Xtant Medical Holdings (XTNT) FY2025 10-K Risk Factors: 11 New, 20 Dropped

What the changes say

Asset sales and reimbursement changes will lower 2026 revenue and gross margins.
Internal control weaknesses and high customer concentration create operational risks.

What changed since the prior 10-K

New

NewRisks Related to Our Business
Although we generated net income for the year ended December 31, 2025, we historically have incurred significant losses, expect to continue to incur losses, and despite our focused goal to maintain profitability, we may never achieve sustained profitability
Despite 2025 net income, historical losses may recur and hurt our stock price.
NewRisks Related to Our Business
We recognized a significant amount of license revenue in 2025 that likely will not repeat in 2026 and thus the loss of such revenue will have an adverse impact on our 2026 revenues and other operating results, including gross margins
Loss of $18.7 million in 2025 license revenue due to SimpliMax reimbursement changes will reduce 2026 gross margins.
NewRisks Related to Our Business
Because we recently sold certain assets relating to our Coflex and CoFix products and our international hardware business to Companion Spine, our revenue will be adversely affected in 2026
Sale of Coflex, CoFix, and international hardware assets to Companion Spine removes $20.3 million in 2025 revenue from 2026 results.
NewRisks Related to Our Business
Some of our biologics products, including our OsteoVive Plus, involve a heightened inherent risk of transmission of disease, which if materialized, could adversely affect our business, operating results, financial condition, reputation and stock price
Our OsteoVive Plus viable bone allograft carries an inherent disease transmission risk, including un-testable mycobacterium tuberculosis.
NewRisks Related to Our Business
We face intense competition
We face intense competition from companies with greater financial resources, established surgeon relationships, and broader product lines.
NewRisks Related to Our Business
Our private label and OEM revenue channel involves risks and may be subject to significant fluctuation on a product to product basis from period to period since we typically do not have long-term purchase agreements covering these sales and our customers could decide to use other OEMs
Private label and OEM channels carry lower gross margins and lack long-term agreements, risking revenue fluctuations.
NewRisks Related to Our Business
Also, some transactions may require the consent of the lenders under our credit agreements, and we cannot predict whether such consent would be forthcoming or the terms on which the lenders would approve future transactions
Lender consent may be required for large transactions or acquisitions, risking delay or blockage.
NewRisks Related to Our Business
Our ability to use our net operating loss carry-forwards and other tax attributes to offset future taxable income is limited
Federal net operating loss carryovers of $34.1 million face Section 382 ownership change limitations.
NewRisks Related to Our Business
We identified a material weakness in our internal control over financial reporting as of December 31, 2025, and cannot provide assurances that this weakness will be effectively remediated or that additional material weaknesses will not occur in the future
A material weakness in internal control over financial reporting was identified as of December 31, 2025.
NewRisks Related to Our Common Stock
Nantahala owns a significant percentage of our common stock and is able to exert significant control over matters subject to stockholder approval, preventing other stockholders and new investors from influencing significant corporate decisions
Nantahala Capital Management owns 48.8% of our common stock, allowing them to exert significant control over corporate decisions.
NewRisks Related to Our Common Stock
We are subject to several other general risks that could adversely affect our business, operating results and financial condition
Contagious disease outbreaks could cause medical facilities to cancel or defer elective procedures using our products.

