Record Results Reflect Strong Execution as
Company Focuses on Most Profitable Growth Opportunities in Spine,
Orthopedics and Bone Growth Therapies
Orthofix Medical Inc. (NASDAQ:OFIX), a leading global medical
technology company, today reported its financial results for the
fourth quarter and full-year ended December 31, 2024, and provided
full-year 2025 financial guidance.
Highlights
- Record fourth quarter 2024 net sales of $215.7 million, an
increase of 8% on a reported and constant currency basis compared
to fourth quarter 2023
- U.S. Spine Fixation1 net sales growth of 12% compared to
fourth quarter 2023, driven by distribution expansion and further
penetration in existing accounts
- Record Bone Growth Therapies ("BGT") net sales of $63.9
million, representing growth of 9% and BGT Fracture net sales
growth of 10% compared to fourth quarter 2023
- Record Global Orthopedics net sales of $35.8 million,
representing constant currency growth of 18% and U.S. Orthopedics
net sales growth of 21% compared to fourth quarter 2023
- Company entered into record number of 7D FLASH™ Navigation
System placements for the full-year 2024
- Fourth quarter 2024 net loss of $(29.1) million; Non-GAAP
adjusted EBITDA of $23.9 million, an increase of $4.3 million, with
adjusted EBITDA margin expanding approximately 130 basis points
compared to fourth quarter 2023
- Free cash flow of $15.2 million in fourth quarter 2024, a
significant improvement in cash usage compared to previous
quarters
- Company increases long-term net sales compound annual growth
rate ("CAGR") target to 6.5% to 7.5% from previous net sales CAGR
target of 6% to 7%
Fourth quarter 2024 net sales were $215.7 million, an increase
of 8% on a reported and constant currency basis. Net loss was
$(29.1) million and earnings per share ("EPS") was $(0.75) on a
reported basis, representing a decline of 27% when compared to the
same prior year period. Non-GAAP adjusted EBITDA was $23.9 million
for the fourth quarter, representing 22% growth compared to the
fourth quarter of 2023.
Full-year 2024 net sales were $799.5 million, an increase of 7%
on a reported and constant currency basis. Net loss was $(126.0)
million and EPS was $(3.30), representing an improvement of 20%
when compared to the same prior year period. Non-GAAP adjusted
EBITDA was $67.4 million for the full-year, representing 46% growth
compared to the full year of 2023.
“We are pleased with the performance of the Orthofix team to
serve our surgeons and patients and successfully execute our plans
throughout 2024,” said Massimo Calafiore, President and CEO. “Our
fourth quarter results reflect outstanding performance across all
three major product lines, providing further evidence that
Orthofix’s balanced and complementary product mix offers a
differentiated advantage across multiple markets. We enter 2025
with great momentum as two integrated organizations. The entire
team remains focused on executing our priorities, and I look
forward to leveraging our unique portfolio platform to drive value
creation through profitable growth in 2025 and beyond."
Financial Results Overview
Fourth Quarter 2024 Net Sales and Financial Results
The following table provides net sales by major product category
by reporting segment:
Three Months Ended December
31,
(Unaudited, U.S. Dollars, in
millions)
2024
2023
Change
Constant Currency
Change
Bone Growth Therapies
$
63.9
$
58.8
8.6
%
8.6
%
Spinal Implants, Biologics, and Enabling
Technologies
116.0
111.0
4.5
%
4.5
%
Global Spine
179.9
169.8
5.9
%
6.0
%
Global Orthopedics
35.8
30.6
16.8
%
18.1
%
Net sales
$
215.7
$
200.4
7.6
%
7.8
%
Gross margins were 69.0% for the quarter and were 71.1% on a
non-GAAP adjusted basis.
Net loss was $(29.1) million, or $(0.75) per share, compared to
net loss of $(22.2) million, or $(0.59) per share in the prior year
period. Non-GAAP adjusted EBITDA was $23.9 million, or 11.1% of net
sales, compared to non-GAAP adjusted EBITDA of $19.6 million, or
9.8% of net sales, in the prior year period.
