, and complex surgical procedures. Spinal Implants, Biologics, and Enabling Technologies products are sold through a network of distributors and sales representatives to hospitals and healthcare providers on a global basis for Spinal Implants and Enabling Technologies, and primarily within the U.S. for Biologics.
Global Orthopedics
The Global Orthopedics reporting segment offers products and solutions for limb deformity correction and complex limb reconstruction with a focus on use in trauma, adult and pediatric limb reconstruction, and foot and ankle procedures. This reporting segment specializes in the design, development, and marketing of external and internal fixation orthopedic products that are coupled with enabling digital technologies to serve the complete patient treatment pathway. We sell these products through a global network of distributors and sales representatives to hospitals, healthcare organizations, and healthcare providers.
17
The following table presents adjusted EBITDA, the primary metric used in managing the Company, by reporting segment:
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
(Unaudited, U.S. Dollars, in thousands) |
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Adjusted EBITDA by reporting segment |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Global Spine |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Global Orthopedics |
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
Adjusted EBITDA |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Reconciling items: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Corporate operating expenses |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Interest expense, net |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Depreciation and amortization |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Share-based compensation expense |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Foreign exchange impact |
|
|
|
|
|
( |
) |
|
|
|
|
|
( |
) |
||
SeaSpine merger-related costs |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Strategic investments |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Acquisition-related fair value adjustments |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest and loss on investments |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||
Litigation and investigation costs |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Succession charges |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Medical device regulation |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Loss before income taxes |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
The following table presents depreciation and amortization by reporting segment:
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
(Unaudited, U.S. Dollars, in thousands) |
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Global Spine |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Global Orthopedics |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Corporate |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Geographical information
The table below presents net sales by geographic destination for each reporting segment and for the consolidated Company:
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
(Unaudited, U.S. Dollars, in thousands) |
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Global Spine |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
International |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total Global Spine |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Global Orthopedics |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. |
|
|
|
|
|
|
|
|
|
|
|
|
||||
International |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total Global Orthopedics |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Consolidated |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. |
|
|
|
|
|
|
|
|
|
|
|
|
||||
International |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net sales |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
18
The following data includes net sales by geographic area:
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
(Unaudited, U.S. Dollars, in thousands) |
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
U.S. |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Italy |
|
|
|
|
|
|
|
|
|
|
|
|
||||
France |
|
|
|
|
|
|
|
|
|
|
|
|
||||
United Kingdom |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Germany |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Brazil |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Others |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net Sales |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
The following data includes property, plant, and equipment by geographic area:
(U.S. Dollars, in thousands) |
|
June 30, |
|
|
December 31, |
|
||
|
|
(Unaudited) |
|
|
|
|
||
U.S. |
|
$ |
|
|
$ |
|
||
Italy |
|
|
|
|
|
|
||
Germany |
|
|
|
|
|
|
||
Others |
|
|
|
|
|
|
||
Total |
|
$ |
|
|
$ |
|
||
12. Acquisition-related amortization and remeasurement
Acquisition-related amortization and remeasurement consists of (i) amortization related to intangible assets acquired through business combinations or asset acquisitions and (ii) remeasurement of any related contingent consideration arrangements, which are recognized immediately upon acquisition.
