Building on Positive Momentum from
Compelling Combination of Profitable, Above-Market Growth with a
Stronger Financial Profile
Orthofix Medical Inc. (NASDAQ:OFIX), a leading global medical
technology company, today reported its financial results for the
third quarter ended September 30, 2024, reiterated its full-year
2024 financial guidance, and introduced new three-year financial
targets.
Recent Highlights
- Third quarter 2024 net sales of $196.6 million, an increase
of 7% on a reported and constant currency basis compared to third
quarter 2023
- U.S. Spine Fixation1 net sales growth of 18% compared to
third quarter 2023, driven by distribution expansion and further
penetration in existing accounts
- Bone Growth Therapies (BGT) net sales growth of 9% and BGT
Fracture net sales growth of 13% compared to third quarter
2023
- U.S. Orthopedics delivered a record net sales quarter with
net sales growth of 15% compared to third quarter of 2023
- Company entered into record number of 7D FLASH™ Navigation
System earnout agreements and matched record for highest number of
7D placements in any quarter to date
- Third quarter 2024 net loss of $(27.4) million; Non-GAAP
adjusted EBITDA of $19.2 million, an increase of $5.7 million, with
adjusted EBITDA margin expanding approximately 250 basis points
compared to third quarter 2023
- Achieves free cash flow of $5.9 million in third quarter
2024, a significant improvement in cash usage compared to previous
quarters
- Announces new $275 million credit facility that replaces
existing financing and further optimizes the Company's capital
structure to support long-term profitable growth
- Maintains full-year 2024 net sales guidance of $795 million
to $800 million and full-year 2024 non-GAAP adjusted EBITDA
guidance of $64 million to $69 million; continue to expect positive
free cash flow for the second half of 2024
- Introduces new 2027 financial targets to increase
transparency and maximize value creation
Third quarter net sales were $196.6 million, an increase of 7%
on a reported and constant currency basis. Net loss was $(27.4)
million and earnings per share ("EPS") was $(0.71) on a reported
basis, representing an improvement of 8% when compared to the prior
year period. Non-GAAP adjusted EBITDA was $19.2 million for the
third quarter, an increase of $5.7 million, representing adjusted
EBITDA margin expansion of approximately 250 basis points over the
prior year period.
“Our third quarter net sales results were driven by focused
execution of our key growth priorities, and we also delivered
strong adjusted EBITDA margin expansion and positive free cash
flow, all of which we believe keeps us on a clear course to achieve
our 2024 and long-term financial targets,” said Massimo Calafiore,
President and Chief Executive Officer. “Highlights in the quarter
included year-over-year revenue growth across each of our business
segments where our performance once again was led by strength in
our U.S. markets, including U.S. Spine Fixation, which grew 18%,
and Bone Growth Therapies, which grew 9% overall and 13% in
Fracture, further highlighting the benefit of cross-selling in our
integrated spine channel. Notably, our U.S. Orthopedics business
delivered a record net sales quarter and grew 15% year-over-year,
benefiting from strong commercial execution. In addition to
reiterating our full-year 2024 financial guidance, we are also
introducing our new 2027 financial targets, which reflect our
confidence in sustainable growth trends, the strength of our
differentiated and expanding product portfolio, which continues to
win share, and our commercial strategy and execution. We are
well-positioned to accelerate our positive momentum and deliver on
our commitment to drive disciplined, profitable growth and
innovation while increasing long-term shareholder value.”
Financial Results Overview
Third Quarter 2024 Net Sales and Financial Results
The following table provides net sales by major product category
by reporting segment:
Three Months Ended September
30,
(Unaudited, U.S. Dollars, in
millions)
2024
2023
Change
Constant Currency
Change
Bone Growth Therapies
$
57.9
$
53.4
8.6
%
8.6
%
Spinal Implants, Biologics and Enabling
Technologies
108.2
101.0
7.1
%
7.1
%
Global Spine
166.1
154.4
7.6
%
7.6
%
Global Orthopedics
30.5
29.7
2.9
%
2.5
%
Net sales
$
196.6
$
184.0
6.8
%
6.8
%
Gross margins were 68.7% for the quarter and were 71.3% on a
non-GAAP adjusted basis.