Full-Year 2024 Net Sales and Financial Results
The following table provides net sales by major product category
by reporting segment:
Year Ended December
31,
(Unaudited, U.S. Dollars, in
millions)
2024
2023
Change
Constant Currency
Change
Bone Growth Therapies
$
233.4
$
212.5
9.8
%
9.8
%
Spinal Implants, Biologics, and Enabling
Technologies
441.9
418.8
5.5
%
5.5
%
Global Spine
675.3
631.3
7.0
%
7.0
%
Global Orthopedics
124.2
115.3
7.7
%
7.9
%
Net sales
$
799.5
$
746.6
7.1
%
7.1
%
Gross margins were 68.3% for the year and were 71.0% on a
non-GAAP adjusted basis.
Net loss was $(126.0) million, or $(3.30) per share, compared to
net loss of $(151.4) million, or $(4.12) per share in the prior
year period. Non-GAAP adjusted EBITDA was $67.4 million, or 8.4% of
net sales, compared to non-GAAP adjusted EBITDA of $46.3 million,
or 6.2% of net sales, in the prior year period.
Liquidity
Cash, cash equivalents, and restricted cash on December 31, 2024
totaled $85.7 million compared to $37.8 million on December 31,
2023.
M6 Artificial Disc Update
Consistent with Orthofix’s strategic focus on spinal fixation
and deformity correction, the Company has decided to discontinue
its M6-C™ artificial cervical disc and M6-L™ artificial lumbar disc
product lines and allocate associated resources and investment to
more profitable growth opportunities in those focus areas. Global
net sales for the M6-C artificial cervical and M6-L artificial
lumbar discs were $23.4 million in 2024. Orthofix intends to
fulfill all requirements related to post-market surveillance
activities and meet its obligations with respect to premarket
approval of M6 devices, including completion of the IDE study in
the United States.
Business Outlook
The Company is providing full-year 2025 guidance as follows:
- Net sales expected to range between $818 million to $826
million, excluding sales from the discontinued M6 artificial disc
product lines and including a negative impact from foreign currency
of approximately $4 million, or 50 basis points, on a reported
basis, as compared to the full-year 2024. The Company’s expected
net sales represent implied constant currency growth of 6.5%
year-over-year at the midpoint of the range. This guidance range is
based on the current foreign currency exchange rates and does not
take into account any additional potential exchange rate changes
that may occur this year.
- Non-GAAP adjusted EBITDA expected to be $82 million to $86
million. This range includes the anticipated impact from the
discontinuation of the M6 product lines.
- Positive free cash flow expected for full-year 2025, excluding
the impact of restructuring charges related to the discontinuation
of the M6-C artificial cervical and M6-L artificial lumbar disc
product lines.
- The Company is also increasing its long-term net sales CAGR
target to 6.5% to 7.5% from the previous net sales CAGR target of
6% to 7%, reflecting the discontinuation of the M6 artificial disc
product lines.
The Company will provide a full update on the accounting
treatment and financial impact for the discontinuation of the M6
product lines on its first quarter 2025 earnings call.
An investor presentation for the Company's fourth quarter and
full-year 2024 financial results is available in the "Events &
Presentations" section of the Orthofix investor relations website
at ir.orthofix.com.
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 December 31, 2024. Interested parties may access the
conference call by dialing (888) 596-4144 in the U.S., and (646)
968-2525 in all other locations, and referencing the access code
5184023. A webcast and replay of the conference call may be
accessed in the "Events & Presentations" section of the
Orthofix investor relations website at ir.orthofix.com.
Internet Posting of Information
Orthofix routinely posts information that may be important to
investors in the “Investor Relations” section of its website at
www.orthofix.com. The Company encourages investors and potential
investors to consult the Orthofix website regularly for important
information about Orthofix.
About Orthofix
Orthofix is a global medical technology company headquartered in
Lewisville, Texas. By providing medical technologies that heal
musculoskeletal pathologies, we deliver exceptional experiences and
life-changing solutions to patients around the world. Orthofix
offers a comprehensive portfolio of spinal hardware, bone growth
therapies, specialized orthopedic solutions, biologics and enabling
technologies, including the 7D FLASH™ navigation system. To learn
more, visit Orthofix.com and follow on LinkedIn.
Forward-Looking Statements
This communication contains forward-looking statements within
the meaning of Section 21E of the Securities Exchange Act of 1934,
as amended, and Section 27A of the Securities Act of 1933, as
amended, relating to our business and financial outlook, which are
based on our current beliefs, assumptions, intentions, plans,
expectations, estimates, forecasts and projections. In some cases,
you can identify forward-looking statements by terminology such as
“may,” “will,” “should,” “expects,” “plans,” “anticipates,”
“believes,” “estimates,” “projects,” “intends,” “predicts,”
“potential,” or “continue” or other comparable terminology.
