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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): March 6, 2025
XTANT
MEDICAL HOLDINGS, INC.
(Exact
name of registrant as specified in its charter)
| Delaware |
|
001-34951 |
|
20-5313323 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
664
Cruiser Lane
Belgrade,
Montana |
|
59714 |
| (Address
of principal executive offices) |
|
(Zip
Code) |
(406)
388-0480
(Registrant’s
telephone number, including area code)
Not
Applicable
(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, par value $0.000001 per share |
|
XTNT |
|
NYSE
American LLC |
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
March 6, 2025, Xtant Medical Holdings, Inc. (the “Company”) announced its financial results for the three months and year
ended December 31, 2024. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to
this Current Report on Form 8-K.
The
information in Item 2.02 of this report (including Exhibit 99.1) shall not be deemed “filed” for 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,
nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except
as expressly provided by specific reference in such a filing.
To
supplement its consolidated financial statements prepared in accordance with United States generally accepted accounting principles (“GAAP”),
the Company uses certain non-GAAP financial measures, such as non-GAAP adjusted EBITDA, which are included in the press release furnished
as Exhibit 99.1 to this report. The Company defines non-GAAP adjusted EBITDA as net income/loss from operations before depreciation,
amortization and interest expense, and provision for income tax/benefit, and as further adjusted to add back in or exclude, as applicable,
separation related expenses, legal settlements, non-cash compensation, acquisition-related expense, acquisition-related fair value adjustments,
gain on bargain purchase, and unrealized foreign currency translation gain or loss.
The
Company uses non-GAAP adjusted EBITDA in making operating decisions because it believes this measure provides meaningful supplemental
information regarding its core operational performance. Additionally, this measure gives the Company a better understanding of how it
should invest in sales and marketing and research and development activities and how it should allocate resources to both ongoing and
prospective business initiatives. The Company also uses non-GAAP adjusted EBITDA to help make budgeting and spending decisions, for example,
among sales and marketing expenses, general and administrative expenses, and research and development expenses. Additionally, the Company
believes its use of non-GAAP adjusted EBITDA facilitates management’s internal comparisons to historical operating results by factoring
out potential differences caused by charges not related to its regular, ongoing business, including, without limitation, non-cash charges
and certain large and unpredictable charges.
As
described above, the Company excludes the following items from non-GAAP adjusted EBITDA for the following reasons:
Separation
related expenses. The Company excludes separation related expenses primarily because such expenses are not reflective of the Company’s
ongoing operating results and are not used by management to assess the core profitability of the Company’s business operations.
The Company further believes that excluding this item from its non-GAAP results is useful to investors in that it allows for period over-period
comparability.
Legal
settlements. The Company excludes legal settlements primarily because such expenses are not reflective of the Company’s ongoing
operating results and are not used by management to assess the core profitability of the Company’s business operations. The Company
further believes that excluding this item from its non-GAAP results is useful to investors in that it allows for period-over-period comparability.
Non-cash
compensation. The Company excludes non-cash compensation, which is a non-cash charge related to equity awards granted by the Company.
Although non-cash compensation is a recurring charge to the Company’s operations, management has excluded it because it relies
on valuations based on future events, such as the market price of the Company’s common stock, that are difficult to predict and
are affected by market factors that are largely not within the control of the Company. Thus, management believes that excluding non-cash
compensation facilitates comparisons of the Company’s operational performance in different periods, as well as with similarly determined
non-GAAP financial measures of comparable companies.
Acquisition-related
expense. The Company excludes expenses directly related to the Company’s acquisitions and integration into the Company from
non-GAAP adjusted EBITDA primarily because such expenses are not reflective of the Company’s ongoing operating results and are
not used by management to assess the core profitability of the Company’s business operations. These expenses include legal and
accounting fees and transition related services and are not considered normal, recurring, cash operating expenses necessary to operate
the Company’s business. The Company further believes that excluding this item from its non-GAAP results is useful to investors
in that it allows for period-over-period comparability.