Dropped

DroppedRisks Related to Our Continuing Losses, Outstanding Indebtedness, Need for Additional Financing and Financial Condition
We have incurred significant losses, expect to continue to incur losses, and despite our focused goal to obtain profitability, we may never achieve or sustain profitability
History of net losses and $259.5 million accumulated deficit at December 31, 2024.
DroppedRisks Related to Our Business
Our growth initiatives designed to increase our revenue and scale may not be successful and involve risks
DroppedRisks Related to Our Business
Our dependence on key suppliers of raw materials puts us at risk of interruptions in the availability of our products, which could reduce our sales and adversely affect our operating results and harm our reputation
DroppedRisks Related to Our Business
Our recently entered into license agreements to manufacture and commercially sell in the United States certain of our products and using the trademarks associated therewith and any similar agreements we may enter into may not result in significant revenue
DroppedRisks Related to Our Business
We operate in certain markets outside the United States that are subject to political, economic, and social instability and require management attention and financial resources and expose us to additional risks
Risks related to four key growth initiatives.
DroppedRisks Related to Our Business
We may be required to incur impairment and other charges resulting from the impairment of goodwill or other intangible assets recorded in connection with acquisitions
DroppedRisks Related to Our Business
Fluctuations in foreign currency exchange rates could result in declines in our earnings and changes in our foreign currency translation adjustments
DroppedRisks Related to Our Business
Our ability to deduct interest is limited
Dependence on key suppliers of raw materials.
DroppedRisks Related to Our Business
A shift in performing more procedures in ambulatory surgical centers from hospitals would likely reduce the prices of our products and margins
DroppedRisks Related to Our Business
Our business, operating results and financial condition may be materially adversely affected by the spread of infectious diseases
DroppedRisks Related to Governmental Regulation
Our clinical trials involve risk and expense and may fail to demonstrate competent and reliable evidence of the safety and effectiveness of our products, which in the case of product in development would prevent or delay their commercialization
DroppedRisks Related to Governmental Regulation
Modifications to our products may require new regulatory clearances or approvals, and if we market modified products without obtaining necessary approvals or certifications, we may be required to recall or cease marketing our products until clearances or approvals are obtained
License agreements to manufacture and sell SimpliMax in the US.
DroppedRisks Related to Governmental Regulation
If we or our suppliers fail to comply with regulations pertaining to human cells, tissues, and cellular and tissue-based products or are deemed to be biological products requiring approval of a BLA prior to being marketed, these products could be subject to withdrawal from the market or other enforcement action
DroppedRisks Related to Our Controlled Company Status
We are a “controlled company” within the meaning of the NYSE American rules and rely on exemptions from various corporate governance requirements that provide protection to stockholders of other companies
Operating in international markets across 33 countries.
DroppedRisks Related to Our Common Stock
Our inability to comply with the continued listing requirements of the NYSE American could result in our common stock being delisted, which could affect its market price and liquidity and reduce our ability to raise capital
DroppedRisks Related to Our Common Stock
Our Board of Directors is authorized to issue and designate shares of our preferred stock without stockholder approval
DroppedRisks Related to Our Common Stock
Our Charter designates the Court of Chancery of the State of Delaware as the exclusive forum for certain litigation that may be initiated by our stockholders, which could limit the ability of our stockholders to obtain a favorable judicial forum for disputes with us
DroppedRisks Related to Our Common Stock
Climate change, or legal, regulatory or market measures to address climate change, may materially adversely affect our financial condition and business operations
DroppedRisks Related to Our Common Stock
Changes in accounting standards, policies, or assumptions utilized in determining accounting estimates could adversely affect our financial statements, including our operating results and financial condition
Impairment charges on goodwill or intangible assets from acquisitions.
DroppedRisks Related to Our Common Stock
Scrutiny and evolving expectations from customers, regulators, investors, and other stakeholders with respect to our environmental, social and governance practices may impose additional costs on us or expose us to new or additional risks
Foreign currency exchange rate fluctuations.