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
(Unaudited, U.S. Dollars, in thousands) |
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Amortization of acquired intangibles |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Changes in fair value of contingent consideration |
|
|
|
|
|
( |
) |
|
|
|
|
|
( |
) |
||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
13. Share-based compensation
Components of share-based compensation expense are as follows:
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
(Unaudited, U.S. Dollars, in thousands) |
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Cost of sales |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Sales and marketing |
|
|
|
|
|
|
|
|
|
|
|
|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
19
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
(Unaudited, U.S. Dollars, in thousands) |
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Stock options |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Market-based stock options |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||
Time-based restricted stock awards and units |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Market-based / performance-based restricted stock units |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Stock purchase plan |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Pursuant to the Merger Agreement, the equity awards of SeaSpine (including stock options and restricted stock units) outstanding as of immediately prior to the closing of the Merger were converted into equity awards denominated in shares of Orthofix common stock. The Company issued options to purchase
During the three months ended June 30, 2024, and 2023, the Company issued
Inducement plans
During 2024, the Company has appointed several new executives, including a new President and Chief Executive Officer, Chief Financial Officer, Chief People & Business Operations Officer, Chief Legal Officer, President of Global Spine, Chief Investor Relations and Communications Officer, President of Global Operations and Quality, and Chief Human Resources Officer. As inducements to accept employment with the Company, the individuals were awarded grants including, dependent on the individual, (i) market-based and/or time-based stock options, (ii) time-based restricted stock units, (iii) time-based cliff vesting restricted stock units, and (iv) market-based restricted stock units, valued in the aggregate across all award types at approximately $
14. Income taxes
Generally, income tax provisions for interim periods are based on an estimated annual income tax rate, adjusted for discrete tax items, with any changes affecting the estimated annual effective tax rate recorded in the interim period in which the change occurs. Due to the impact of losses not benefited by the Company’s U.S. and Italian operations, the Company determined the estimated annual effective tax rate method would not provide a reliable estimate of the Company’s overall annual effective tax rate. As such, the Company has calculated the tax provision using the actual effective rate for the three and six months ended June 30, 2024. Due to the impact of temporary differences on the U.S. current tax liability without any deferred tax benefit, the actual effective rate may vary in future quarters.
For the three months ended June 30, 2024, and 2023, the effective tax rate was (
20
15. Earnings per share (“EPS”)
For the three and six months ended June 30, 2024, no adjustments were made to net income for purposes of calculating basic and diluted EPS.
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
(Unaudited, In thousands) |
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Weighted average common shares-basic |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Effect of dilutive securities |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Unexercised stock options and stock purchase plan |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Unvested restricted stock units |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Weighted average common shares-diluted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