Forward-looking statements in this communication include the
Company's expectations regarding net sales, adjusted EBITDA, and
free cash flow for the year ended December 31, 2025.
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, 2024.
Factors that could cause future results to differ from those
expressed by forward-looking statements include, but are not
limited to, (i) our ability to maintain operations to support our
customers and patients in the near-term and to capitalize on future
growth opportunities, (ii) risks associated with acceptance of
surgical products and procedures by surgeons and hospitals, (iii)
development and acceptance of new products or product enhancements,
(iv) clinical and statistical verification of the benefits achieved
via the use of our products, (v) our ability to adequately manage
inventory, (vi) our ability to recruit and retain management and
key personnel, (vii) our success in defending legal proceedings
brought against us, and (viii) the other risks and uncertainties
more fully described in our periodic filings with the Securities
and Exchange Commission (the “SEC”). As a result of these various
risks, our actual outcomes and results may differ materially from
those expressed in these forward-looking statements.
Further, any forward-looking statement speaks only as of the
date hereof, unless it is specifically otherwise stated to be made
as of a different date. We undertake no obligation to update, and
expressly disclaim any duty to update, our forward-looking
statements, whether as a result of circumstances or events that
arise after the date hereof, new information, or otherwise, except
as required by law.
The Company is unable to provide expectations of GAAP net income
(loss) before income taxes, the closest comparable GAAP measures to
adjusted EBITDA (which is a non-GAAP measure), on a forward-looking
basis because the Company is unable to predict, without
unreasonable efforts, the ultimate outcome of matters (including
acquisition-related expenses, accounting fair value adjustments,
and other such items) that will determine the quantitative amount
of the items excluded in calculating adjusted EBITDA, which items
are further described in the reconciliation tables and related
descriptions below. These items are uncertain, depend on various
factors, and could be material to the Company’s results computed in
accordance with GAAP.
ORTHOFIX MEDICAL INC.
Condensed Consolidated
Statements of Operations
Three Months Ended
Year Ended
December 31,
December 31,
(U.S. Dollars, in thousands, except
share and per share data)
2024
2023
2024
2023
(Unaudited)
Net sales
$
215,657
$
200,415
$
799,491
$
746,641
Cost of sales
66,816
63,785
253,606
260,368
Gross profit
148,841
136,630
545,885
486,273
Sales, general, and administrative
136,479
132,284
532,525
530,395
Research and development
18,807
18,941
73,643
80,231
Acquisition-related amortization and
remeasurement
5,031
3,720
24,336
14,757
Operating loss
(11,476
)
(18,315
)
(84,619
)
(139,110
)
Interest expense, net
(14,920
)
(4,500
)
(29,631
)
(8,631
)
Other income (expense), net
(3,315
)
766
(9,625
)
(938
)
Loss before income taxes
(29,711
)
(22,049
)
(123,875
)
(148,679
)
Income tax benefit (expense)
564
(125
)
(2,122
)
(2,716
)
Net loss
$
(29,147
)
$
(22,174
)
$
(125,997
)
$
(151,395
)
Net loss per common share:
Basic
$
(0.75
)
$
(0.59
)
$
(3.30
)
$
(4.12
)
Diluted
(0.75
)
(0.59
)
(3.30
)
(4.12
)
Weighted average number of common shares
(in millions):
Basic
38.7
37.3
38.1
36.7
Diluted
38.7
37.3
38.1
36.7
ORTHOFIX MEDICAL INC.