Reworded

95% rewrittenRisks Related to Information Technology, Cybersecurity and Data Protection
We are dependent on various information technology (“IT”) systems, and failures of, interruptions to, or unauthorized tampering with those systems could have a material adverse effect on our business
Expanded cybersecurity risks to include third-party networks and removed specific 2024 firewall and security administrator additions.
93% rewrittenRisks Related to Our Common Stock
Our actual operating results may differ significantly from our guidance, which could cause the market price of our common stock to decline
Updated guidance disclosure to note that assumptions are subject to contingencies beyond management control.
93% rewrittenRisks Related to Governmental Regulation
Federal regulatory reforms may adversely affect our business and our ability to sell our products
Updated FDA quality management regulation text to reflect that the QMSR took effect in February 2026.
79% rewrittenRisks Related to Our Business
Persistent inflation, tariffs and supply chain disruptions in the past have resulted in and in the future could result in delayed product launches, lost revenue, higher costs and decreased profit margins
Added a warning that vertical integration efforts to mitigate supply chain weaknesses might fail.
77% rewrittenRisks Related to Governmental Regulation
Any future product recall or voluntary market withdrawal of a product due to defects, enhancements and modifications or other reasons would significantly increase our costs
Minor phrasing polish on product recall causes and governmental authority.
76% rewrittenRisks Related to Governmental Regulation
U.S. governmental regulation could restrict the use of our tissue products or our procurement of tissue
No substantive textual changes detected in the allograft tissue procurement description.
74% rewrittenRisks Related to Our Common Stock
Worldwide economic and market conditions, including with respect to financial institutions, global wars and conflicts, and social unrest could adversely affect our revenue, operating results, liquidity, and/or financial condition
Added global wars and conflicts to macroeconomic risk factors.
Was: Worldwide economic and market conditions, including with respect to financial institutions, and social unrest could adversely affect our revenue, liquidity, financial condition, or results of operations
73% rewrittenRisks Related to Our Outstanding Indebtedness, Need for Additional Financing and Financial Condition
Our Credit Agreements involve additional risks that may adversely affect our liquidity and financial condition
Removed results of operations from the credit agreement liquidity risk impact.
Was: Our Credit Agreements involve additional risks that may adversely affect our liquidity, results of operations, and financial condition
67% rewrittenRisks Related to Our Business
Our biologics business is highly dependent on the availability of human donors and placentas. Any disruptions in the availability of donors and placentas due to regulatory changes or otherwise could cause our customers to seek alternative providers or technologies and harm our business and operating results
Was: Our biologics business is highly dependent on the availability of human donors and placentas. Any disruptions could cause our customers to seek alternative providers or technologies and harm our business and operating results
65% rewrittenRisks Related to Governmental Regulation
Our manufacturing operations are required to comply with the FDA’s and other governmental authorities’ laws and regulations regarding the manufacture and production of medical devices, which is costly and could subject us to enforcement action
63% rewrittenRisks Related to Our Outstanding Indebtedness, Need for Additional Financing and Financial Condition
We may need additional financing to satisfy our future liquidity requirements, which financing may not be available on favorable terms, or at all, at the time it is needed and which could reduce our operational and strategic flexibility
Was: We may need additional financing to satisfy our anticipated future liquidity requirements, which financing may not be available on favorable terms, or at all, at the time it is needed and which could reduce our operational and strategic flexibility
62% rewrittenRisks Related to Our Common Stock
Shares of our common stock are equity securities and are subordinate to our outstanding indebtedness
62% rewrittenRisks Related to Governmental Regulation
Our revenues depend upon prompt and adequate coverage and reimbursement from public and private insurers and national health systems
58% rewrittenRisks Related to Our Common Stock
We may issue additional common stock resulting in stock ownership dilution
57% rewrittenRisks Related to Our Business
Our prior acquisitions and dispositions and any future acquisitions, dispositions or business combinations we complete involve a number of risks, the occurrence of which could adversely affect our business, operating results and financial condition
Was: Our prior acquisitions and any future acquisitions or business combinations we complete involve a number of risks, the occurrence of which could adversely affect our business, reputation, operating results and financial condition
56% rewrittenRisks Related to Our Business
Biologics products are inherently difficult and time-consuming to manufacture. In the past, we have experienced and in the future could experience manufacturing issues, which could negatively impact our business and operating results
Was: Biologics products are inherently difficult and time-consuming to manufacture. We have experienced and could continue to experience manufacturing issues, which could negatively impact our business and results of operations
55% rewrittenRisks Related to Our Common Stock
The sale or availability for sale of substantial amounts of our common stock, or the perception that such sales could occur at any time, could adversely affect the market price of our common stock
Was: The sale or availability for sale of substantial amounts of our common stock or other equity securities could adversely affect the market price of our common stock
50% rewrittenRisks Related to Our Business
Our quarterly operating results are subject to substantial fluctuations, and you should not rely on them as an indication of our annual or future results
43% rewrittenRisks Related to Governmental Regulation
We are subject, directly and indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, and physician payment transparency laws. Failure to comply with these laws may subject us to substantial penalties
30% rewrittenRisks Related to Our Business
If we are unable to innovate, develop, introduce, market, sell and license new products and technologies, we may experience a decrease in market share or revenue if our products become obsolete, and our business and operating results would suffer
25% rewrittenRisks Related to Human Capital Management
We have limited staffing and are dependent upon key employees
24% rewrittenRisks Related to Our Common Stock
Anti-takeover provisions in our organizational documents and agreements may discourage or prevent a change in control, even if a sale of the Company could be beneficial to our stockholders, which could cause our stock price to decline and prevent attempts by our stockholders to replace or remove our current management