There were
21
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis of Orthofix Medical Inc.’s (sometimes referred to as “we,” “us” or “our”) financial condition and results of operations should be read in conjunction with the discussion under the heading “Forward-Looking Statements” and our condensed consolidated financial statements and related notes thereto appearing elsewhere in this Form 10-Q.
Executive Summary
Following our merger (the "Merger") with SeaSpine Holdings Corporation ("SeaSpine"), which was completed in January 2023, we are a leading global spine and orthopedics company with a comprehensive portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions, and a leading surgical navigation system. Headquartered in Lewisville, Texas, our spine and orthopedic products are distributed in more than 60 countries via our sales representatives and distributors. For more information, please visit www.Orthofix.com. Information included on our website is not incorporated into, or otherwise creates a part of, this report.
Notable financial metrics in the second quarter of 2024 and recent achievements include the following:
Results of Operations
The following table provides certain items in our condensed consolidated statements of operations as a percent of net sales:
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
(Unaudited) |
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Net sales |
|
|
100.0 |
|
|
|
100.0 |
|
|
|
100.0 |
|
|
|
100.0 |
|
Cost of sales |
|
|
32.2 |
|
|
|
36.1 |
|
|
|
32.3 |
|
|
|
36.5 |
|
Gross profit |
|
|
67.8 |
|
|
|
63.9 |
|
|
|
67.7 |
|
|
|
63.5 |
|
Sales and marketing |
|
|
50.4 |
|
|
|
53.0 |
|
|
|
51.7 |
|
|
|
53.3 |
|
General and administrative |
|
|
17.1 |
|
|
|
18.3 |
|
|
|
17.0 |
|
|
|
22.9 |
|
Research and development |
|
|
9.1 |
|
|
|
10.4 |
|
|
|
9.7 |
|
|
|
11.8 |
|
Acquisition-related amortization and remeasurement |
|
|
3.7 |
|
|
|
1.8 |
|
|
|
3.3 |
|
|
|
2.1 |
|
Operating loss |
|
|
(12.5 |
) |
|
|
(19.6 |
) |
|
|
(14.0 |
) |
|
|
(26.6 |
) |
Net loss |
|
|
(16.8 |
) |
|
|
(21.1 |
) |
|
|
(17.9 |
) |
|
|
(27.7 |
) |
22
Net Sales by Product Category and Reporting Segment
Our operations are managed through two reporting segments: Global Spine and Global Orthopedics. The following tables provide net sales by product category by reporting segment:
|
|
Three Months Ended |
|
|
Percentage Change |
|
||||||||||
(Unaudited, U.S. Dollars, in thousands) |
|
2024 |
|
|
2023 |
|
|
Reported |
|
|
Constant Currency |
|
||||
Bone Growth Therapies |
|
$ |
59,135 |
|
|
$ |
52,662 |
|
|
|
12.3 |
% |
|
|
12.3 |
% |
Spinal Implants, Biologics, and Enabling Technologies |
|
|
108,899 |
|
|
|
105,314 |
|
|
|
3.4 |
% |
|
|
3.4 |
% |
Global Spine |
|
|
168,034 |
|
|
|
157,976 |
|
|
|
6.4 |
% |
|
|
6.4 |
% |
Global Orthopedics |
|
|
30,586 |
|
|
|
29,040 |
|
|
|
5.3 |
% |
|
|
6.3 |
% |
Net sales |
|
$ |
198,620 |
|
|
$ |
187,016 |
|
|
|
6.2 |
% |
|
|
6.4 |
% |
|
|
Six Months Ended |
|
|
Percentage Change |
|
||||||||||
(Unaudited, U.S. Dollars, in thousands) |
|
2024 |
|
|
2023 |
|
|
Reported |
|
|
Constant Currency |
|
||||
Bone Growth Therapies |
|
$ |
111,612 |
|
|
$ |
100,376 |
|
|
|
11.2 |
% |
|
|
11.2 |
% |
Spinal Implants, Biologics, and Enabling Technologies |
|
|
217,715 |
|
|
|
206,806 |
|
|
|
5.3 |
% |
|
|
5.3 |
% |
Global Spine |
|
|
329,327 |
|
|
|
307,182 |
|
|
|
7.2 |
% |
|
|
7.2 |
% |
Global Orthopedics |
|
|
57,901 |
|
|
|
55,038 |
|
|
|
5.2 |
% |
|
|
5.1 |
% |
Net sales |
|
$ |
387,228 |
|
|
$ |
362,220 |
|
|
|
6.9 |
% |
|
|
6.9 |
% |
Global Spine
Global Spine offers the following product categories:
Three months ended June 30, 2024 compared to 2023
Net sales of $168.0 million, an increase of $10.1 million or 6.4%
Six months ended June 30, 2024 compared to 2023
Net sales of $329.3 million, an increase of $22.1 million or 7.2%
23
24
Global Orthopedics
