false000088462400008846242024-05-072024-05-07
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Date of Report (Date of earliest event reported): May 07, 2024 |
ORTHOFIX MEDICAL INC.
(Exact name of Registrant as Specified in Its Charter)
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Delaware |
0-19961 |
98-1340767 |
(State or Other Jurisdiction
of Incorporation) |
(Commission File Number) |
(IRS Employer
Identification No.) |
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3451 Plano Parkway |
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Lewisville, Texas |
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75056 |
(Address of Principal Executive Offices) |
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(Zip Code) |
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Registrant’s Telephone Number, Including Area Code: (214) 937-2000 |
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading
Symbol(s) |
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Name of each exchange on which registered
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Common stock, $0.10 par value per share |
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OFIX |
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Nasdaq Global Select Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
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. ☐
Item 2.02. Results of Operations and Financial Condition.
On May 7, 2024, Orthofix Medical Inc. (the “Company”) issued a press release announcing, among other things, its financial results for the first quarter ended March 31, 2024. A copy of the press release is furnished herewith as Exhibit 99.1 and attached hereto.
The information furnished in this Item 2.02, including the exhibit furnished herewith as Exhibit 99.1, will not be treated as “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. This information will not be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended (the “Securities Act”), or into another filing under the Exchange Act, unless that filing expressly incorporates by reference this Item 2.02 of this report.
Discussion of Non-GAAP Financial Measures
In addition to using standard measures of performance and liquidity that are recognized in accordance with accounting principles generally accepted in the United States of America ("GAAP"), the Company uses additional financial measures excluding certain GAAP items ("non-GAAP measures"), such as:
Constant Currency
Constant currency is a non-GAAP measure, which the Company calculates by using foreign currency rates from the comparable, prior-year period, to present net sales at comparable rates. Constant currency can be presented for numerous GAAP measures, but is most commonly used by management to analyze net sales without the impact of changes in foreign currency rates.
Free Cash Flow
Free cash flow is a non-GAAP financial measure, which is calculated by subtracting capital expenditures from cash flow from operating activities. Free cash flow is an important indicator of how much cash is generated or used by the Company's business operations, including capital expenditures. Management uses free cash flow to measure progress on its capital efficiency and cash flow initiatives.
Adjusted Gross Profit and Adjusted Gross Margin
Adjusted gross profit represents GAAP gross profit with adjustments to exclude the impact of the certain items recorded to cost of goods sold. Such potential adjustments are listed within the section below under the header "Non-GAAP Adjustments." Adjusted gross margin represents adjusted gross profit as a percentage of GAAP net sales.
Adjusted Operating Expenses
Adjusted operating expenses represents GAAP expenses, such as sales and marketing expense, general and administrative expense, and research and development expense, with adjustments to exclude the impact of the certain items recorded in such GAAP operating expenses. Potential adjustments are listed within the section below under the header "Non-GAAP Adjustments."
EBITDA
EBITDA is a non-GAAP financial measure, which the Company calculates by adding interest expense (income), net; income tax expense (benefit); and depreciation and amortization to net income (loss). EBITDA provides management with additional insight to the Company's results of operations. Adjusted EBITDA, which is the primary metric used by the Company's Chief Operating Decision Maker in managing the business, consists of EBITDA with adjustments to exclude certain items listed within the section below under the header "Non-GAAP Adjustments."
Non-GAAP Adjustments
The Company's non-GAAP financial measures provide management with additional insight to the Company's results of operations and reflect the exclusion of the following items:
•Share-based compensation expense – Costs related to awards granted under the Company's share-based compensation plans, which include stock options, performance-based or market-based stock options, restricted stock, performance-based or market-based restricted stock, and stock issued under the Company's stock purchase plan; see the share-based compensation footnote in the Company's Form 10-Q for the quarter ended March 31, 2024, for an allocation of these costs by consolidated statement of operations line item. Management excludes this item when evaluating the Company's operating performance as it represents a non-cash expense.
•Foreign exchange impact – Gains and losses related to foreign currency transactions, which are recorded as other income (expense), net. Management excludes this item when evaluating the Company's operating results as it is primarily a non-cash expense or benefit and is non-operating in nature.
•SeaSpine merger-related costs – Costs related to the Company's merger with SeaSpine Holdings Corporation ("SeaSpine"), which was consummated in January 2023, including costs relating to integration efforts, severance and retention costs, product rationalization charges, contract termination penalties, and professional fees related to the merger. Management excludes this item when evaluating the Company's operating results as these costs associated with this event
are of a temporary nature, are not related to the Company's core operating performance, and are not expected to recur at a similar frequency and magnitude in the future.
•Strategic investments – Costs related to the Company's strategic investments, such as due diligence and integration costs (unrelated to the merger with SeaSpine), which are primarily recorded as general and administrative expenses. These costs are not factored into the evaluation of the Company's performance by management because they are of a temporary nature, not related to the Company's core operating performance, and because the frequency and amount of such costs vary significantly based on the timing and magnitude of the Company's strategic investments.
•Acquisition-related fair value adjustments – Comprised of (i) gains and losses related to remeasurement of contingent consideration to fair value, which are recorded as operating expenses and (ii) recognized costs related to acquired in-process research and development ("IPR&D") assets, which are expensed immediately, and (iii) amortization of acquired inventory fair market value adjustments. Management excludes this item when evaluating the Company's operating results as the remeasurement of contingent consideration is primarily non-cash in nature, the frequency and amount of IPR&D charges can vary significantly based on the timing and magnitude of the Company's acquisition transactions, and inventory fair market value adjustments are of a temporary and non-cash nature.
•Amortization of acquired long-lived assets – Amortization of intangible assets acquired in business combinations or asset acquisitions, including items such as developed technologies, customer relationships, trade names, manufacturing agreements, and other intangible assets, and any impairment of acquired goodwill, which are recorded in cost of sales or operating expenses. This item also includes depreciation recognized on adjustments to the fair value of certain long-lived assets acquired in the merger with SeaSpine. Management excludes this item when evaluating the Company's operating performance as it represents a non-cash expense.
•(Gain) Loss on investment securities – Net gains or losses recognized (realized or unrealized) within other income (expense), net relating to certain of our investments. Management excludes this item when evaluating the Company's operating performance as it typically represents a non-cash gain or loss and is not related to the Company's core operating performance.