Acquisition-related
fair value adjustments. The Company excludes acquisition-related fair value adjustments from non-GAAP adjusted EBITDA primarily because
such adjustments are not reflective of the Company’s ongoing operating results and are not used by management to assess the core
profitability of the Company’s business operations. The Company further believes that excluding this item from its non-GAAP results
is useful to investors in that it allows for period-over-period comparability.
Gain
on bargain purchase. The Company excludes gain on bargain purchase primarily because this gain is not reflective of the Company’s
ongoing operating results and is not used by management to assess the core profitability of the Company’s business operations.
The Company further believes that excluding this item from its non-GAAP results is useful to investors in that it allows for period-over-period
comparability.
Unrealized
foreign currency translation gain or loss. The Company excludes unrealized foreign currency translation gain or loss, as applicable,
from non-GAAP adjusted EBITDA primarily because such gain or loss is not reflective of the Company’s ongoing operating results
and is not used by management to assess the core profitability of the Company’s business operations. The Company further believes
that excluding this item from its non-GAAP results is useful to investors in that it allows for period-over-period comparability.
Non-GAAP
adjusted EBITDA is reconciled to net loss, the most directly comparable GAAP measure in the press release.
Non-GAAP
financial measures are not in accordance with, or an alternative for, GAAP measures and may be different from non-GAAP financial measures
used by other companies. In addition, non-GAAP financial measures are not based on any comprehensive or standard set of accounting rules
or principles. Accordingly, the calculation of the Company’s non-GAAP financial measures may differ from the definitions of other
companies using the same or similar names, limiting, to some extent, the usefulness of such measures for comparison purposes. Non-GAAP
financial measures have limitations in that they do not reflect all of the amounts associated with the Company’s financial results
as determined in accordance with GAAP. Non-GAAP financial measures should only be used to evaluate the Company’s financial results
in conjunction with the corresponding GAAP measures. Accordingly, the Company qualifies its use of non-GAAP financial information in
a statement when non-GAAP financial information is presented.
| Item
9.01 | Financial
Statements and Exhibits. |
(d)
Exhibits.
SIGNATURE
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.
| |
XTANT MEDICAL HOLDINGS, INC. |
| |
|
|
| |
By: |
/s/ Scott Neils |
| |
|
Scott Neils |
| |
|
Chief Financial Officer |
Date:
March 6, 2025
Exhibit 99.1
Xtant Medical Reports Fourth Quarter and Full Year
2024 Financial Results
Full Year 2024 Revenue Growth of 28%
Expects 2025 Revenue of $126 Million to $130 Million
Without Need for Additional Capital
BELGRADE, Mont., March 6, 2025 — Xtant Medical
Holdings, Inc. (NYSE American: XTNT), a global medical technology company focused on surgical solutions for the treatment of spinal
disorders, today reported financial and operating results for the fourth quarter and year ended December 31, 2024 and provided full year
revenue guidance for 2025.
Fourth Quarter 2024 Financial Highlights
| |
● |
Revenue of $31.5 million, up 12%, compared to the prior year quarter |
| |
● |
Gross margin of 50.8% compared to 61.0% for the prior year quarter |
| |
● |
Net loss of $3.2 million compared to a net loss of $4.3 million in the prior year quarter |
| |
● |
Adjusted EBITDA of $438,000 compared to Adjusted EBITDA loss of $695,000 in the prior year quarter |
Full Year 2024 Financial Highlights
| |
● |
Revenue of $117.3 million, up 28%, compared to the prior year |
| |
● |
Gross margin of 58.2% compared to 60.8% for the prior year |
| |
● |
Net loss of $16.4 million compared to net income of $660,000 in the prior year, which included a $11.7 million bargain purchase gain related to the acquisition of Surgalign Holdings |
| |
● |
Adjusted EBITDA loss of $2.3 million compared to an Adjusted EBITDA loss of $1.4 million in the prior year |
Recent Business Highlights
| |
● |
Subsequent to year end, in the first quarter of 2025, entered into a two-year manufacture and license agreement with automatic renewals with a distributor granting the right to manufacture and supply Xtant’s SimpliGraft® product that provides for an upfront payment of $1.5 million and minimum purchase obligations |
| |
● |
Reduced operating expenses by more than $5 million on an annualized basis since third quarter of 2024. A portion of the savings will be reinvested to drive future growth. |
Sean Browne, President and
CEO of Xtant Medical, stated, “2024 was a year of significant accomplishments. We delivered total revenue of $117.3 million, representing
growth of 28% and in-line with our guidance, launched multiple new offerings and began capturing the operational and financial benefits
of internally producing our own products. Fourth quarter 2024 revenue growth was 12% year-over-year, and importantly, it was all organic
growth.”