Global Orthopedics offers products and solutions that allow physicians to successfully treat a variety of orthopedic conditions specifically related to limb reconstruction and deformity correction unrelated to the spine. Global Orthopedics distributes its products world-wide through a network of distributors and sales representatives to sell orthopedic products to hospitals and healthcare providers.
Three months ended June 30, 2024 compared to 2023
Net sales of $30.6 million, an increase of $1.5 million or 5.3%
Six months ended June 30, 2024 compared to 2023
Net sales of $57.9 million, an increase of $2.9 million or 5.2%
Gross Profit
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||||||||||
(Unaudited, U.S. Dollars, in thousands) |
|
2024 |
|
|
2023 |
|
|
% Change |
|
|
2024 |
|
|
2023 |
|
|
% Change |
|
||||||
Net sales |
|
$ |
198,620 |
|
|
$ |
187,016 |
|
|
|
6.2 |
% |
|
$ |
387,228 |
|
|
$ |
362,220 |
|
|
|
6.9 |
% |
Cost of sales |
|
|
63,871 |
|
|
|
67,465 |
|
|
|
(5.3 |
%) |
|
|
125,237 |
|
|
|
132,340 |
|
|
|
(5.4 |
%) |
Gross profit |
|
$ |
134,749 |
|
|
$ |
119,551 |
|
|
|
12.7 |
% |
|
$ |
261,991 |
|
|
$ |
229,880 |
|
|
|
14.0 |
% |
Gross margin |
|
|
67.8 |
% |
|
|
63.9 |
% |
|
|
3.9 |
% |
|
|
67.7 |
% |
|
|
63.5 |
% |
|
|
4.2 |
% |
Three months ended June 30, 2024 compared to 2023
Gross profit increased $15.2 million
Six months ended June 30, 2024 compared to 2023
Gross profit increased $32.1 million
25
Sales and Marketing Expense
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||||||||||
(Unaudited, U.S. Dollars, in thousands) |
|
2024 |
|
|
2023 |
|
|
% Change |
|
|
2024 |
|
|
2023 |
|
|
% Change |
|
||||||
Sales and marketing |
|
$ |
100,224 |
|
|
$ |
99,249 |
|
|
|
1.0 |
% |
|
$ |
200,267 |
|
|
$ |
193,040 |
|
|
|
3.7 |
% |
As a percentage of net sales |
|
|
50.4 |
% |
|
|
53.1 |
% |
|
|
(2.7 |
%) |
|
|
51.7 |
% |
|
|
53.3 |
% |
|
|
(1.6 |
%) |
Three months ended June 30, 2024 compared to 2023
Sales and marketing expense increased $1.0 million
Six months ended June 30, 2024 compared to 2023
Sales and marketing expense increased $7.2 million
General and Administrative Expense
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||||||||||
(Unaudited, U.S. Dollars, in thousands) |
|
2024 |
|
|
2023 |
|
|
% Change |
|
|
2024 |
|
|
2023 |
|
|
% Change |
|
||||||
General and administrative |
|
$ |
33,994 |
|
|
$ |
34,177 |
|
|
|
(0.5 |
%) |
|
$ |
65,642 |
|
|
$ |
82,988 |
|
|
|
(20.9 |
%) |
As a percentage of net sales |
|
|
17.1 |
% |
|
|
18.3 |
% |
|
|
(1.2 |
%) |
|
|
17.0 |
% |
|
|
22.9 |
% |
|
|
(5.9 |
%) |
Three months ended June 30, 2024 compared to 2023
General and administrative expense decreased $0.2 million
26
Six months ended June 30, 2024 compared to 2023
General and administrative expense decreased $17.3 million
Research and Development Expense
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||||||||||
(Unaudited, U.S. Dollars, in thousands) |
|
2024 |
|
|
2023 |
|
|
% Change |
|
|
2024 |
|
|
2023 |
|
|
% Change |
|
||||||
Research and development |
|
$ |
18,049 |
|
|
$ |
19,424 |
|
|
|
(7.1 |
%) |
|
$ |
37,541 |
|
|
$ |
42,731 |
|
|
|
(12.1 |
%) |
As a percentage of net sales |
|
|
9.1 |
% |
|
|
10.4 |
% |
|
|
(1.3 |
%) |
|
|
9.7 |
% |
|
|
11.8 |
% |
|
|
(2.1 |
%) |
Three months ended June 30, 2024 compared to 2023
Research and development expense decreased $1.4 million
Six months ended June 30, 2024 compared to 2023
Research and development expense decreased $5.2 million
Acquisition-related Amortization and Remeasurement
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||||||||||
(Unaudited, U.S. Dollars, in thousands) |
|
2024 |
|
|
2023 |
|
|
% Change |
|
|
2024 |
|
|
2023 |
|
|
% Change |
|
||||||
Acquisition-related amortization and remeasurement |
|
$ |
7,388 |
|
|
$ |
3,333 |
|
|
|
121.7 |
% |
|
$ |
12,784 |
|
|
$ |
7,467 |
|
|
|
71.2 |
% |
As a percentage of net sales |
|
|
3.7 |
% |
|
|
1.8 |
% |
|
|
1.9 |
% |
|
|
3.3 |
% |
|
|
2.0 |
% |
|
|
1.3 |
% |
Acquisition-related amortization and remeasurement consists of (i) amortization related to intangible assets acquired through business combinations or asset acquisitions and (ii) remeasurement of related contingent consideration arrangements, which are recognized immediately upon acquisition.