•Litigation and investigation costs – Inclusive of (i) adverse or favorable legal judgments or negotiated legal settlements and certain related legal expenses and (ii) amounts incurred in relation to and as a result of the Board of Directors’ investigation conducted by independent outside legal counsel that resulted in the departure of three former executive officers and certain charges stemming from these actions. These charges are primarily recorded within general and administrative expenses. Management excludes these items when evaluating the Company's operating results as these costs and/or benefits can vary significantly based on the timing, frequency, and magnitude of litigation matters.
•Medical device regulation – Incremental costs incurred (i) to establish initial compliance with the regulations set forth by the European Union Medical Device Regulation (“MDR”) related to the Company's currently-approved medical devices, which are recorded primarily as research and development expenses, and (ii) related to rationalization of certain product lines that the Company does not expect to continue to market subsequent to the effective date of these regulations, which are recorded primarily as costs of sales. Management excludes this item when evaluating the Company's operating results as these costs are temporary in nature and associated with events that are not expected to recur at a similar frequency and magnitude in the future.
•All other - Comprised of individually insignificant adjustments to the Company's operating results that either represent non-cash gains or losses or are not considered to be related to the Company's core operating performance.
Usefulness and Limitations of Non-GAAP Financial Measures
Management uses non-GAAP measures to evaluate performance period-over-period, analyze the underlying trends in the Company's business, assess the Company's performance relative to its competitors, and establish operational goals and forecasts used in allocating resources. Management uses these non-GAAP measures as the basis for evaluating the ability of the Company's underlying operations to generate cash, prior to required investments in working capital, and to further its understanding of the performance of the Company's business units.
Material Limitations Associated with the Use of Non-GAAP Financial Measures
The non-GAAP financial measures described above may have limitations as analytical tools, and should not be considered in isolation or as a replacement for GAAP financial measures. Some of the limitations associated with the use of these non-GAAP financial measures are that they exclude items that reflect an economic cost and can have a material effect on cash flows. Similarly, certain non-cash expenses, such as share-based compensation, do not directly impact cash flows, but are part of total compensation costs accounted for under GAAP.
Compensation for Limitations Associated with Use of Non-GAAP Financial Measures
The Company compensates for the limitations of its non-GAAP financial measures by relying upon GAAP results to gain a complete picture of the Company's performance. GAAP results provide management with the ability to understand the Company's performance
based on a defined set of criteria. The Company provides reconciliations of the non-GAAP financial measures to the most directly comparable GAAP measures and encourages investors to review these reconciliations.
Usefulness of Non-GAAP Financial Measures to Investors
The Company believes that providing non-GAAP financial measures that exclude certain items provides investors with greater transparency to the information used by management in its financial and operational decision-making. Management believes it is important to provide investors with the same non-GAAP financial measures it uses to supplement information regarding the performance and underlying trends of the Company's business operations in order to facilitate comparisons to the Company's historical operating results and internally evaluate the effectiveness of the Company's operating strategies. The Company believes that these non-GAAP financial measures also facilitates comparisons of the Company's underlying operating performance with other companies in the industry that also supplement their GAAP results with non-GAAP financial measures.
Item 7.01 Regulation FD Disclosure.
The Company expects to use the corporate investor relations presentations furnished as Exhibit 99.2 and Exhibit 99.3 to this report, in whole or in part, and possibly with modifications, in connection with presentations to investors, analysts, and others during the fiscal year ending December 31, 2024.
The information furnished in this Item 7.01, including the exhibits furnished herewith as Exhibit 99.2 and Exhibit 99.3, will not be treated as “filed” for the purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section. This information will not be deemed incorporated by reference into any filing under the Securities Act, or into another filing under the Exchange Act, unless that filing expressly incorporates by reference this Item 7.01 of this report.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Orthofix Medical Inc. |
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By: |
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/s/ JULIE ANDREWS |
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Julie Andrews Chief Financial Officer |
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Date: May 7, 2024
Exhibit 99.1
Orthofix Reports First Quarter 2024 Results
Recent Highlights
•Net sales of $188.6 million, an increase of 7.7% on a reported basis and 7.5% on a constant currency basis over prior year
•Bone Growth Therapies net sales growth of 10%, marking five consecutive quarters with double-digit net sales increases
•U.S. Spine Fixation1 net sales growth of 16%, driven by distribution expansion and further penetration in existing accounts
•Global Orthopedics net sales growth of 5% on a reported basis, primarily driven by U.S. Orthopedic net sales growth of 23%
•First quarter 2024 net loss of $36 million; Non-GAAP Adjusted EBITDA of $8 million, an increase of $4.5 million, a 220 basis point expansion over prior year
•Midpoint of full year 2024 net sales guidance raised; range narrowed to $790.0-$795.0 million
LEWISVILLE, Texas — May 7, 2024 — Orthofix Medical Inc. (NASDAQ:OFIX) today reported its financial results for the first quarter ended March 31, 2024.
First quarter net sales were $188.6 million, an increase of 7.7% on a reported basis and 7.5% on a constant currency basis. Net loss was $(36.0) million and earnings per share ("EPS") was $(0.95) on a reported basis, representing an improvement of 44% when compared to the prior year period. Non-GAAP adjusted EBITDA was $7.7 million for the first quarter, representing a 220 basis point expansion over the prior year period.
“Orthofix executed well on a number of key priorities in the first quarter of the year and delivered notable growth in all of its U.S. businesses. We saw strength in many areas of our broadening portfolio, including outsized performance in U.S. Spine Fixation, U.S. Orthopedics, and the Bone Growth Therapies fracture market, with growth of 16%, 23%, and 17%, respectively,” said Massimo Calafiore, President and Chief Executive Officer of Orthofix. “I remain confident in the fundamentals of the Company and believe we are poised to continue driving value through profitable growth, increased operating leverage, and portfolio synergies. I look forward to sustaining the first quarter’s momentum through the remainder of 2024 and taking further advantage of the many opportunities for market share gain that lie within all of our core segments.”