Net loss was $(27.4) million, or $(0.71) per share, compared to
net loss of $(28.9) million, or $(0.77) per share in the prior year
period. Non-GAAP adjusted EBITDA was $19.2 million, or 9.8% of net
sales, compared to non-GAAP adjusted EBITDA of $13.5 million, or
7.3% of net sales, in the prior year period.
Liquidity
Cash, cash equivalents, and restricted cash on September 30,
2024, totaled $32.6 million compared to $28.9 million on June 30,
2024.
Orthofix Announces New Three-Year Financial Targets
The Company is providing new three-year financial targets for
2025 through 2027:
- 6% to 7% net sales CAGR from 2025 through 2027
- Mid-teens non-GAAP adjusted EBITDA as a percent of net sales
for the full-year 2027
- Positive free cash flow generation from 2025 through 2027
Calafiore concluded, “With a compelling combination of
profitable, above-market growth and a stronger financial profile, I
believe our focused commercial strategy and broad, differentiated
technologies, combined with a robust innovation pipeline and our
pace-setting, enabling technologies position us well to achieve
these targets and deliver increased value to our shareholders.”
Business Outlook
The Company is reiterating its 2024 full-year guidance as
follows:
- Net sales are expected to range between $795 million to $800
million, representing implied growth of 6.6% to 7.2% year-over year
on a constant currency basis. These expectations are based on the
current foreign currency exchange rates and do not take into
account any additional potential exchange rate changes that may
occur this year.
- Non-GAAP adjusted EBITDA is expected to range from $64 million
to $69 million.
- The Company expects to continue to be free cash flow positive
for the remainder of 2024.
These guidance ranges do not contemplate any potential impact to
elective procedures as a result of IV fluid shortages or other
hurricane-related effects.
An investor presentation for the Company's third quarter 2024
financial results, corporate strategy and new three-year financial
targets is available in the "Investors" section of Orthofix's
website at https://ir.orthofix.com/events-and-presentations.
Conference Call
Orthofix will host a conference call today at 8:30 AM Eastern
time to discuss the Company's financial results for the quarter
ended September 30, 2024. Interested parties may access the
conference call by dialing (888) 330-2508 in the U.S., and (240)
789-2735 in all other locations, and referencing the access code
9556380. A replay of the call will be available for three weeks by
dialing (800) 770-2030 in the U.S., and (647) 362-9199 in all other
locations, and entering the access code 9556380. A webcast of the
conference call may be accessed at ir.Orthofix.com.
About Orthofix
Orthofix is a global medical technology company headquartered in
Lewisville, Texas. By providing medical technologies that heal
musculoskeletal pathologies, we deliver exceptional experiences and
life-changing solutions to patients around the world. Orthofix
offers a comprehensive portfolio of spinal hardware, bone growth
therapies, specialized orthopedic solutions, biologics and enabling
technologies, including the 7D FLASH™ navigation system. To learn
more, visit Orthofix.com and follow on LinkedIn.
Forward-Looking Statements
This communication contains forward-looking statements within
the meaning of Section 21E of the Securities Exchange Act of 1934,
as amended, and Section 27A of the Securities Act of 1933, as
amended, relating to our business and financial outlook, which are
based on our current beliefs, assumptions, intentions, plans,
expectations, estimates, forecasts and projections. In some cases,
you can identify forward-looking statements by terminology such as
“may,” “will,” “should,” “expects,” “plans,” “anticipates,”
“believes,” “estimates,” “projects,” “intends,” “predicts,”
“potential,” or “continue” or other comparable terminology.
Forward-looking statements in this communication include the
Company's expectations regarding net sales, adjusted EBITDA, and
free cash flow for the year ended December 31, 2024, and its
three-year financial targets for 2025 through 2027. Forward-looking
statements are not guarantees of our future performance, are based
on our current expectations and assumptions regarding our business,
the economy and other future conditions, and are subject to risks,
uncertainties and changes in circumstances that are difficult to
predict, including the risks described in Part I, Item 1A under the
heading Risk Factors in our Annual Report on Form 10-K for the year
ended December 31, 2023 (the “2023 Form 10-K”), and in Part II,
Item 1A under the heading Risk Factors in our Quarterly Report on
Form 10-Q for the quarter ended September 30, 2024. Factors that
could cause future results to differ from those expressed by
forward-looking statements include, but are not limited to, (i) our
ability to maintain operations to support our customers and
patients in the near-term and to capitalize on future growth
opportunities, (ii) risks associated with acceptance of surgical
products and procedures by surgeons and hospitals, (iii)
development and acceptance of new products or product enhancements,
(iv) clinical and statistical verification of the benefits achieved
via the use of our products, (v) our ability to adequately manage
inventory, (vi) our ability to recruit and retain management and
key personnel, (vii) our success in defending legal proceedings
brought against us, and (viii) the other risks and uncertainties
more fully described in our periodic filings with the Securities
and Exchange Commission (the “SEC”). As a result of these various
risks, our actual outcomes and results may differ materially from
those expressed in these forward-looking statements.