Three months ended June 30, 2024 compared to 2023
Acquisition-related amortization and remeasurement increased $4.1 million
27
Six months ended June 30, 2024 compared to 2023
Acquisition-related amortization and remeasurement increased $5.3 million
Non-operating Income and Expense
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||||||||||
(Unaudited, U.S. Dollars, in thousands) |
|
2024 |
|
|
2023 |
|
|
% Change |
|
|
2024 |
|
|
2023 |
|
|
% Change |
|
||||||
Interest expense, net |
|
$ |
(4,943 |
) |
|
$ |
(1,266 |
) |
|
|
290.4 |
% |
|
$ |
(9,501 |
) |
|
$ |
(2,555 |
) |
|
|
271.9 |
% |
Other income (expense), net |
|
|
(2,510 |
) |
|
|
(20 |
) |
|
|
12450.0 |
% |
|
|
(3,784 |
) |
|
|
656 |
|
|
|
(676.8 |
%) |
Three months ended June 30, 2024 compared to 2023
Interest expense, net increased $3.7 million
Other income (expense), net decreased $2.5 million
Six months ended June 30, 2024 compared to 2023
Interest expense, net increased $6.9 million
Other income (expense), net decreased $4.4 million
Income Taxes
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||||||||||
(Unaudited, U.S. Dollars, in thousands) |
|
2024 |
|
|
2023 |
|
|
% Change |
|
|
2024 |
|
|
2023 |
|
|
% Change |
|
||||||
Income tax expense |
|
$ |
1,084 |
|
|
$ |
1,508 |
|
|
|
(28.1 |
%) |
|
$ |
1,935 |
|
|
$ |
2,119 |
|
|
|
(8.7 |
%) |
Effective tax rate |
|
|
(3.3 |
%) |
|
|
(4.0 |
%) |
|
|
0.7 |
% |
|
|
(2.9 |
%) |
|
|
(2.2 |
%) |
|
|
(0.7 |
%) |
28
Three months ended June 30, 2024 compared to 2023
Six months ended June 30, 2024 compared to 2023
Liquidity and Capital Resources
Cash, cash equivalents, and restricted cash at June 30, 2024, totaled $28.9 million compared to $37.8 million at December 31, 2023. The following table presents the net change in cash, cash equivalents, and restricted cash for the six months ended June 30, 2024, and 2023, respectively:
|
|
Six Months Ended June 30, |
|
|||||||||
(Unaudited, U.S. Dollars, in thousands) |
|
2024 |
|
|
2023 |
|
|
Change |
|
|||
Net cash used in operating activities |
|
$ |
(9,611 |
) |
|
$ |
(39,536 |
) |
|
$ |
29,925 |
|
Net cash provided by (used in) investing activities |
|
|
(20,583 |
) |
|
|
4,265 |
|
|
|
(24,848 |
) |
Net cash provided by financing activities |
|
|
21,678 |
|
|
|
21,791 |
|
|
|
(113 |
) |
Effect of exchange rate changes on cash |
|
|
(375 |
) |
|
|
387 |
|
|
|
(762 |
) |
Net change in cash and cash equivalents |
|
$ |
(8,891 |
) |
|
$ |
(13,093 |
) |
|
$ |
4,202 |
|
The following table presents free cash flow, a non-GAAP financial measure, which is calculated by subtracting capital expenditures from net cash from operating activities:
|
|
Six Months Ended June 30, |
|
|||||||||
(Unaudited, U.S. Dollars, in thousands) |
|
2024 |
|
|
2023 |
|
|
Change |
|
|||
Net cash used in operating activities |
|
$ |
(9,611 |
) |
|
$ |
(39,536 |
) |
|
$ |
29,925 |
|
Capital expenditures |
|
|
(20,533 |
) |
|
|
(24,654 |
) |
|
|
4,121 |
|
Free cash flow |
|
$ |
(30,144 |
) |
|
$ |
(64,190 |
) |
|
$ |
34,046 |
|
Operating Activities
Cash flows from operating activities increased $29.9 million
Two of our primary working capital accounts are accounts receivable and inventory. Days sales in receivables were 57 days at June 30, 2024, compared to 55 days at June 30, 2023 (calculated using second quarter net sales and ending accounts receivable). Inventory turns improved to 1.2 times as of June 30, 2024 compared to 0.9 times as of June 30, 2023 (calculated using trailing twelve month cost of goods sold and ending net inventories).
29
Investing Activities
Cash flows from investing activities decreased $24.8 million
Financing Activities
Cash flows from financing activities decreased $0.1 million
Credit Facilities
On November 6, 2023, we entered into a Financing Agreement (the “Financing Agreement”) with Blue Torch Finance LLC and certain lenders party thereto. The Financing Agreement provides for a $100.0 million senior secured term loan (the “Initial Term Loan”), a $25.0 million senior secured delayed draw term loan facility (the “Delayed Draw Term Loan”), and a $25.0 million senior secured revolving credit facility (the “Revolving Credit Facility,” and together with the Initial Term Loan and the Delayed Draw Term Loan, the “Credit Facilities”), each of which mature on November 6, 2027. As of June 30, 2024, we had $100.0 million outstanding under the Initial Term Loan and $25.0 million outstanding under the Delayed Draw Term Loan.