1 Spine fixation is comprised of the Company's Spinal Implants product category, excluding motion preservation product offerings
Financial Results Overview
First Quarter 2024 Net Sales and Financial Results
The following table provides net sales by major product category by reporting segment on a reporting basis:
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Three Months Ended March 31, |
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(Unaudited, U.S. Dollars, in millions) |
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2024 |
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2023 |
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Change |
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Constant
Currency
Change |
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Bone Growth Therapies |
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$ |
52.5 |
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$ |
47.7 |
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10.0 |
% |
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10.0 |
% |
Spinal Implants, Biologics and Enabling Technologies |
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108.8 |
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101.5 |
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7.2 |
% |
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7.2 |
% |
Global Spine |
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161.3 |
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149.2 |
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8.1 |
% |
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8.1 |
% |
Global Orthopedics |
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27.3 |
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26.0 |
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5.1 |
% |
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3.8 |
% |
Net sales |
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$ |
188.6 |
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$ |
175.2 |
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7.7 |
% |
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7.5 |
% |
Gross margins were 67.5% for the quarter and were 70.3% on a non-GAAP adjusted basis.
Net loss was $(36.0) million, or $(0.95) per share, compared to net loss of $(60.9) million, or $(1.71) per share in the prior year period. Non-GAAP adjusted EBITDA was $7.7 million, or 4.1% of net sales, compared to non-GAAP adjusted EBITDA of $3.2 million, or 1.8% of net sales, in the prior year period.
Liquidity
Cash, cash equivalents, and restricted cash on March 31, 2024, totaled $29.5 million compared to $37.8 million on December 31, 2023. As of March 31, 2024 the Company had $125.0 million in borrowings outstanding under its four year $150.0 million Financing Agreement.
Business Outlook
The Company is providing updated 2024 full year guidance as follows:
•Net sales to range between $790 million to $795 million, representing implied growth of 6% to 7% year-over-year on a constant currency basis; narrowed from previous guidance of $785 million to $795 million. These expectations are based on the current foreign currency exchange rates and do not take into account any additional potential exchange rate changes that may occur this year.
•Reiterating previous guidance for non-GAAP adjusted EBITDA ranging from $62 million to $67 million
•Expect to be free cash flow positive for Q4 2024
Conference Call
Orthofix will host a conference call today at 8:30 AM Eastern time to discuss the Company's financial results for the quarter ended March 31, 2024. Interested parties may access the conference call by dialing (888) 330-2508 in the U.S., and (240) 789-2735 in all other locations, and referencing the access code 9556380. A replay of the call will be available for three weeks by dialing (800) 770-2030 in the U.S., and (647) 362-9199 in all other locations, and entering the access code 9556380. A webcast of the conference call may be accessed at ir.Orthofix.com.
About Orthofix
Orthofix is a 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 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 R&D, 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. For more information, please visit www.orthofix.com.
Forward-Looking Statements
This communication contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, relating to our business and financial outlook, which are based on our current beliefs, assumptions, expectations, estimates, forecasts and projections. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “intends,” “predicts,” “potential,” or “continue” or other comparable terminology. Forward-looking statements in this communication include the Company's expectations regarding net sales and adjusted EBITDA for the year ended December 31, 2024. Forward-looking statements are not guarantees of our future performance, are based on our current expectations and assumptions regarding our business, the economy and other future conditions, and are subject to risks, uncertainties and changes in circumstances that are difficult to predict, including the risks described in Part I, Item 1A under the heading Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2023 (the “2023 Form 10-K”), and in Part II, Item 1A under the heading Risk Factors in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024. Factors that could cause future results to differ from those expressed by forward-looking statements include, but are not limited to, (i) our ability to maintain operations to support our customers and patients in the near-term and to capitalize on future growth opportunities, (ii)
risks associated with acceptance of surgical products and procedures by surgeons and hospitals, (iii) development and acceptance of new products or product enhancements, (iv) clinical and statistical verification of the benefits achieved via the use of our products, (v) our ability to adequately manage inventory, (vi) our ability to recruit and retain management and key personnel, and (vii) the other risks and uncertainties more fully described in our periodic filings with the Securities and Exchange Commission (the “SEC”). As a result of these various risks, our actual outcomes and results may differ materially from those expressed in these forward-looking statements.
This list of risks, uncertainties, and other factors is not complete. We discuss some of these matters more fully, as well as certain risk factors that could affect our business, financial condition, results of operations, and prospects, in reports we file from time-to-time with the SEC, which are available to read at www.sec.gov. Any or all forward-looking statements that we make may turn out to be wrong (due to inaccurate assumptions that we make or otherwise), and our actual outcomes and results may differ materially from those expressed in these forward-looking statements. You should not place undue reliance on any of these forward-looking statements. Further, any forward-looking statement speaks only as of the date hereof, unless it is specifically otherwise stated to be made as of a different date. We undertake no obligation to update, and expressly disclaim any duty to update, our forward-looking statements, whether as a result of circumstances or events that arise after the date hereof, new information, or otherwise, except as required by law.
The Company is unable to provide expectations of GAAP income (loss) before income taxes, the closest comparable GAAP measures to adjusted EBITDA (which is a non-GAAP measure), on a forward-looking basis because the Company is unable to predict without unreasonable efforts the ultimate outcome of matters (including acquisition-related expenses, accounting fair value adjustments, and other such items) that will determine the quantitative amount of the items excluded in calculating adjusted EBITDA, which items are further described in the reconciliation tables and related descriptions below. These items are uncertain, depend on various factors, and could be material to the Company’s results computed in accordance with GAAP.
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Company Contact |
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Louisa Smith, Gilmartin Group |
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ir@orthofix.com |
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ORTHOFIX MEDICAL INC.
Condensed Consolidated Statements of Operations
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Three Months Ended |
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March 31, |
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(U.S. Dollars, in thousands, except share and per share data) |
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2024 |
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2023 |
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(Unaudited) |
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Net sales |
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$ |
188,608 |
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$ |
175,204 |
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Cost of sales |
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61,366 |
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64,875 |
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Gross profit |
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127,242 |
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110,329 |
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Sales and marketing |
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100,043 |
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93,791 |
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General and administrative |
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31,648 |
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48,811 |
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Research and development |
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19,492 |
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23,307 |
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Acquisition-related amortization and remeasurement |
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5,396 |
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4,134 |
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Operating loss |
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(29,337 |
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(59,714 |
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Interest expense, net |
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(4,558 |
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(1,289 |
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Other income (expense), net |
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(1,274 |
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676 |
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Loss before income taxes |
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(35,169 |
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(60,327 |
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Income tax expense |
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(851 |
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(611 |
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Net loss |
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$ |
(36,020 |
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$ |
(60,938 |
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Net loss per common share: |
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Basic |
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$ |
(0.95 |
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$ |
(1.71 |
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Diluted |
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(0.95 |
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(1.71 |
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Weighted average number of common shares (in millions): |
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Basic |
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37.7 |
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35.7 |
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Diluted |
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37.7 |
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35.7 |
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ORTHOFIX MEDICAL INC.