Further, any forward-looking statement speaks only as of the
date hereof, unless it is specifically otherwise stated to be made
as of a different date. We undertake no obligation to update, and
expressly disclaim any duty to update, our forward-looking
statements, whether as a result of circumstances or events that
arise after the date hereof, new information, or otherwise, except
as required by law.
The Company is unable to provide expectations of GAAP income
(loss) before income taxes, the closest comparable GAAP measures to
adjusted EBITDA (which is a non-GAAP measure), on a forward-looking
basis because the Company is unable to predict, without
unreasonable efforts, the ultimate outcome of matters (including
acquisition-related expenses, accounting fair value adjustments,
and other such items) that will determine the quantitative amount
of the items excluded in calculating adjusted EBITDA, which items
are further described in the reconciliation tables and related
descriptions below. These items are uncertain, depend on various
factors, and could be material to the Company’s results computed in
accordance with GAAP.
ORTHOFIX MEDICAL INC.
Condensed Consolidated
Statements of Operations
Three Months Ended
Nine Months Ended
September 30,
September 30,
(Unaudited, U.S. Dollars, in thousands,
except share and per share data)
2024
2023
2024
2023
Net sales
$
196,606
$
184,006
$
583,834
$
546,226
Cost of sales
61,553
64,243
186,790
196,583
Gross profit
135,053
119,763
397,044
349,643
Sales and marketing
96,576
94,947
296,843
287,987
General and administrative
33,561
27,136
99,203
110,124
Research and development
17,294
18,559
54,835
61,290
Acquisition-related amortization and
remeasurement
6,521
3,570
19,305
11,037
Operating loss
(18,899
)
(24,449
)
(73,142
)
(120,795
)
Interest expense, net
(5,210
)
(1,576
)
(14,711
)
(4,131
)
Other expense, net
(2,528
)
(2,360
)
(6,312
)
(1,704
)
Loss before income taxes
(26,637
)
(28,385
)
(94,165
)
(126,630
)
Income tax expense
(751
)
(472
)
(2,686
)
(2,591
)
Net loss
$
(27,388
)
$
(28,857
)
$
(96,851
)
$
(129,221
)
Net loss per common share:
Basic
$
(0.71
)
$
(0.77
)
$
(2.55
)
$
(3.53
)
Diluted
(0.71
)
(0.77
)
(2.55
)
(3.53
)
Weighted average number of common shares
(in millions):
Basic
38.5
37.2
37.9
36.6
Diluted
38.5
37.2
37.9
36.6
ORTHOFIX MEDICAL INC.
Condensed Consolidated Balance
Sheets
(U.S. Dollars, in thousands, except par
value data)
September 30, 2024
December 31, 2023
(Unaudited)
Assets
Current assets
Cash and cash equivalents
$
30,054
$
33,107
Restricted Cash
2,500
4,650
Accounts receivable, net of allowances of
$7,878 and $7,130, respectively
124,845
128,098
Inventories
205,812
222,166
Prepaid expenses and other current
assets
23,003
32,422
Total current assets
386,214
420,443
Property, plant, and equipment, net
146,685
159,060
Intangible assets, net
104,546
117,490
Goodwill
194,934
194,934
Other long-term assets
35,493
33,388
Total assets
$
867,872
$
925,315
Liabilities and shareholders’
equity
Current liabilities
Accounts payable
$
47,060
$
58,357
Current portion of long-term debt
6,250
1,250
Current portion of finance lease
liability
743
708
Other current liabilities
107,845
104,908
Total current liabilities
161,898
165,223
Long-term debt
112,215
93,107
Long-term portion of finance lease
liability
18,027
18,532
Other long-term liabilities
49,808
49,723
Total liabilities
341,948
326,585
Contingencies
Shareholders’ equity
Common shares $0.10 par value; 100,000
shares authorized; 38,209 and 37,165 issued and outstanding as of
September 30, 2024, and December 31, 2023, respectively
3,821
3,717
Additional paid-in capital
770,000
746,450
Accumulated deficit
(246,995
)
(150,144
)
Accumulated other comprehensive loss
(902
)
(1,293
)
Total shareholders’ equity
525,924
598,730
Total liabilities and shareholders’
equity
$
867,872
$
925,315
ORTHOFIX MEDICAL INC.