The Financing Agreement contains financial covenants requiring us to maintain a minimum level of liquidity at all times, a maximum consolidated leverage ratio (measured on a quarterly basis), and a minimum asset coverage ratio (measured on a monthly basis). As of June 30, 2024, we were in compliance with all required financial covenants.
On March 15, 2024, we entered into Amendment No.1 to the Financing Agreement with Blue Torch Finance LLC (the "First Amendment"). Under the terms of the First Amendment, the parties agreed to reduce the number of business days to submit a notice of borrowing for the Delayed Draw Term Loan, and redefine certain terms within the asset coverage financial covenant. The maturity date remains November 6, 2027, for each of the Initial Term Loan, Delayed Draw Term Loan, and Revolving Credit Facility.
As of June 30, 2024, we had no borrowings on our available lines of credit in Italy, which provide up to an aggregate amount of €5.5 million ($5.9 million).
Other
For information regarding contingencies, see Note 8 to the Notes to the Unaudited Condensed Consolidated Financial Statements contained herein.
Lattus Spine LLC ("Lattus") Contingent Consideration
Under the terms of a contingent consideration obligation in a purchase agreement assumed in the Merger, we may be required to make installment payments at certain dates based on future net sales of certain products (the "Lateral Products"). The estimated fair value of the contingent consideration arrangement as of June 30, 2024, was $12.7 million; however, the actual amount ultimately paid could be higher or lower than the estimated fair value of the contingent consideration. As of June 30, 2024, we classified the remaining contingent consideration liability of $5.9 million and $6.8 million within other current liabilities and other long-term liabilities, respectively. For additional discussion of this matter, see Note 7 of the Notes to the Unaudited Condensed Consolidated Financial Statements.
Legion Innovations, LLC Asset Acquisition
On December 29, 2022, we entered into a technology assignment and royalty agreement with Legion Innovations, LLC, a U.S.-based medical device technology company, whereby we acquired intellectual property rights to certain assets. As consideration, we paid $0.2 million in January 2023, with additional payments contingent upon reaching future commercialization and revenue-based milestones.
IGEA S.p.A Exclusive License and Distribution Agreement
30
In April 2021, we entered into an Exclusive License and Distribution Agreement (the “License Agreement”) with IGEA S.p.A (“IGEA”), an Italian manufacturer and distributor of bone and cartilage stimulation systems. As consideration for the License Agreement, we agreed to pay up to $4.0 million, of which $0.5 million was paid in 2021, with certain payments contingent upon achieving an FDA milestone.
In May 2022, we achieved FDA approval pertaining to the acquired technology, triggering a contingent consideration milestone obligation of $3.5 million. Of this amount, $1.5 million was paid in 2022, $1.0 million was paid in May 2023, and $1.0 million was paid subsequent to the reporting period in July 2024.
Off-balance Sheet Arrangements
As of June 30, 2024, we did not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, cash flows, liquidity, capital expenditures or capital resources that are material to investors.
Contractual Obligations
There have been no material changes in any of our material contractual obligations as disclosed in our Form 10-K for the year ended December 31, 2023.
Critical Accounting Estimates
Our discussion of operating results is based upon the condensed consolidated financial statements and accompanying notes. The preparation of these statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amount of revenues and expenses during the reporting period. Our critical accounting estimates are described in Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2023. There have been no significant changes to our critical accounting estimates during the quarter covered by this report.
Recently Issued Accounting Pronouncements
See Note 2 of the Notes to the Unaudited Condensed Consolidated Financial Statements for detailed information regarding the status of recently issued or adopted accounting pronouncements.
Non-GAAP Financial Measures
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. We believe it is important to provide investors with the same non-GAAP financial measures used to supplement information regarding the performance and underlying trends of our business operations to facilitate comparisons to 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 U.S. GAAP results with non-GAAP financial measures.
The non-GAAP financial measures used in this filing may have limitations as analytical tools and should not be considered in isolation or as a replacement for U.S. 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 that can have a material effect on cash flows.