Browne continued, “The work we completed in
2024 to streamline our product portfolio and increase reliance on our own supply chain has enhanced product quality, reduced costs and,
importantly, strengthened our business for sustainable, profitable growth. During the course of the fourth quarter of 2024, we identified
over $5 million of expenses for removal, which will benefit our 2025 financial position. Most of these cost reductions were tied to the
integration of the Surgalign business into Xtant.”
Brown concluded, “Today, we are providing full
year 2025 revenue guidance of $126 million to $130 million. Notably, we expect to begin generating free cash flow in the second half of
2025, enabling us to support our expected organic growth without the need for additional external capital.”
Fourth Quarter and Full Year 2024 Financial Results
Fourth quarter 2024 revenue grew 12% to $31.5 million,
compared to $28.1 million for the same quarter in 2023. Full year 2024 revenue grew 28% to $117.3 million, compared to $91.3 million for
2023. The revenue increase compared to the prior year quarter is due primarily to growth within our biologics product family and upfront
revenue generated from a licensing agreement. The year- over-year revenue increase also included additional sales resulting from the acquisition
of the Surgalign Holdings’ hardware and biologics business.
Gross margin for the fourth quarter of 2024 was 50.8%,
compared to 61.0% for the same period in 2023 and 58.2% for the full year 2024, compared to 60.8% for the full year 2023. These decreases
were primarily attributable to reduced production throughput and charges for the write-off of inventory associated with the acquisition
of Surgalign Holdings’ hardware and biologics business.
Operating expenses for the fourth quarter of 2024
totaled $17.9 million, compared to $20.9 million for the fourth quarter of 2023, and were $80.3 million for the full year 2024 compared
to $65.6 million for the full year 2023. The reduction in fourth quarter 2024 operating expenses compared to the prior year quarter is
primarily attributable to reductions in various compensation plans and reduced professional fees. The increase in operating expenses year
over year was primarily due to additional independent agent sales commissions and higher employee compensation expenses, amortization
of intangible assets associated with the Coflex and CoFix product lines, and increased research and development expenses.
Fourth quarter 2024 net loss totaled $3.2 million,
or $(0.02) per share, compared to a net loss in the fourth quarter 2023 of $4.3 million, or $(0.03) per share. Net loss for 2024 was $16.4
million, or $(0.12) per share, compared to net income of $660,000, inclusive of a $11.7 million bargain purchase gain related to the acquisition
of Surgalign Holdings, or $0.01 per share, for 2023.
Non-GAAP adjusted EBITDA for the fourth quarter of
2024 totaled $438,000, compared to Adjusted EBITDA loss of $695,000 for the same period in 2023. Non-GAAP adjusted EBITDA for 2024 was
a loss of $2.3 million, compared to an adjusted EBITDA loss of $1.4 million for 2023. Beginning in the fourth quarter of 2024, phasing
of the bargain purchase gain on sell through of inventory acquired as part of the purchase of Surgalign Holdings’ hardware and biologics
business is no longer included in acquisition-related fair value adjustments in the non-GAAP adjusted EBITDA calculation and prior period
calculations as presented herein have been recast to conform to the current presentation and calculation. The Company defines adjusted
EBITDA as net income/loss from operations before depreciation, amortization and interest expense and provision for income tax/benefit,
and as further adjusted to add back in or exclude, as applicable, separation related expenses, legal settlements, non-cash compensation,
acquisition-related expense, acquisition-related fair value adjustments, gain on bargain purchase and unrealized foreign currency translation
gain or loss. A calculation and reconciliation of adjusted EBITDA to net loss can be found in the attached financial tables.
As of December 31, 2024, the Company had $6.2 million
of cash and cash equivalents compared to $5.7 million as of December 31, 2023.
