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

Date of Report (Date of earliest event reported): May 07, 2024

 

 

ORTHOFIX MEDICAL INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

0-19961

98-1340767

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

3451 Plano Parkway

 

Lewisville, Texas

 

75056

(Address of Principal Executive Offices)

 

(Zip Code)

 

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:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common stock, $0.10 par value per share

 

OFIX

 

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

 

99.1

Press release, dated May 7, 2024

 

 

99.2

Corporate Investor Relations Presentation, dated May 7, 2024

 

 

99.3

Supplemental Financials, dated May 7, 2024

 

 

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

 


 

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.

 

 

Orthofix Medical Inc.

 

 

By:

 

 

/s/ JULIE ANDREWS

 

 

 

Julie Andrews

Chief Financial Officer

 

 

 

Date: May 7, 2024

 


 

Exhibit 99.1

img236010591_0.jpg 

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:

 

 

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 and 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

%

 

1


 

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)

2


 

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.

 

Company Contact

 

Louisa Smith, Gilmartin Group

 

ir@orthofix.com

 

 

3


 

ORTHOFIX MEDICAL INC.

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

 

 

37.7

 

 

 

35.7

 

Diluted

 

 

37.7

 

 

 

35.7

 

 

4


 

ORTHOFIX MEDICAL INC.

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

 

 

5


 

 

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

%

 

6


 

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.

7


Slide 1

May 2024 Corporate Investor Deck


Slide 2

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.


Slide 3

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


Slide 4

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


Slide 5

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


Slide 6

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


Slide 7

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


Slide 8

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™


Slide 9

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


Slide 10

Servicing the full continuum of surgical care Enabling Technologies FLASH™ Navigation with 7D Technology Machine-vision Navigation System


Slide 11

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 


Slide 12

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


Slide 13

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


Slide 14

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


Slide 15

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


Slide 16

*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


Slide 17

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


Slide 18

Click to edit Master title style THANK YOU


Slide 19

APPENDIX A


Slide 20

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.

Slide 1

Supplemental Financials 1Q24 Earnings May 7, 2024


Slide 2

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.  


Slide 3

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


Slide 4

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


Slide 5

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%


Slide 6

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


Slide 7

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


Slide 8

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


Slide 9

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


Slide 10

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


Slide 11

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%


Slide 12

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.

v3.24.1.u1
Document And Entity Information
May 07, 2024
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date May 07, 2024
Entity Registrant Name ORTHOFIX MEDICAL INC.
Entity Central Index Key 0000884624
Entity Emerging Growth Company false
Entity File Number 0-19961
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 98-1340767
Entity Address, Address Line One 3451 Plano Parkway
Entity Address, City or Town Lewisville
Entity Address, State or Province TX
Entity Address, Postal Zip Code 75056
City Area Code (214)
Local Phone Number 937-2000
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common stock, $0.10 par value per share
Trading Symbol OFIX
Security Exchange Name NASDAQ

Orthofix Medical (NASDAQ:OFIX)
過去 株価チャート
から 4 2024 まで 5 2024 Orthofix Medicalのチャートをもっと見るにはこちらをクリック
Orthofix Medical (NASDAQ:OFIX)
過去 株価チャート
から 5 2023 まで 5 2024 Orthofix Medicalのチャートをもっと見るにはこちらをクリック