Condensed Consolidated Balance Sheets
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(U.S. Dollars, in thousands, except par value data) |
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March 31,
2024 |
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December 31,
2023 |
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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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$ |
26,964 |
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$ |
33,107 |
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Restricted Cash |
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2,500 |
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4,650 |
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Accounts receivable, net of allowances of $8,398 and $7,130, respectively |
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125,617 |
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128,098 |
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Inventories |
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219,076 |
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222,166 |
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Prepaid expenses and other current assets |
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24,821 |
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32,422 |
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Total current assets |
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398,978 |
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420,443 |
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Property, plant, and equipment, net |
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158,132 |
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159,060 |
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Intangible assets, net |
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112,761 |
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117,490 |
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Goodwill |
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194,934 |
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194,934 |
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Other long-term assets |
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41,245 |
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33,388 |
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Total assets |
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$ |
906,050 |
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$ |
925,315 |
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Liabilities and shareholders’ equity |
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Current liabilities |
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Accounts payable |
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$ |
57,147 |
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$ |
58,357 |
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Current portion of long-term debt |
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3,125 |
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1,250 |
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Current portion of finance lease liability |
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724 |
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708 |
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Other current liabilities |
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89,625 |
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104,908 |
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Total current liabilities |
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150,621 |
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165,223 |
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Long-term debt |
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115,071 |
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93,107 |
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Long-term portion of finance lease liability |
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18,345 |
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18,532 |
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Other long-term liabilities |
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51,698 |
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49,723 |
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Total liabilities |
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335,735 |
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326,585 |
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Contingencies |
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Shareholders’ equity |
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Common shares $0.10 par value; 100,000 shares authorized;
37,410 and 37,165 issued and outstanding as of March 31,
2024 and December 31, 2023, respectively |
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3,741 |
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3,717 |
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Additional paid-in capital |
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753,398 |
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746,450 |
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Accumulated deficit |
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(186,164 |
) |
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(150,144 |
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Accumulated other comprehensive loss |
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(660 |
) |
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(1,293 |
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Total shareholders’ equity |
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570,315 |
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598,730 |
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Total liabilities and shareholders’ equity |
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$ |
906,050 |
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$ |
925,315 |
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ORTHOFIX MEDICAL INC.
Non-GAAP Financial Measures
The following tables present reconciliations of various financial measures calculated in accordance with U.S. generally accepted accounting principles (“GAAP”), to various non-GAAP financial measures that exclude (or in the case of free cash flow, include) items specified in the tables. The GAAP measures shown in the tables below represent the most comparable GAAP measure to the applicable non-GAAP measure(s) shown in the table. For further information regarding the nature of these exclusions, why the Company believes that these non-GAAP financial measures provide useful information to investors, the specific manner in which management uses these measures, and some of the limitations associated with the use of these measures, please refer to the Company's Current Report on Form 8-K regarding this press release filed today with the SEC available on the SEC's website at www.sec.gov and on the “Investors” page of the Company’s website at www.orthofix.com.
Adjusted Gross Profit and Adjusted Gross Margin
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
(Unaudited, U.S. Dollars, in thousands) |
|
2024 |
|
|
2023 |
|
Gross profit |
|
$ |
127,242 |
|
|
$ |
110,329 |
|
Share-based compensation expense |
|
|
537 |
|
|
|
471 |
|
SeaSpine merger-related costs |
|
|
1,303 |
|
|
|
703 |
|
Strategic investments |
|
|
65 |
|
|
|
180 |
|
Acquisition-related fair value adjustments |
|
|
3,047 |
|
|
|
11,636 |
|
Amortization/depreciation of acquired long-lived assets |
|
|
318 |
|
|
|
— |
|
Medical device regulation |
|
|
— |
|
|
|
629 |
|
Adjusted gross profit |
|
$ |
