11/07/2024 | Press release | Distributed by Public on 11/07/2024 06:09
Orthofix Reports Third Quarter 2024 Results, Reiterates Full-Year 2024 Financial Guidance, and
Introduces New Three-Year Financial Targets
Building on Positive Momentum from Compelling Combination of Profitable, Above-Market Growth with a Stronger Financial Profile
LEWISVILLE, Texas - November 7, 2024 - 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 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
1 Spine Fixation is comprised of the Company's Spinal Implants product category, excluding motion preservation product offerings
1
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 |
||||
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:
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:
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.
2
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.
3
Company Contacts |
Investor Relations |
Julie Dewey, Chief Investor Relations and Communications Officer |
(209) 613-6945 |
Media Relations |
Denise Landry, Vice President, Global Corporate Communications |
(214) 937-2529 |
4
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 |
5
ORTHOFIX MEDICAL INC.
Condensed Consolidated Balance Sheets
(U.S. Dollars, in thousands, except par value data) |
September 30, |
December 31, |
||
(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; |
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 |
6
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 |
% |
7
Adjusted Net Income
Three Months Ended |
Nine Months Ended |
|||||||||||
(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 |
% |
8
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 |
% |
Source
Orthofix Medical Inc.
###
9