Condensed Consolidated Balance
Sheets
(U.S. Dollars, in thousands, except par
value data)
December 31, 2024
December 31, 2023
Assets
Current assets
Cash and cash equivalents
$
83,238
$
33,107
Restricted cash
2,500
4,650
Accounts receivable, net of allowances of
$7,418 and $7,130, respectively
134,713
128,098
Inventories
189,452
222,166
Prepaid expenses and other current
assets
23,382
32,422
Total current assets
433,285
420,443
Property, plant, and equipment, net
139,804
159,060
Intangible assets, net
98,803
117,490
Goodwill
194,934
194,934
Other long-term assets
26,468
33,388
Total assets
$
893,294
$
925,315
Liabilities and shareholders’
equity
Current liabilities
Accounts payable
$
48,803
$
58,357
Current portion of long-term debt
—
1,250
Current portion of finance lease
liability
755
708
Other current liabilities
119,070
104,908
Total current liabilities
168,628
165,223
Long-term debt
157,015
93,107
Long-term portion of finance lease
liability
17,835
18,532
Other long-term liabilities
46,692
49,723
Total liabilities
390,170
326,585
Contingencies
Shareholders’ equity
Common shares $0.10 par value; 100,000
shares authorized; 38,486 and 37,165 issued and outstanding as of
December 31, 2024 and 2023, respectively
3,849
3,717
Additional paid-in capital
779,718
746,450
Accumulated deficit
(276,141
)
(150,144
)
Accumulated other comprehensive loss
(4,302
)
(1,293
)
Total shareholders’ equity
503,124
598,730
Total liabilities and shareholders’
equity
$
893,294
$
925,315
ORTHOFIX MEDICAL INC.
Non-GAAP Financial Measures
The following tables present reconciliations of various
financial measures calculated in accordance with U.S. generally
accepted accounting principles (“GAAP”), to various non-GAAP
financial measures that exclude (or in the case of free cash flow,
include) items specified in the tables. The GAAP measures shown in
the tables below represent the most comparable GAAP measure to the
applicable non-GAAP measure(s) shown in the table. For further
information regarding the nature of these exclusions, why the
Company believes that these non-GAAP financial measures provide
useful information to investors, the specific manner in which
management uses these measures, and some of the limitations
associated with the use of these measures, please refer to the
Company's Current Report on Form 8-K regarding this press release
filed today with the SEC available on the SEC's website at
www.sec.gov and on the “Investors” page of the Company’s website at
www.orthofix.com.
Adjusted Gross Profit and Adjusted
Gross Margin
Three Months Ended December
31,
Year Ended December
31,
(Unaudited, U.S. Dollars, in
thousands)
2024
2023
2024
2023
Gross profit
$
148,841
$
136,630
$
545,885
$
486,273
Share-based compensation expense
477
462
2,068
1,878
SeaSpine merger-related costs
660
214
6,239
6,861
Strategic investments
32
125
192
389
Acquisition-related fair value
adjustments
3,047
7,037
12,188
36,044
Amortization/depreciation of acquired
long-lived assets
313
372
1,153
1,196
Medical device regulation
—
(72
)
—
604
Adjusted gross profit
$
153,370
$
144,768
$
567,725
$
533,245
Adjusted gross margin
71.1
%
72.2
%
71.0
%
71.4
%
Adjusted EBITDA
Three Months Ended December
31,
Year Ended December
31,
(Unaudited, U.S. Dollars, in
thousands)
2024
2023
2024
2023
Net loss
$
(29,147
)
$
(22,174
)
$
(125,997
)
$
(151,395
)
Income tax expense (benefit)
(564
)
125
2,122
2,716
Interest expense, net
14,920
4,500
29,631
8,631
Depreciation and amortization
15,994
13,969
60,061
53,063
Share-based compensation expense
7,165
3,167
32,455
35,707
Foreign exchange impact
3,133
(2,638
)
4,395
(1,581
)
SeaSpine merger-related costs
1,493
2,261
14,485
36,577
Strategic investments
440
389
910
2,272
Acquisition-related fair value
adjustments
3,737
6,486
19,088
33,393
(Gain) loss on investments
—
1,781
5,120
1,781
Litigation and investigation costs
5,452
8,842
15,770
14,453
Succession charges
1,315
1,006
9,376
1,176
Medical device regulation
—