All 47 risk factors

Headings as the filing states them, in filing order.

Risks Related to Our Business

01Although we generated net income for the year ended December 31, 2025, we historically have incurred significant losses, expect to continue to incur losses, and despite our focused goal to maintain profitability, we may never achieve sustained profitabilityNew
02We recognized a significant amount of license revenue in 2025 that likely will not repeat in 2026 and thus the loss of such revenue will have an adverse impact on our 2026 revenues and other operating results, including gross marginsNew
03Because we recently sold certain assets relating to our Coflex and CoFix products and our international hardware business to Companion Spine, our revenue will be adversely affected in 2026New
04A substantial portion of our hardware product family revenue is conducted through independent sales agents and distributors who we do not control and our revenue from this channel has declined in recent periods compared to prior periods
05If we are unable to innovate, develop, introduce, market, sell and license new products and technologies, we may experience a decrease in market share or revenue if our products become obsolete, and our business and operating results would suffer30% rewritten
06Biologics products are inherently difficult and time-consuming to manufacture. In the past, we have experienced and in the future could experience manufacturing issues, which could negatively impact our business and operating results56% rewritten
07Our biologics business is highly dependent on the availability of human donors and placentas. Any disruptions in the availability of donors and placentas due to regulatory changes or otherwise could cause our customers to seek alternative providers or technologies and harm our business and operating results67% rewritten
08Some of our biologics products, including our OsteoVive Plus, involve a heightened inherent risk of transmission of disease, which if materialized, could adversely affect our business, operating results, financial condition, reputation and stock priceNew
09Persistent inflation, tariffs and supply chain disruptions in the past have resulted in and in the future could result in delayed product launches, lost revenue, higher costs and decreased profit margins79% rewritten
10We face intense competitionNew
11Our private label and OEM revenue channel involves risks and may be subject to significant fluctuation on a product to product basis from period to period since we typically do not have long-term purchase agreements covering these sales and our customers could decide to use other OEMsNew
12Our prior acquisitions and dispositions and any future acquisitions, dispositions or business combinations we complete involve a number of risks, the occurrence of which could adversely affect our business, operating results and financial condition57% rewritten
13Also, some transactions may require the consent of the lenders under our credit agreements, and we cannot predict whether such consent would be forthcoming or the terms on which the lenders would approve future transactionsNew
14Negative publicity concerning methods of tissue recovery and screening of donor tissue in our industry could reduce demand for our biologics products and impact the supply of available donor tissue
15We are highly dependent on the continued availability of our facilities and would be harmed if they were unavailable for any prolonged period of time
16We may be party to product liability litigation that could be expensive, and our insurance coverage may not be adequate in a catastrophic situation
17Our quarterly operating results are subject to substantial fluctuations, and you should not rely on them as an indication of our annual or future results50% rewritten
18Our ability to use our net operating loss carry-forwards and other tax attributes to offset future taxable income is limitedNew
19We identified a material weakness in our internal control over financial reporting as of December 31, 2025, and cannot provide assurances that this weakness will be effectively remediated or that additional material weaknesses will not occur in the futureNew