Non-GAAP Financial Measures
The following tables present reconciliations of various
financial measures calculated in accordance with U.S. generally
accepted accounting principles (“GAAP”), to various non-GAAP
financial measures that exclude (or in the case of free cash flow,
include) items specified in the tables. The GAAP measures shown in
the tables below represent the most comparable GAAP measure to the
applicable non-GAAP measure(s) shown in the table. For further
information regarding the nature of these exclusions, why the
Company believes that these non-GAAP financial measures provide
useful information to investors, the specific manner in which
management uses these measures, and some of the limitations
associated with the use of these measures, please refer to the
Company's Current Report on Form 8-K regarding this press release
filed today with the SEC available on the SEC's website at
www.sec.gov and on the “Investors” page of the Company’s website at
www.orthofix.com.
Adjusted Gross Profit and Adjusted
Gross Margin
Three Months Ended September
30,
Nine Months Ended September
30,
(Unaudited, U.S. Dollars, in
thousands)
2024
2023
2024
2023
Gross profit
$
135,053
$
119,763
$
397,044
$
349,643
Share-based compensation expense
557
463
1,591
1,416
SeaSpine merger-related costs
1,161
2,161
5,579
6,647
Strategic investments
32
55
160
264
Acquisition-related fair value
adjustments
3,047
7,922
9,141
29,007
Amortization/depreciation of acquired
long-lived assets
313
280
840
824
Medical device regulation
—
6
—
676
Adjusted gross profit
$
140,163
$
130,650
$
414,355
$
388,477
Adjusted gross margin
71.3
%
71.0
%
71.0
%
71.1
%
Adjusted EBITDA
Three Months Ended September
30,
Nine Months Ended September
30,
(Unaudited, U.S. Dollars, in
thousands)
2024
2023
2024
2023
Net loss
$
(27,388
)
$
(28,857
)
$
(96,851
)
$
(129,221
)
Income tax expense (benefit)
751
472
2,686
2,591
Interest expense, net
5,210
1,576
14,711
4,131
Depreciation and amortization
15,173
13,097
44,067
39,094
Share-based compensation expense
6,531
6,274
25,290
32,540
Foreign exchange impact
(1,176
)
1,909
1,263
1,057
SeaSpine merger-related costs
2,616
5,416
12,992
34,362
Strategic investments
39
484
470
1,454
Acquisition-related fair value
adjustments
5,017
7,122
15,351
26,907
Interest and loss on investments
3,567
429
5,120
429
Litigation and investigation costs
8,335
3,851
10,318
5,611
Succession charges
505
(92
)
8,061
170
Medical device regulation
—
1,840
—
7,519
Adjusted EBITDA
$
19,180
$
13,521
$
43,478
$
26,644
Adjusted EBITDA as a percentage of net
sales
9.8
%
7.3
%
7.4
%
4.9
%
Adjusted Net Income
Three Months Ended September
30,
Nine Months Ended September
30,
(Unaudited, U.S. Dollars, in
thousands)
2024
2023
2024
2023
Net loss
$
(27,388
)
$
(28,857
)
$
(96,851
)
$
(129,221
)
Share-based compensation expense
6,531
6,274
25,290
32,540
Foreign exchange impact
(1,176
)
1,909
1,263
1,057
SeaSpine merger-related costs
2,619
5,247
13,434
35,600
Strategic investments
69
525
566
1,631
Acquisition-related fair value
adjustments
5,017
7,122
15,351
26,907
Amortization/depreciation of acquired
long-lived assets
5,046
5,026
14,486
14,970
Litigation and investigation costs
8,335
3,851
10,318
5,611
Succession charges
505
(94
)
8,061
168
Medical device regulation
—
1,842
—
7,531
Interest and loss on investments
3,567
399
5,071
339
Long-term income tax rate adjustment
(335
)
(569
)
2,777
2,669
Adjusted net income (loss)
$
2,790
$
2,675
$
(234
)
$
(198
)
Cash Flow and Free Cash Flow
Nine Months Ended September