Constant Currency
Constant currency 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 U.S. GAAP measures, but is most commonly used by management to analyze net sales without the impact of changes in foreign currency rates.
Free Cash Flow
Free cash flow is calculated by subtracting capital expenditures from net cash from operating activities. Management uses free cash flow as 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.
31
Item 3. Quantitative and Qualitative Disclosures About Market Risk
There have been no material changes to our market risks as disclosed in our Form 10-K for the year ended December 31, 2023.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
At the end of the period covered by this report, under the supervision and with the participation of our management, including our President and Chief Executive Officer and our Chief Financial Officer, we performed an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures. As described below, as of December 31, 2023, management identified a material weakness in our internal control over financial reporting, which is an integral component of our disclosure controls and procedures. Our remediation efforts with respect to this material weakness are continuing, and we have determined that this material weakness is continuing as of June 30, 2024, as there have been no further control instances as of this date to conclude that the applicable controls have been remediated. As a result, our President and Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were not effective as of June 30, 2024.
Material Weakness in Internal Control over Financial Reporting
The Company’s management is responsible for establishing and maintaining adequate internal control over financial reporting (as such term is defined in the Exchange Act Rule 13a-15(f)). The Company’s internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the Company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with U.S. GAAP, and that receipts and expenditures of the Company are being made only in accordance with authorizations of management and directors of the Company; and (iii) provide reasonable assurance regarding the prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on the financial statements.
Internal control over financial reporting is designed to provide reasonable assurance to the Company’s management and Board of Directors regarding the preparation of reliable financial statements for external purposes in accordance with U.S. GAAP. Because of the inherent limitations in any internal control, no matter how well designed, misstatements may occur and not be prevented or detected. Accordingly, even effective internal control over financial reporting can provide only reasonable assurance with respect to financial statement preparation. Further, the evaluation of the effectiveness of internal control over financial reporting was made as of a specific date, and continued effectiveness in future periods is subject to the risks that controls may become inadequate because of changes in conditions or that the degree of compliance with the policies and procedures may decline.
In connection with the preparation and filing of the Annual Report for the year ended December 31, 2023 (the “2023 Annual Report”), the Company’s management, including our President and Chief Executive Officer and our Chief Financial Officer, conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2023, based on the framework set forth in “Internal Control—Integrated Framework (2013)” issued by the Committee of Sponsoring Organizations of the Treadway Commission (the COSO criteria). Based on its evaluation, the Company’s management concluded that our internal control over financial reporting was not effective as of December 31, 2023, due to a material weakness in the design and operation of certain management review controls pertaining to business combinations and assessing recoverability of goodwill, resulting from insufficient evidence supporting the precision over the determination of certain estimates and insufficient evidence supporting the operating effectiveness of the associated review controls. This material weakness did not result in any misstatements to the consolidated financial statements or disclosures.
Notwithstanding the material weakness, management has concluded that the financial statements included elsewhere in the 2023 Annual Report presented fairly, in all material respects, our financial position, results of operations, and cash flows in conformity with U.S. GAAP.
Remediation of the Material Weakness
Our management has worked, and continues to work, to strengthen our disclosure controls and procedures and internal control over financial reporting in connection with the material weakness described above. Subsequent to the identification of the material weakness, the Company has better aligned its current finance department staff to enhance the review and oversight of the accounting and finance functions. The Company has also added several key positions in its finance department, including a new Chief Financial Officer, a Senior Vice President of Finance and Strategy, and other supporting roles with backgrounds in financial reporting, technical accounting, and financial planning and analysis. The Company continues to implement the remediation efforts
32
described herein. These remediation efforts are being undertaken under the supervision of the Audit and Finance Committee of our Board of Directors.
We are in the process of implementing and continuing to refine the plan for remediation of the ineffective internal control over financial reporting described above. In addition, we have designed and are implementing the specific remediation initiatives described below:
We believe the remediation steps outlined above have improved and will continue to improve the effectiveness of our internal control over financial reporting. We are committed to remediating the material weakness and we are making progress in that effort. The actions we are taking are subject to ongoing senior management review, as well as oversight from the Audit and Finance Committee. When fully implemented and operational, we believe the measures described above will remediate the underlying causes of the control deficiencies that gave rise to the material weakness and will strengthen our internal control over financial reporting. However, remediation efforts are expected to continue beyond the quarter ended June 30, 2024. Further, we will not be able to fully remediate this material weakness until these steps have been completed and have been operating effectively for a sufficient period of time. We may also identify additional measures that may be required to remediate the material weakness in our internal control over financial reporting, necessitating further action.