1,927
—
9,492
Adjusted EBITDA
$
23,938
$
19,641
$
67,416
$
46,285
Adjusted EBITDA as % of net sales
11.1
%
9.8
%
8.4
%
6.2
%
Adjusted Net Income
Three Months Ended December
31,
Year Ended December
31,
(Unaudited, U.S. Dollars, in
thousands)
2024
2023
2024
2023
Net loss
$
(29,147
)
$
(22,174
)
$
(125,997
)
$
(151,395
)
Share-based compensation expense
7,165
3,167
32,455
35,707
Foreign exchange impact
3,132
(2,637
)
4,395
(1,581
)
SeaSpine merger-related costs
4,430
2,029
17,864
37,609
Strategic investments
470
405
1,036
2,037
Acquisition-related fair value
adjustments
3,737
6,486
19,088
33,393
Amortization/depreciation of acquired
long-lived assets
4,837
5,023
19,323
19,994
Litigation and investigation costs
5,452
8,842
15,770
14,453
Succession charges
1,315
1,007
9,376
1,176
Medical device regulation
—
1,954
—
9,493
Interest and loss on investments
—
1,759
5,070
2,098
Long-term income tax rate adjustment
(796
)
(1,551
)
1,981
1,120
Adjusted net income
$
595
$
4,310
$
361
$
4,104
Cash Flow and Free Cash Flow
Year Ended December
31,
(U.S. Dollars, in thousands)
2024
2023
Net cash provided by (used in) operating
activities
$
25,790
$
(45,753
)
Net cash used in investing activities
(27,580
)
(33,131
)
Net cash provided by financing
activities
50,709
65,322
Effect of exchange rate changes on
cash
(938
)
619
Net change in cash, cash equivalents, and
restricted cash
$
47,981
$
(12,943
)
Year Ended December
31,
(Unaudited, U.S. Dollars, in
thousands)
2024
2023
Net cash from operating activities
$
25,790
$
(45,753
)
Capital expenditures
(34,876
)
(62,050
)
Free cash flow
$
(9,086
)
$
(107,803
)
Reconciliation of Non-GAAP Financial
Measures to Reported Operating Expenses
Three Months Ended December
31,
Year Ended December
31,
(Unaudited, U.S. Dollars, in
thousands)
2024
2023
2024
2023
Sales, general, and
administrative
$
136,479
$
132,284
$
532,525
$
530,395
Reconciling items impacting sales,
general, and administrative:
Strategic investments
(4,073
)
(1,808
)
(11,674
)
(28,523
)
Amortization/depreciation of acquired
long-lived assets
(183
)
(381
)
(734
)
(1,393
)
Litigation and investigation costs
(5,451
)
(8,842
)
(15,769
)
(14,453
)
Succession charges
(160
)
(1,007
)
(8,221
)
(1,176
)
Medical device regulation
—
—
—
(11
)
Sales, general, and administrative
expense, as adjusted
$
126,612
$
120,246
$
496,127
$
484,839
Sales, general, and administrative expense
as a percentage of net sales, as adjusted
58.7
%
60.0
%
62.1
%
64.9
%
Three Months Ended December
31,
Year Ended December
31,
(Unaudited, U.S. Dollars, in
thousands)
2024
2023
2024
2023
Research and development expense, as
reported
$
18,807
$
18,941
$
73,643
$
80,231
Reconciling items impacting research and
development:
Strategic investments
(135
)
(331
)
(780
)
(3,061
)
Medical device regulation
—
(2,029
)
—
(8,883
)
Succession charges
(1,155
)
—
(1,155
)
-
Research and development expense, as
adjusted
$
17,517
$
16,581
$
71,708
$
68,287
Research and development expense as a
percentage of net sales, as adjusted
8.1
%
8.3
%
9.0
%
9.1
%
Reconciliations of Non-GAAP Financial
Measures to Reported Non-Operating (Income) Expense
Three Months Ended December
31,
Year Ended December
31,
(Unaudited, U.S. Dollars, in
thousands)
2024
2023
2024
2023
Non-operating expense
$
18,235
$
3,734
$
39,256
$
9,569
Reconciling items impacting non-operating
expense:
Foreign exchange impact
(3,133
)
2,637
(4,396
)
1,580
Strategic investments
—
19
—
(876
)
Interest and loss on investments
—
(1,759
)
(5,070
)
(2,098
)
Non-operating expense, as
adjusted
$
15,102
$
4,631
$
29,790
$
8,175
Non-operating expense as a percentage of
net sales, as adjusted
7.0
%
2.3
%
3.7
%
1.1
%
View source
version on businesswire.com: https://www.businesswire.com/news/home/20250225486621/en/
Investors and Media Julie Dewey, IRC Chief Investor
Relations & Communications Officer JulieDewey@Orthofix.com
209.613.6945
Orthofix Medical (NASDAQ:OFIX)
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