2025 Financial Guidance
Xtant Medical initiated revenue guidance for the full
year 2025 of $126 million to $130 million, representing organic growth of 7% to 11%.
Conference Call
Xtant Medical will host a webcast and conference call
to discuss fourth quarter and full year 2024 financial results at 4:30 pm ET on Thursday, March 6, 2025.
To access the webcast, visit https://www.webcaster4.com/Webcast/Page/3039/52116.
To access the conference call, dial 888-506-0062 within
the U.S. or 973-528-0011 outside the U.S. Conference Call Name: Xtant Medical Q4 and Year End 2024 Financial Results.
A replay of the call will be available on the Investor
section of the Company’s website at www.xtantmedical.com.
About Xtant Medical Holdings, Inc.
Xtant Medical’s mission of honoring the gift
of donation so that our patients can live as full and complete a life as possible, is the driving force behind our company. Xtant Medical
Holdings, Inc. (www.xtantmedical.com) is a global medical technology company focused on the design, development, and commercialization
of a comprehensive portfolio of orthobiologics and spinal implant systems to facilitate spinal fusion in complex spine, deformity and
degenerative procedures. Xtant people are dedicated and talented, operating with the highest integrity to serve our customers.
The symbols ™ and ® denote trademarks and
registered trademarks of Xtant Medical Holdings, Inc. or its affiliates, registered as indicated in the United States, and in other countries.
All other trademarks and trade names referred to in this release are the property of their respective owners.
Non-GAAP Financial Measures
To supplement the Company’s consolidated financial
statements prepared in accordance with U.S. generally accepted accounting principles (GAAP), the Company uses certain non-GAAP financial
measures in this release, including adjusted EBITDA. Reconciliations of the non-GAAP financial measures used in this release to the most
comparable GAAP measures for the respective periods can be found in tables later in this release. The Company’s management believes
that the presentation of these measures provides useful information to investors. These measures may assist investors in evaluating the
Company’s operations, period over period. Management uses the non-GAAP measures in this release internally for evaluation of the
performance of the business, including the allocation of resources. Investors should consider non-GAAP financial measures only as a supplement
to, not as a substitute for or as superior to, measures of financial performance prepared in accordance with GAAP.
Cautionary Statement Regarding Forward-Looking
Statements
This press release contains forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements that are predictive
in nature, that depend upon or refer to future events or conditions, or that include words such as “intends,” ‘‘expects,’’
‘‘anticipates,’’ ‘‘plans,’’ ‘‘believes,’’ ‘‘estimates,’’
“continue,” “future,” ‘‘will,’’ “potential,” “going forward,”
“guidance,” similar expressions or the negative thereof, and the use of future dates. Forward-looking statements in this
release include the Company’s full year 2025 revenue guidance and the statement that it expects to begin generating free cash flow
in the second half of 2025, enabling the Company to support expected organic growth without the need for additional external capital.
The Company cautions that its forward-looking statements by their nature involve risks and uncertainties, and actual results may differ
materially depending on a variety of important factors, including, among others: the Company’s future operating results and financial
performance; its ability to increase or maintain revenue; the Company’s ability to become operationally self-sustaining and less
reliant on third-party manufacturers and suppliers; risks associated with its acquisitions and the integration of those businesses; anticipated
shortages of stem cells which will adversely affect future revenues; the ability to implement successfully its future growth initiatives
and risks associated therewith; possible future impairment charges to long-lived assets and goodwill and write-downs of excess inventory;
the ability to remain competitive; the ability to innovate, develop and introduce new products and the success of those products; the
ability to engage and retain new and existing independent distributors and agents and qualified personnel and the Company’s dependence
on key independent agents for a significant portion of its revenue; the effect of labor and hospital staffing shortages on the Company’s
business, operating results and financial condition, especially when they affect key markets; the effect of inflation, increased interest
rates and other recessionary factors and supply chain disruptions; the effect of product sales mix changes on the Company’s financial
results; government and third-party coverage and reimbursement for Company products; the ability to obtain and maintain regulatory approvals
and comply with government regulations; the effect of product liability claims and other litigation to which the Company may be subject;
the effect of product recalls and defects; the ability to license certain of the Company’s intellectual property on commercially
reasonable terms and to maintain any such licenses; the ability to obtain and protect Company intellectual property and proprietary rights
and operate without infringing the rights of others; risks associated with the Company’s clinical trials; international risks;
the ability to service Company debt, comply with its debt covenants and access additional indebtedness; the ability to maintain sufficient
liquidity to fund its operations and obtain financing on favorable terms or at all; and other factors. Additional risk factors are contained
in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 to be filed with the Securities and Exchange
Commission (SEC) on March 6, 2025 and subsequent SEC filings by the Company, including without limitation its most recent Quarterly
Report on Form 10-Q for the quarterly period ended September 30, 2024 filed with the SEC on November 12, 2024. Investors are encouraged
to read the Company’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties.