Risks Related to Governmental Regulation

20Loss of AATB accreditation would have a material adverse effect on us
21U.S. governmental regulation could restrict the use of our tissue products or our procurement of tissue76% rewritten
22Our manufacturing operations are required to comply with the FDA’s and other governmental authorities’ laws and regulations regarding the manufacture and production of medical devices, which is costly and could subject us to enforcement action65% rewritten
23If our products cause or contribute to a death or serious injury, or malfunction in certain ways, we will be subject to reporting regulations, which can result in voluntary corrective actions or agency or other governmental enforcement actions
24Any future product recall or voluntary market withdrawal of a product due to defects, enhancements and modifications or other reasons would significantly increase our costs77% rewritten
25We are subject, directly and indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, and physician payment transparency laws. Failure to comply with these laws may subject us to substantial penalties43% rewritten
26The use, misuse or off-label use of our products may harm our image in the marketplace or result in injuries that lead to product liability suits, which could be costly to our business or result in FDA sanctions if we are deemed to have engaged in improper promotion of our products
27Federal regulatory reforms may adversely affect our business and our ability to sell our products93% rewritten
28Our revenues depend upon prompt and adequate coverage and reimbursement from public and private insurers and national health systems62% rewritten

Risks Related to Human Capital Management

29We have limited staffing and are dependent upon key employees25% rewritten

Risks Related to Intellectual Property

30If we lose any future intellectual property lawsuits, a court could require us to pay significant damages or prevent us from selling our products
31If our patents and other intellectual property rights do not adequately protect our products, we may lose market share to our competitors and be unable to operate our business profitably
32We may not be able to obtain or protect our proprietary rights relating to our products without resorting to costly and time-consuming litigation

Risks Related to Information Technology, Cybersecurity and Data Protection

33We are dependent on various information technology (“IT”) systems, and failures of, interruptions to, or unauthorized tampering with those systems could have a material adverse effect on our business95% rewritten

Risks Related to Our Outstanding Indebtedness, Need for Additional Financing and Financial Condition

34Any of these factors could materially and adversely affect our business, financial condition, and operating results. In addition, we may incur additional indebtedness, and if we do, the risks related to our business and our ability to service our indebtedness would increase
35Our Credit Agreements involve additional risks that may adversely affect our liquidity and financial condition73% rewritten
36We may need additional financing to satisfy our future liquidity requirements, which financing may not be available on favorable terms, or at all, at the time it is needed and which could reduce our operational and strategic flexibility63% rewritten

Risks Related to Our Common Stock

37Nantahala owns a significant percentage of our common stock and is able to exert significant control over matters subject to stockholder approval, preventing other stockholders and new investors from influencing significant corporate decisionsNew
38Shares of our common stock are equity securities and are subordinate to our outstanding indebtedness62% rewritten
39The market price of our common stock is extremely volatile, which may affect our ability to raise capital in the future and may subject the value of the investment of our stockholders to sudden decreases
40Our actual operating results may differ significantly from our guidance, which could cause the market price of our common stock to decline93% rewritten
41We may issue additional common stock resulting in stock ownership dilution58% rewritten
42The sale or availability for sale of substantial amounts of our common stock, or the perception that such sales could occur at any time, could adversely affect the market price of our common stock55% rewritten
43If securities analysts stop publishing research or reports about us or our business, or if they downgrade our common stock, the trading volume and market price of our common stock could decline
44Anti-takeover provisions in our organizational documents and agreements may discourage or prevent a change in control, even if a sale of the Company could be beneficial to our stockholders, which could cause our stock price to decline and prevent attempts by our stockholders to replace or remove our current management24% rewritten
45We have never paid dividends and do not expect to do so in the foreseeable future
46Worldwide economic and market conditions, including with respect to financial institutions, global wars and conflicts, and social unrest could adversely affect our revenue, operating results, liquidity, and/or financial condition74% rewritten
47We are subject to several other general risks that could adversely affect our business, operating results and financial conditionNew

Other Xtant Medical Holdings 10-Ks

FY2024 10-K risk factors
56 risks
Xtant Medical operates with a history of net losses and a deficit of $259.5 million as of December 31, 2024. The company depends heavily on independent sales agents, tissue donors, and its Belgrade, Montana manufacturing facility. Growth relies on four key initiatives, strategic acquisitions, and compliance with complex FDA medical device and biologics regulations.
Filed Mar 06, 2025

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.