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MDXG 10-K & 10-Q changes, risk factors and insider trading

Mimedx Group, Inc. · Nasdaq · Surgical & Medical Instruments & Apparatus · CIK 1376339 · All filings on SEC.gov

Everything below is quoted or computed from Mimedx Group, Inc.'s public SEC filings. It is not a recommendation to buy or sell. Automated comparisons can contain errors; confirm with the original filing.

At a glance

17 / 5risk-factor paragraphs added / removed in latest 10-K
2new risk-factor headings
0Form 4 filings reporting open-market purchases (last 180 days)
0Form 4 filings reporting open-market sales (last 180 days)

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What changed in the latest 10-K

Comparing 10-K filed 2026-02-25 (period ending 2025-12-31) with 10-K filed 2025-02-26 (period ending 2024-12-31).

Risk Factors (10-K Item 1A)

17new paragraphs
5removed paragraphs
24reworded paragraphs
13,882 → 14,545words in section

New heading “Increased use of artificial intelligence (“AI”) and related technologies in the medical device industry could subject us to new risks and uncertainties, and our failure to effectively evaluate or adopt such technologies could adversely affect our business.”

New heading “Our capital allocation decisions, including decisions regarding share repurchases, investments in inorganic opportunities, and other capital allocation activities, may not achieve their intended benefits and could adversely affect our financial condition and stock price.”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

New text topics: artificial intelligence
“Increased use of artificial intelligence (“AI”) and related technologies in the medical device industry could subject us to new risks and uncertainties, and our failure to effectively evaluate or adopt such technologies could adversely affect our business.”
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New text
“Our capital allocation decisions, including decisions regarding share repurchases, investments in inorganic opportunities, and other capital allocation activities, may not achieve their intended benefits and could adversely affect our financial condition and stock price.”
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New text topics: ai, regulation
“The adoption of AI technologies could subject us to evolving and uncertain regulatory requirements. Regulatory authorities, including the FDA and international counterparts, are actively assessing the appropriate oversight of AI-enabled tools and products. New or revised regulations, guidance, or enforcement practices could impose additional compliance obligations, increase development and validation costs, limit permissible uses of AI, or delay the deployment of AI-enabled solutions.”
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New text topics: artificial intelligence, ai
“Artificial intelligence, machine learning, and other automated technologies are being increasingly explored and adopted across the medical device industry, including in product development, manufacturing, quality systems, regulatory processes, clinical support, and commercial activities. We may evaluate or elect to adopt AI technologies in the future as part of our efforts to remain competitive and operate efficiently.”
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New text topics: liquidity
“We regularly evaluate opportunities to deploy capital, including investing in our business, pursuing strategic acquisitions, reducing indebtedness, returning capital to shareholders through dividends or share repurchases, or retaining capital for future flexibility. Our capital allocation decisions are subject to significant judgment and are influenced by a number of factors, including market conditions, our financial performance and liquidity, tax considerations, regulatory requirements, and the availability of alternative or inorganic investment opportunities.”
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Removed text topics: pandemic
“Notably, the COVID-19 pandemic had a significant impact on the nation’s health sector expenditures, beginning in 2020, primarily driven by increased federal spending, including financial assistance to providers to make up for lost revenue through the Provider Relief Fund, the Paycheck Protection Program, and increased federal public health spending such as spending for vaccine development, COVID testing, and health facility preparedness. As a result, growth in federal government spending on healthcare increased 36% in 2020.”
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Green = added, red = removed. Unchanged paragraphs, 2 paragraphs where only numbers/dates changed, and tables are not shown. Read the complete text in the original filing.

Reworded

An investment in our Common Stock involves a substantial risk of loss. Set forth below is a summary of the risks and uncertainties affecting our business that we currently believe to be material. Our future operating results could differ materially from the results described in this Annual Report due to the risks and uncertainties described below. We caution you to read the following risk factors, which have affected, and/or in the future could affect, our business, prospects, operating results, and financial condition. Additional risks and uncertainties not currently known to us or that we currently deem immaterial may also affect our business, prospects, operating results, and financial condition. Additional risks and uncertainties are described under other captions in this report and should also be considered by our stockholders. If any of these risks materialize, our business, financial condition or operating results could suffer. In this case, the trading price of our Common Stock could decline, and you may lose part or all of your investment.

Reworded

Our business is in a very competitive and evolving field. Competition from other tissue processors, medical device companies, and biotherapeutic companies, and from research and academic institutions, is intense, expected to increase and subject to rapid change and could be significantly affected by new product introductions as well as changes in reimbursement that could favor certain products and competitors over others. Established competitors and newer market entrants are investing in additional clinical research that may allow them to gain further clinician usage, adoption and payer coverage of their products. In addition, consolidation and cost containment measures in the healthcare industry may cause hospitals to consolidate their purchases with suppliers that have a broad portfolio of products. This would continue to give rise to demands for price concessions, which could have an adverse effect on our business, results of operations and financial condition. Further, competitors may introduce placental-based membrane products in the future at lower prices, adding new features or gaining additional reimbursement coverage, or utilize sales and marketing practices that negatively impact the industry. Further, they may copy our products inside or outside the United States. The presence of this competition may lead to pricing pressure, which could have an adverse effect on our business, results of operations and financial condition.