132,512 |
|
|
$ |
123,948 |
|
Adjusted gross margin |
|
|
70.3 |
% |
|
|
70.7 |
% |
Adjusted EBITDA
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
(Unaudited, U.S. Dollars, in thousands) |
|
2024 |
|
|
2023 |
|
Loss before income taxes |
|
$ |
(35,169 |
) |
|
$ |
(60,327 |
) |
Interest expense, net |
|
|
4,558 |
|
|
|
1,289 |
|
Depreciation and amortization |
|
|
14,862 |
|
|
|
12,670 |
|
Share-based compensation expense |
|
|
8,800 |
|
|
|
13,020 |
|
Foreign exchange impact |
|
|
1,588 |
|
|
|
(583 |
) |
SeaSpine merger-related costs |
|
|
4,520 |
|
|
|
20,740 |
|
Strategic investments |
|
|
120 |
|
|
|
661 |
|
Acquisition-related fair value adjustments |
|
|
4,217 |
|
|
|
11,636 |
|
Litigation and investigation costs |
|
|
2,260 |
|
|
|
469 |
|
Succession charges |
|
|
2,210 |
|
|
|
— |
|
Medical device regulation |
|
|
— |
|
|
|
3,629 |
|
All other |
|
|
(301 |
) |
|
|
— |
|
Adjusted EBITDA |
|
$ |
7,665 |
|
|
$ |
3,204 |
|
Adjusted EBITDA as a percentage of net sales |
|
|
4.1 |
% |
|
|
1.8 |
% |
Cash Flow and Free Cash Flow
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
(Unaudited, U.S. Dollars, in thousands) |
|
2024 |
|
|
2023 |
|
Net cash from operating activities |
|
$ |
(18,595 |
) |
|
$ |
(34,020 |
) |
Net cash from investing activities |
|
|
(10,867 |
) |
|
|
17,084 |
|
Net cash from financing activities |
|
|
21,453 |
|
|
|
15,983 |
|
Effect of exchange rate changes on cash |
|
|
(284 |
) |
|
|
221 |
|
Net change in cash and cash equivalents |
|
$ |
(8,293 |
) |
|
$ |
(732 |
) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
(Unaudited, U.S. Dollars, in thousands) |
|
2024 |
|
|
2023 |
|
Net cash from operating activities |
|
$ |
(18,595 |
) |
|
$ |
(34,020 |
) |
Capital expenditures |
|
|
(10,817 |
) |
|
|
(11,835 |
) |
Free cash flow |
|
$ |
(29,412 |
) |
|
$ |
(45,855 |
) |
Reconciliation of Non-GAAP Financial Measures to Reported Operating Expenses
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
(Unaudited, U.S. Dollars, in thousands) |
|
2024 |
|
|
2023 |
|
Net sales |
|
$ |
188,608 |
|
|
$ |
175,204 |
|
Sales and marketing, as reported |
|
|
100,043 |
|
|
|
93,791 |
|
Reconciling items impacting sales and marketing: |
|
|
|
|
|
|
Strategic investments |
|
|
(2,219 |
) |
|
|
(2,099 |
) |
Litigation and investigation costs |
|
|
— |
|
|
|
(105 |
) |
Medical device regulation |
|
|
— |
|
|
|
(5 |
) |
Amortization/depreciation of acquired long-lived assets |
|
|
(178 |
) |
|
|
— |
|
Sales and marketing, as adjusted |
|
$ |
97,646 |
|
|
$ |
91,582 |
|
Sales and marketing as a percentage of net sales, as adjusted |
|
|
51.8 |
% |
|
|
52.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
(Unaudited, U.S. Dollars, in thousands) |
|
2024 |
|
|
2023 |
|
Net sales |
|
$ |
188,608 |
|
|
$ |
175,204 |
|
General and administrative, as reported |
|
|
31,648 |
|
|
|
48,811 |
|
Reconciling items impacting general and administrative: |
|
|
|
|
|
|
Strategic investments |
|
|
(1,211 |
) |
|
|
(17,298 |
) |
Amortization/depreciation of acquired long-lived assets |
|
|
(70 |
) |
|
|
— |
|
Litigation and investigation costs |
|
|
(2,260 |
) |
|
|
(364 |
) |
Succession charges |
|
|
(2,210 |
) |
|
|
— |
|
General and administrative, as adjusted |
|
$ |
25,897 |
|
|
$ |
31,149 |
|
General and administrative as a percentage of net sales, as adjusted |
|
|
13.7 |
% |
|
|
17.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
(Unaudited, U.S. Dollars, in thousands) |
|
2024 |
|
|
2023 |
|
Net sales |
|
$ |
188,608 |
|
|
$ |
175,204 |
|
Research and development, as reported |
|
|
19,492 |
|
|
|
23,307 |
|
Reconciling items impacting research and development: |
|
|
|
|
|
|
Strategic investments |
|
|
(236 |
) |
|
|
(1,884 |
) |
Medical device regulations |
|
|
— |
|
|
|
(2,990 |
) |
Research and development, as adjusted |
|
$ |
19,256 |
|
|
$ |
18,433 |
|
Research and development as a percentage of net sales, as adjusted |
|
|
10.2 |
% |
|
|
10.5 |
% |
Source
Orthofix Medical Inc.
May 2024 Corporate Investor Deck
Forward Looking Statements This presentation contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, relating to our business and financial outlook, which are based on our current beliefs, assumptions, expectations, estimates, forecasts and projections. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “intends,” “predicts,” “potential,” or “continue” or other comparable terminology. Forward-looking statements in this communication include the Company's expectations regarding net sales and adjusted EBITDA for the year ended December 31, 2024. Forward-looking statements are not guarantees of our future performance, are based on our current expectations and assumptions regarding our business, the economy and other future conditions, and are subject to risks, uncertainties and changes in circumstances that are difficult to predict, including the risks described in Part I, Item 1A under the heading Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2023 (the “2023 Form 10-K”), and in Part II, Item 1A under the heading Risk Factors in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024. Factors that could cause future results to differ from those expressed by forward-looking statements include, but are not limited to, (i) our ability to maintain operations to support our customers and patients in the near-term and to capitalize on future growth opportunities, (ii) risks associated with acceptance of surgical products and procedures by surgeons and hospitals, (iii) development and acceptance of new products or product enhancements, (iv) clinical and statistical verification of the benefits achieved via the use of our products, (v) our ability to adequately manage inventory, (vi) our ability to recruit and retain management and key personnel, and (vii) the other risks and uncertainties more fully described in our periodic filings with the Securities and Exchange Commission (the “SEC”). As a result of these various risks, our actual outcomes and results may differ materially from those expressed in these forward-looking statements. This list of risks, uncertainties, and other factors is not complete. We discuss some of these matters more fully, as well as certain risk factors that could affect our business, financial condition, results of operations, and prospects, in reports we file from time-to-time with the SEC, which are available to read at www.sec.gov. Any or all forward-looking statements that we make may turn out to be wrong (due to inaccurate assumptions that we make or otherwise), and our actual outcomes and results may differ materially from those expressed in these forward-looking statements. You should not place undue reliance on any of these forward-looking statements. Further, any forward-looking statement speaks only as of the date hereof, unless it is specifically otherwise stated to be made as of a different date. We undertake no obligation to update, and expressly disclaim any duty to update, our forward-looking statements, whether as a result of circumstances or events that arise after the date hereof, new information, or otherwise, except as required by law. The Company is unable to provide expectations of GAAP income (loss) before income taxes, the closest comparable GAAP measures to adjusted EBITDA (which is a non-GAAP measure), on a forward-looking basis because the Company is unable to predict without unreasonable efforts the ultimate outcome of matters (including acquisition-related expenses, accounting fair value adjustments, and other such items) that will determine the quantitative amount of the items excluded in calculating adjusted EBITDA, which items are further described in the reconciliation tables and related descriptions below. These items are uncertain, depend on various factors, and could be material to the Company’s results computed in accordance with GAAP.