30,
(Unaudited, U.S. Dollars, in
thousands)
2024
2023
Net cash from operating activities
$
2,060
$
(39,059
)
Net cash from investing activities
(26,445
)
(18,078
)
Net cash from financing activities
19,222
40,042
Effect of exchange rate changes on
cash
(40
)
58
Net change in cash and cash
equivalents
$
(5,203
)
$
(17,037
)
Nine Months Ended September
30,
(Unaudited, U.S. Dollars, in
thousands)
2024
2023
Net cash from operating activities
$
2,060
$
(39,059
)
Capital expenditures
(26,345
)
(46,997
)
Free cash flow
$
(24,285
)
$
(86,056
)
Reconciliation of Non-GAAP Financial
Measures to Reported Operating Expenses
Three Months Ended September
30,
Nine Months Ended September
30,
(Unaudited, U.S. Dollars, in
thousands)
2024
2023
2024
2023
Sales and marketing expense, as
reported
$
96,576
$
94,947
$
296,843
$
287,987
Reconciling items impacting sales and
marketing:
Strategic investments
65
(1,680
)
(3,347
)
(5,201
)
Litigation and investigation costs
377
—
377
(857
)
Medical device regulation
—
(6
)
—
(11
)
Amortization/depreciation of acquired
long-lived assets
(178
)
(178
)
(475
)
(475
)
Sales and marketing expense, as
adjusted
$
96,840
$
93,083
$
293,398
$
281,443
Sales and marketing expense as a
percentage of net sales, as adjusted
49.3
%
50.6
%
50.3
%
51.5
%
Three Months Ended September
30,
Nine Months Ended September
30,
(Unaudited, U.S. Dollars, in
thousands)
2024
2023
2024
2023
General and administrative expense, as
reported
$
33,561
$
27,136
$
99,203
$
110,124
Reconciling items impacting general and
administrative:
Strategic investments
(1,420
)
(1,522
)
(4,254
)
(21,514
)
Amortization/depreciation of acquired
long-lived assets
(4
)
(201
)
(76
)
(537
)
Litigation and investigation costs
(8,712
)
(3,852
)
(10,695
)
(4,754
)
Succession charges
(505
)
93
(8,061
)
(169
)
General and administrative expense, as
adjusted
$
22,920
$
21,654
$
76,117
$
83,150
General and administrative expense as a
percentage of net sales, as adjusted
11.7
%
11.8
%
13.0
%
15.2
%
Three Months Ended September
30,
Nine Months Ended September
30,
(Unaudited, U.S. Dollars, in
thousands)
2024
2023
2024
2023
Research and development expense, as
reported
$
17,294
$
18,559
$
54,835
$
61,290
Reconciling items impacting research and
development:
Strategic investments
(69
)
(356
)
(645
)
(2,730
)
Medical device regulation
—
(1,837
)
—
(6,854
)
Research and development expense, as
adjusted
$
17,225
$
16,366
$
54,190
$
51,706
Research and development expense as a
percentage of net sales, as adjusted
8.8
%
8.9
%
9.3
%
9.5
%
Reconciliation of Non-GAAP Financial Measures to Reported
Non-Operating (Income) Expense
Three Months Ended September
30,
Nine Months Ended September
30,
(Unaudited, U.S. Dollars, in
thousands)
2024
2023
2024
2023
Non-operating expense
$
7,738
$
3,936
$
21,023
$
5,835
Reconciling items impacting non-operating
expense:
Foreign exchange impact
1,176
(1,909
)
(1,263
)
(1,057
)
Strategic investments
—
—
—
(895
)
Interest and loss on investments
(3,566
)
(399
)
(5,070
)
(339
)
Non-operating expense, as
adjusted
$
5,348
$
1,628
$
14,690
$
3,544
Non-operating expense as a percentage of
net sales, as adjusted
2.7
%
0.9
%
2.5
%
0.6
%
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241107805269/en/
Investor Relations Julie Dewey, Chief Investor Relations
and Communications Officer JulieDewey@Orthofix.com (209) 613-6945
Media Relations Denise Landry, Vice President, Global
Corporate Communications DeniseLandry@Orthofix.com (214)
937-2529
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