Changes in Internal Control over Financial Reporting
Other than the remediation activities described above, there have not been any changes in our internal control over financial reporting during the quarterly period covered by this report that have materially affected or are reasonably likely to materially affect, our internal control over financial reporting.
33
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
For information regarding legal proceedings, see Note 8 to the Notes to the Unaudited Condensed Consolidated Financial Statements contained herein, which is incorporated by reference into this Part II, Item 1.
Item 1A. Risk Factors
There have been no material changes from the risk factors disclosed in "Part I, Item 1A. Risk Factors” in our Form 10-K for the year ended December 31, 2023.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
We have not made any repurchases of our common stock during the second quarter of 2024.
Item 3. Defaults Upon Senior Securities
Not applicable.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
During the last fiscal quarter, none of our
Item 6. Exhibits
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31.1* |
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Rule 13a-14(a)/15d-14(a) Certification of Chief Executive Officer. |
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31.2* |
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Rule 13a-14(a)/15d-14(a) Certification of Chief Financial Officer. |
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32.1# |
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Section 1350 Certifications of each of the Chief Executive Officer and Chief Financial Officer. |
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101.INS* |
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Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document). |
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101.SCH* |
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Inline XBRL Taxonomy Extension Schema Document. |
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101.CAL* |
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Inline XBRL Taxonomy Extension Calculation Linkbase Document. |
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101.DEF* |
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Inline XBRL Taxonomy Extension Definition Linkbase Document. |
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101.LAB* |
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Inline XBRL Taxonomy Extension Label Linkbase Document. |
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101.PRE* |
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Inline XBRL Taxonomy Extension Presentation Linkbase Document. |
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104* |
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Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101). |
* Filed herewith.
# Furnished herewith.
37
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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ORTHOFIX MEDICAL INC. |
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Date: August 6, 2024 |
By: |
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/s/ MASSIMO CALAFIORE |
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Name: |
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Massimo Calafiore |
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Title: |
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President and Chief Executive Officer |
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Date: August 6, 2024 |
By: |
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/s/ JULIE ANDREWS |
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Name: |
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Julie Andrews |
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Title: |
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Chief Financial Officer |
38
Exhibit 31.1
CERTIFICATION
I, Massimo Calafiore, certify that:
1. I have reviewed this quarterly report on Form 10-Q for the quarterly period ended June 30, 2024, of Orthofix Medical Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a. designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b. designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c. evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d. disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has material affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a. all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b. any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Dated: August 6, 2024 |
By: |
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/s/ MASSIMO CALAFIORE |
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Name: |
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Massimo Calafiore |
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Title: |
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President and Chief Executive Officer, Director |
Exhibit 31.2
CERTIFICATION
I, Julie Andrews, certify that:
1. I have reviewed this quarterly report on Form 10-Q for the quarterly period ended June 30, 2024, of Orthofix Medical Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a. designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b. designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c. evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d. disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has material affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a. all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b. any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Dated: August 6, 2024 |
By: |
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/s/ JULIE ANDREWS |
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Name: |
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Julie Andrews |
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Title: |
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Chief Financial Officer |
Exhibit 32.1
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO SECTION 906
OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of Orthofix Medical Inc. (“Orthofix”) on Form 10-Q for the quarterly period ended June 30, 2024, (the “Report”), as filed with the Securities and Exchange Commission on the date hereof, Massimo Calafiore, President and Chief Executive Officer, Director, and Julie Andrews, Chief Financial Officer, each certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to his knowledge:
1. The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of Orthofix.
Dated: August 6, 2024 |
/s/ MASSIMO CALAFIORE |
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Name: |
Massimo Calafiore |
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Title: |
President and Chief Executive Officer, Director |
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Dated: August 6, 2024 |
/s/ JULIE ANDREWS |
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Name: |
Julie Andrews |
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Title: |
Chief Financial Officer |