a Extensive Portfolio Solutions with Complementary Technologies Improved Clinical Outcomes & Economic Value Expanded Distribution Channels & Global Commercial Reach $150M Credit Facility Provides Liquidity to Fund Growth and Scale Visionary Leadership Team with Deep Sector Experience Large Addressable Markets with High Growth Opportunities Investment Highlights Building a Leading Global Spine & Orthopedics Company
Senior Leadership Team Experienced leadership with 250+ years in spine/orthopedics Jason Shallenberger President Bone Growth Therapies Julie Andrews Chief Financial Officer Roberto Donadello Senior Vice President Global Operations Beau Standish, PhD, PEng Chief Enabling Technologies Officer Kimberley Elting President, Global Orthopedics Ehab Esmail Senior Vice President, Global Quality, Regulatory & Clinical Affairs Andres Cedron Chief Legal Officer Jill Mason Chief Compliance and Risk Officer, Deputy General Counsel, and Assistant Corporate Secretary Massimo Calafiore President and Chief Executive Officer Lucas Vitale Chief People and Business Operations Officer
Complementary High Growth Portfolio SmartTRAK® 2022 – 2026 U.S. Estimates *Focused growth segments include Enabling Technologies, Motion Preservation, Interbody, DBM, LLIF/OLIF, MIS and Long Bone Stimulation $7B of Focused High-Growth Market Segments* | 6.1% CAGR Motion Preservation Spinal Fixation Spinal Implants Limb Reconstruction Deformity Correction Orthopedics Cellular Allograft Demineralized Bone Matrices Synthetic Bone Grafts Biologics Machine-vision 7D FLASH™ Navigation Enabling Technologies Bone Growth Stimulation Non-Surgical Alternative Regenerative Technology Bone Growth Therapies Synergistic Product Platform
Orthopedics Specialized portfolio of limb reconstruction and deformity correction products that address the most challenging orthopedic conditions Complex Fracture Management Digital Healthcare Adult & Pediatric Limb Reconstruction Complex Foot & Ankle Reconstruction TrueLok™ Ring Fixation System TrueLok™ EVO Ring Fixation System Galaxy™ Fixation System XCaliber™ Hybrid Fixator AHN Ankle Hindfoot Nailing™ System G-Beam Fusion Beaming System™ TL-HEX™ TrueLok Hexapod System JuniOrtho Pediatric Plating System™ Fitbone® Limb-Lengthening System OrthoNext™ Platform System for Preoperative Planning
Cervical Thoracolumbar Fixation Interbodies Spinal Implants Comprehensive best-in-class spinal portfolio driving rapid market adoption M6-C™ Artificial Cervical Disc Explorer® TO Expandable Interbody Construx™ Mini PTC Spacer System with Nanovate™ Technology Reef® TO NanoMetalene® with Reef Topography ® Admiral™ Anterior Cervical Plating System Shoreline® Anterior Cervical Standalone System NorthStar® Posterior Cervical Fixation System Forza™ TI Ti Spacer System with Nanovate™ Technology Firebird™ NXG Spinal Fixation System Mariner® Modular Pedicle Screw System FIREBIRD ™ SI SI Fusion System Mariner® Deformity Adult Deformity Posterior Fixation System WaveForm™ 3D Interbody WaveForm™ C 3D Interbody ForzaXP™ Expandable Spacer System Meridian™ Spacer System
Demineralized Bone Putty Cellular Allograft Demineralized Bone Fiber Biologics Full spectrum of biologic solutions to enhance the fusion process and promote bone repair and growth Procedural Solutions Traditional Allograft Graft Delivery Synthetic Trinity Elite™ OsteoStrand® Plus Torrent® & Torrent C Accell Evo3® & Evo3® c DynaGraft® II & OrthoBlast® II Legacy™ Opus™ BA Opus™ Mg Set Mozaik™ RAPID® O-Genesis™ OsteoBallast® OsteoBallast MT NorthStar™ Facet Fusion FiberFuse™ OsteoCove™
Bone Growth Therapies Bone Healing Therapy Spine Fusion Therapy Safe and effective treatment and non-surgical alternative to overcome bone healing challenges AccelStim™ Bone Healing Therapy PhysioStim™ Bone Growth Therapy CervicalStim™ Spinal Fusion Therapy SpinalStim™ Spinal Fusion Therapy # 1 Prescribed bone growth stimulator We are proud to be the first to offer a free recycling program so patients can properly dispose of their devices after use. PEMF technology approved Since 1986 Prescribed devices 1,100,000
Servicing the full continuum of surgical care Enabling Technologies FLASH™ Navigation with 7D Technology Machine-vision Navigation System
Diversified & Complementary Business with Broad Commercial Reach $760M* TTM Revenue *As of March 31, 2024 ~84% U.S. | ~16% OUS Products distributed in 60+ countries
Commercial Strategy Framework Geographic Footprint Double-digit growth in global commercial reach Focused Distributors Expanded market penetration with increased dedicated distribution Diverse Sales Strategy Cross selling opportunities across direct and distribution-based sales channels Clinical Relevance Proven track record of procedural excellence, backed by compelling clinical evidence, spanning multiple markets Training and Education Programs Complementary training and education programs to deliver value to surgeons and distributors Continuum of Care Comprehensive product portfolio from pre-operative planning through post surgical COMMERCIAL STRATEGY FRAMEWORK
Key Growth Drivers Orthopedics Growth driven by channel expansion and further products launches expanding our leading TrueLok™ and Fitbone™ franchises and penetration of US market Spinal Fixation Industry leading product and procedure launches per year & continued penetration into emerging markets Product Utilization Higher product utilization per procedure from more complete portfolio Spinal Implants & Biologics Continue share taking at above market growth, from 50+ product launches since 2018 Higher Revenue Per Case Increased participation in higher revenue complex and deformity procedures from full commercialization of Mariner® Adult Deformity Platform BGT Fracture DD growth driven by the recent AccelStim™ launch, future product launches & increasing channel investments Enabling Technologies Growth from full commercial recent launch of MIS module and higher conversion of revenue earnout arrangements Distributor Partners Onboard additional transformative & more focused distributor partners
Orthofix Constant Currency is calculated by applying foreign currency rates applicable to the comparable, prior-year period to present the current period net sales at comparable rates. Constant currency can be presented for numerous GAAP measures, but is commonly used by management to analyze net sales excluding the impact of changes in foreign currency rates. The reasons for and nature of non-GAAP disclosures by the Company, descriptions of the adjustments used to calculate those non-GAAP financial measures, and reconciliations of those non-GAAP financial measures to the most comparable GAAP financial measure, are provided in the Company’s press release issued and Current Report on Form 8-K filed on May 7, 2024. 23% Q1 2024 US Orthopedics YoY growth $189M Q1 2024 Revenue 7.7% Growth YoY as reported 7.5% Growth YoY at constant currency(1) 70.3% Q1 2024 Adjusted Gross Margin(2) $7.7M Q1 2024 Adjusted EBITDA 220 bps Growth YoY(2) $29.5M Cash & Cash Equivalents, 3/31/2024 Includes $2.5M in restricted cash 10% Q1 2024 Bone Growth Therapies YoY Growth 5th consecutive quarter of double-digit growth Q1 2024 Highlights