The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances
after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. All forward-looking statements
attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by this cautionary statement.
Investor Relations Contact:
Brett Maas
Managing Partner, Hayden IR
brett@haydenir.com
(646) 536-7331
XTANT
MEDICAL HOLDINGS, INC.
CALCULATION
OF NON-GAAP CONSOLIDATED EBITDA AND ADJUSTED EBITDA
(In thousands)
| | |
Three Months Ended December 31, | | |
Twelve Months Ended December 31, | |
| | |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| | |
| | |
| | |
| | |
| |
| Net (Loss) Income | |
$ | (3,165 | ) | |
$ | (4,303 | ) | |
$ | (16,449 | ) | |
$ | 660 | |
| | |
| | | |
| | | |
| | | |
| | |
| Depreciation and amortization | |
| 1,148 | | |
| 1,017 | | |
| 4,224 | | |
| 3,174 | |
| Interest expense | |
| 1,134 | | |
| 802 | | |
| 4,160 | | |
| 2,789 | |
| Tax expense (benefit) | |
| 21 | | |
| 577 | | |
| 187 | | |
| (1,697 | ) |
| Non-GAAP EBITDA | |
| (862 | ) | |
| (1,907 | ) | |
| (7,878 | ) | |
| 4,926 | |
| | |
| | | |
| | | |
| | | |
| | |
| Non-GAAP EBITDA/Total revenue | |
| -2.7 | % | |
| -6.8 | % | |
| -6.7 | % | |
| 5.4 | % |
| | |
| | | |
| | | |
| | | |
| | |
| NON-GAAP ADJUSTED EBITDA CALCULATION | |
| | | |
| | | |
| | | |
| | |
| Separation related expenses | |
| 192 | | |
| - | | |
| 682 | | |
| - | |
| Legal settlements | |
| - | | |
| - | | |
| - | | |
| 140 | |
| Non-cash compensation | |
| 840 | | |
| 938 | | |
| 4,117 | | |
| 2,739 | |
| Acquisition-related expense | |
| - | | |
| 929 | | |
| 338 | | |
| 2,255 | |
| Acquisition-related fair value adjustments (1) | |
| 167 | | |
| 276 | | |
| 415 | | |
| 541 | |
| Gain on bargain purchase | |
| - | | |
| (666 | ) | |
| - | | |
| (11,694 | ) |
| Unrealized foreign currency translation (gain) loss | |
| 101 | | |
| (265 | ) | |
| (5 | ) | |
| (265 | ) |
| Non-GAAP Adjusted EBITDA | |
$ | 438 | | |
$ | (695 | ) | |
$ | (2,331 | ) | |
$ | (1,358 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Non-GAAP Adjusted EBITDA/Total revenue | |
| 1.5 | % | |
| -2.5 | % | |
| -2.0 | % | |
| -1.5 | % |
(1)
Beginning in the fourth quarter of 2024, phasing of the bargain purchase gain on sell through of inventory acquired as part of the purchase
of Surgalign Holdings’ hardware and biologics business is no longer included in acquisition-related fair value adjustments in the
non-GAAP adjusted EBITDA calculation and prior period calculations as presented herein have been recast to conform to the current presentation
and calculation. The related effect on adjusted EBITDA was a reduction of $1.4 million for the fourth quarter of 2023, and a reduction
of $2.3 million for the year ended December 31, 2023 to arrive at recast amounts.
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