Full Year Guidance* 2024 $790 – 795M Revenue $62 – 67M Adjusted EBITDA Revenue ranges above represent 6% to 7% year-over-year growth Guidance information is as of May 7, 2024, based on guidance provided by Orthofix leadership on that date. Inclusion of this information in this presentation is not a confirmation or an update of and should not be construed or otherwise assumed to reflect ay confirmation or update of, that guidance by Orthofix leadership as of any date other than May 7, 2024. *As of the Company’s Q1 2024 Earnings Call hosted on May 7, 2024 Positive Free Cash Flow for Q4 2024
*Revenue synergies of ~$25M expected by 2025 **Cost synergies of ~$50M expected by 3 years post close of merger with incremental opportunity to reduce stock-based compensation expense **Based on due diligence, including revenue zip code analysis performed by 3rd party Broader Commercial Reach Accelerated adoption of differentiated technologies Sustainable growth & value creation Strengthened U.S. and international sales channels Rapid product innovation driving market-share taking Complementary Portfolios #1 Prescribed bone growth stimulator portfolio in the U.S. Broadest advanced DBM portfolio, market leading cellular allograft, and comprehensive line of synthetics Next generation differentiated artificial cervical disc Meaningful Revenue & Cost Synergies Est. Revenue Synergies: >$25M* Est. Cost Synergies: ~$50M** Working Capital & Capex Synergies Merger Highlights
a Building a Leading Global Spine & Orthopedics Company Investment Highlights Extensive Portfolio Solutions with Complementary Technologies Improved Clinical Outcomes & Economic Value Expanded Distribution Channels & Global Commercial Reach $150M Credit Facility Provides Liquidity to Fund Growth and Scale Visionary Leadership Team with Deep Sector Experience Large Addressable Markets with High Growth Opportunities
Click to edit Master title style THANK YOU
APPENDIX A
Non-GAAP Financial Measures On the Company’s Q1 2024 earnings call held on May 7, 2024, Orthofix management presented Adjusted EBITDA and Adjusted Gross Margin, both of which are non-GAAP financial measures, for the 1st quarter of 2024. The following tables present reconciliations of various financial measures calculated in accordance with U.S. generally accepted accounting principles (“GAAP”), to various non-GAAP financial measures that exclude (or in the case of free cash flow, include) items specified in the tables. The GAAP measures shown in the tables below represent the most comparable GAAP measure to the applicable non-GAAP measure(s) shown in the table. For further information regarding the nature of these exclusions, why the Company believes that these non-GAAP financial measures provide useful information to investors, the specific manner in which management uses these measures, and some of the limitations associated with the use of these measures, please refer to the Company's Current Report on Form 8-K regarding this press release filed today with the SEC available on the SEC's website at www.sec.gov and on the “Investors” page of the Company’s website at www.orthofix.com.
Supplemental Financials 1Q24 Earnings May 7, 2024
Forward Looking Statements This presentation contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, relating to our business and financial outlook, which are based on our current beliefs, assumptions, expectations, estimates, forecasts and projections. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “intends,” “predicts,” “potential,” or “continue” or other comparable terminology. Forward-looking statements in this communication include the Company's expectations regarding net sales and adjusted EBITDA for the year ended December 31, 2024. Forward-looking statements are not guarantees of our future performance, are based on our current expectations and assumptions regarding our business, the economy and other future conditions, and are subject to risks, uncertainties and changes in circumstances that are difficult to predict, including the risks described in Part I, Item 1A under the heading Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2023 (the “2023 Form 10-K”), and in Part II, Item 1A under the heading Risk Factors in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024. Factors that could cause future results to differ from those expressed by forward-looking statements include, but are not limited to, (i) our ability to maintain operations to support our customers and patients in the near-term and to capitalize on future growth opportunities, (ii) risks associated with acceptance of surgical products and procedures by surgeons and hospitals, (iii) development and acceptance of new products or product enhancements, (iv) clinical and statistical verification of the benefits achieved via the use of our products, (v) our ability to adequately manage inventory, (vi) our ability to recruit and retain management and key personnel, (vii) global economic instability and potential supply chain disruption caused by Russia’s invasion of Ukraine and resulting sanctions, and (viii) the other risks and uncertainties more fully described in our periodic filings with the Securities and Exchange Commission (the “SEC”). As a result of these various risks, our actual outcomes and results may differ materially from those expressed in these forward-looking statements. This list of risks, uncertainties, and other factors is not complete. We discuss some of these matters more fully, as well as certain risk factors that could affect our business, financial condition, results of operations, and prospects, in reports we file from time-to-time with the SEC, which are available to read at www.sec.gov. Any or all forward-looking statements that we make may turn out to be wrong (due to inaccurate assumptions that we make or otherwise), and our actual outcomes and results may differ materially from those expressed in these forward-looking statements. You should not place undue reliance on any of these forward-looking statements. Further, any forward-looking statement speaks only as of the date hereof, unless it is specifically otherwise stated to be made as of a different date. We undertake no obligation to update, and expressly disclaim any duty to update, our forward-looking statements, whether as a result of circumstances or events that arise after the date hereof, new information, or otherwise, except as required by law. The Company is unable to provide expectations of GAAP income (loss) before income taxes, the closest comparable GAAP measures to Adjusted EBITDA (which is a non-GAAP measure), on a forward-looking basis because the Company is unable to predict without unreasonable efforts the ultimate outcome of matters (including acquisition-related expenses, accounting fair value adjustments, and other such items) that will determine the quantitative amount of the items excluded in calculating Adjusted EBITDA, which items are further described in the reconciliation tables and related descriptions below. These items are uncertain, depend on various factors, and could be material to the Company’s results computed in accordance with GAAP.
Q1 2024 Results Summary Q1 Total Net Sales: $188.6M; 7.5% y/y growth Q1 Adjusted EBITDA: $7.7M; 4.1% of sales vs $3.2M in 1Q23; 1.8% of sales Q1 Adjusted Gross Margin: 70.3% vs 70.7% in 1Q23 Q1 Sales & Marketing: $100.0M; 53.0% of sales vs $93.8M in 1Q23; 53.5% of sales Q1 R&D: $19.5M; 10.3% of sales vs $23.3M in 1Q23; 13.3% of sales
Q1 2024 Key Messages Strong fundamentals with compelling growth opportunity and value proposition across diverse portfolio Merger thesis remains intact Broad product portfolio driving penetration of new and existing customers Prioritization of profitable growth; free cash flow positive in 4Q24 Solid operational execution with >200 basis points adjusted EBITDA expansion
First Quarter Revenues Q1 Total Revenues $188.6M ; +7.5% y/y* * Y/Y Growth (Decline) on Constant Currency basis Diversified and complementary portfolio platform with broad clinical reach Bone Growth Therapies $52.5M; +10.0% Global Orthopedics $27.3M; +3.8%* Global Spinal Implants, Biologics, & Enabling Technology $108.8M; +7.2%* International Spinal Implants, Biologics & Enabling Technologies $9.4M; (3.3%)* U.S. Spinal Implants, Biologics & Enabling Technologies $99.4M; +8.3% 91.3% 8.7%
SmartTRAK® 2022 – 2026 U.S. Estimates *Focused growth segments include Enabling Technologies, Motion Preservation, Interbody, DBM, LLIF/OLIF, MIS and Long Bone Stimulation $7B of Focused High-Growth Market Segments* | 6.1% CAGR Motion Preservation Spinal Fixation Spinal Implants Limb Reconstruction Deformity Correction Orthopedics Cellular Allograft Demineralized Bone Matrices Synthetic Bone Grafts Biologics Machine-vision 7D FLASH™ Navigation Enabling Technologies Bone Growth Stimulation Non-Surgical Alternative Regenerative Technology Bone Growth Therapies Synergistic Product Platform Complementary Portfolios
2024 Full Year Guidance* $790 – 795M Revenue $62 – 67M Adjusted EBITDA Revenue ranges above represent 6% to 7% year-over-year growth Guidance information is as of May 7, 2024, based on guidance provided by Orthofix leadership on that date. Inclusion of this information in this presentation is not a confirmation or an update of, and should not be construed or otherwise assumed to reflect ay confirmation or update of, that guidance by Orthofix leadership as of any date other than May 7, 2024. *As of the Company’s Q1 2024 Earnings Call hosted on May 7, 2024 Cash Flow Positive for Q4 2024
2024 Key Priorities Profitable Growth Synergistic Product Platform Innovation Sustainable differentiated growth engine Adjusted EBITDA improvements Effective management of cash flow Optimization of cost synergies Cash flow positive for Q4 2024 Avoid “growth at all cost” Efficient working capital management Leverage technologies and sales channels across all product segments Diversified portfolio with complementary multifunctional applications Continuum of musculoskeletal care integrated by enabling technologies Cross selling opportunities Continued innovation as a growth driver Allocation of resources to high value businesses Product development that enables market share gain Extension of existing product pipeline
Condensed Consolidated Balance Sheets (U.S. Dollars, in thousands, except par value data) March 31, 2024 December 31, 2023 (unaudited) Assets Current assets Cash and cash equivalents $ 26,964 $ 33,107 Restricted cash 2,500 4,650 Accounts receivable, net of allowances of $8,398 and $7,130, respectively 125,617 128,098 Inventories 219,076 222,166 Prepaid expenses and other current assets 24,821 32,422 Total current assets 398,978 420,443 Property, plant, and equipment, net 158,132 159,060 Intangible assets, net 112,761 117,490 Goodwill 194,934 194,934 Other long-term assets 41,245 33,388 Total assets $ 906,050 $ 925,315 Liabilities and shareholders’ equity Current liabilities Accounts payable $ 57,147 $ 58,357 Current portion of long-term debt 3,125 1,250 Current portion of finance lease liability 724 708 Other current liabilities 89,625 104,908 Total current liabilities 150,621 165,223 Long-term debt 115,071 93,107 Long-term portion of finance lease liability 18,345 18,532 Other long-term liabilities 51,698 49,723 Total liabilities 335,735 326,585 Contingencies Shareholders’ equity Common shares $0.10 par value; 100,000 shares authorized; 37,410 and 37,165 issued and outstanding as of March 31, 2024 and December 31, 2023, respectively 3,741 3,717 Additional paid-in capital 753,398 746,450 Accumulated deficit (186,164) (150,144) Accumulated other comprehensive loss (660) (1,293) Total shareholders’ equity 570,315 598,730 Total liabilities and shareholders’ equity $ 906,050 $ 925,315
Condensed Consolidated Statements of Operations Three Months Ended March 31, (U.S. Dollars, in thousands, except share and per share data) 2024 2023 (Unaudited) Net sales $ 188,608 $ 175,204 Cost of sales 61,366 64,875 Gross profit 127,242 110,329 Sales and marketing 100,043 93,791 General and administrative 31,648 48,811 Research and development 19,492 23,307 Acquisition-related amortization and remeasurement 5,396 4,134 Operating loss (29,337) (59,714) Interest expense, net (4,558) (1,289) Other income (expense), net (1,274) 676 Loss before income taxes (35,169) (60,327) Income tax expense (851) (611) Net loss $ (36,020) $ (60,938) Net loss per common share: Basic $ (0.95) $ (1.71) Diluted (0.95) (1.71) Weighted average number of common shares (in millions): Basic 37,741 35,734 Diluted 37,741 35,734
Net Sales by Major Product Category (as reported) Three Months Ended March 31, (Unaudited, U.S. Dollars, in millions) 2024 2023 Change Constant Currency Change Bone Growth Therapies $ 52.5 $ 47.7 10.0% 10.0% Spinal Implants, Biologics, & Enabling Technologies 108.8 101.5 7.2% 7.2% Global Spine 161.3 149.2 8.1% 8.1% Global Orthopedics 27.3 26.0 5.1% 3.8% Net sales $ 188.6 $ 175.2 7.7% 7.5%
Non-GAAP Financial Measures On the Company’s Q1 2024 earnings call held on May 7, 2024, Orthofix management presented Adjusted EBITDA and Adjusted Gross Margin, both of which are non-GAAP financial measures, for the 1st quarter of 2024. The following tables present reconciliations of various financial measures calculated in accordance with U.S. generally accepted accounting principles (“GAAP”), to various non-GAAP financial measures that exclude (or in the case of free cash flow, include) items specified in the tables. The GAAP measures shown in the tables below represent the most comparable GAAP measure to the applicable non-GAAP measure(s) shown in the table. For further information regarding the nature of these exclusions, why the Company believes that these non-GAAP financial measures provide useful information to investors, the specific manner in which management uses these measures, and some of the limitations associated with the use of these measures, please refer to the Company's Current Report on Form 8-K regarding this press release filed today with the SEC available on the SEC's website at www.sec.gov and on the “Investors” page of the Company’s website at www.orthofix.com.
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