Reworded

The commercial success of our human tissue products depends upon, among other factors, the availability of tissue from human donors. Any failure to obtain tissue from our sources will interfere with our ability to effectively meet demand for our products incorporating human tissue. The availability of donated tissue could also be adversely impacted by regulatory changes, public opinion of the donor process and our own reputation in the industry. We may not be successful in our ability to scale tissue recovery efforts to meet the potential future demand of our pipeline. Obtaining adequate supplies of human tissue involves several risks, including limited control over availability (due toto, for example, access to hospital accounts and the number of consenting mothers), quality, delivery schedules, and eligibility requirements. In addition, any interruption in the supply of any human tissue component could harm our ability to manufacture our products until a new source of supply, if any, could be found. We also utilize third-party providers of placental donations on an as-needed basis to mitigate risks but there can be no assurance that these third parties will be able to provide donated tissues at all times. We may be unable to find a sufficient alternative supply channel in a reasonable time period or on commercially reasonable terms, if at all, which would have an adverse effect on our business, results of operations and financial condition.

Removed

Our success depends on the extent to which our customers receive adequate reimbursement for the costs of our products and related treatments from third-party payers, including government healthcare programs, such as Medicare and Medicaid, as well as private insurers and health systems. Government and other third-party payers attempt to contain healthcare costs by limiting both coverage and the level of reimbursement of medical products, particularly new products. Therefore, significant uncertainty may exist as to the reimbursement status of new healthcare products by third-party payers. Although EPIFIX and EPICORD have coverage with the majority of large payers, a significant number of public and private insurers currently do not cover or reimburse our other products.

Reworded

The reimbursement landscape for our products varies depending upon the site in which the products are administered. If we are not successful in obtaining adequate coverage and reimbursement for our products from these third-party payers in one or more of the sites of service where our products are used, it could have an adverse effect on market acceptance of our products. Inadequate reimbursement levels would likely also create downward price pressure on our products. Even if we do succeed in obtaining widespread coverage and reimbursement rates or policies for our products, future changes in coverage or reimbursement rates or policies could have a negative impact on our business, financial condition and results of operations.

Added

Inadequate reimbursement levels would likely also create downward price pressure on our products. Even if we do succeed in obtaining widespread coverage and reimbursement rates or policies for our products, future changes in coverage or reimbursement rates or policies could have a negative impact on our business, financial condition and results of operations.

Added

At the end of 2025, CMS announced sweeping changes related to the reimbursement of skin substitutes, beginning January 1, 2026. These changes include: 1) reimbursing skin substitute products uniformly across the HOPD and physician office and associated care settings and 2) changing the reimbursement rate for skin substitutes from the “ASP+6%” methodology to a flat rate at $127.14 per square centimeter in these care settings, subject to geographic adjustments. The specific policies were put into effect in the PFS and OPPS.

Added

Historically, third-party payors often rely on the coverage policies and payment limitations imposed by Medicare and other government payors, in setting their own coverage policies and reimbursement rates. Our inability to promptly obtain coverage and profitable payment rates from hospital budget, government-funded and private payors, could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize products and our overall financial condition. Healthcare reform measures such as the 2026 reimbursement changes may result in additional reductions in Medicare and other healthcare funding, more rigorous coverage criteria, new payment methodologies and additional downward pressure on the price that we receive for any approved product. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product offerings.

Added

In the past, we have also experienced some reluctance by payers to cover our products under certain circumstances, including for applications other than those for which we have published clinical efficacy data. We continue to publish additional scientific, clinical and health outcomes literature in support of the use of products more broadly, but there can be no assurance that these publications and associated efforts will influence coverage determinations or reimbursement amounts. Given the unknowns of the new reimbursement landscape, we may need to tighten inventory management to minimize losses from unused products and also revisit pricing strategies in light of the new reimbursement model.

Removed

Further, we have experienced some reluctance by payers to cover our products under certain circumstances, including for applications other than those for which we have published clinical efficacy data. Since 2022, several wide-ranging proposals have been published for public comment, including relating to payment methodology within the physician office, with potential to change how CMS reimburses for skin substitute products at a national level.

Reworded

Changes in the coverage and reimbursement environment as described above and the impact it could have on clinical practice and physician behavior, which will only become clear as implementation progresses, could result in declines in our revenue that would adversely affect our business, financial condition and results of operation.

Reworded

Our agreements with GPOs and IDNs allow us to sell our products efficiently to large groups of customers. Our agreements with GPOs and IDNs typically provide their members with favorable ordering terms and conditions and access to favorable product pricing. These customers purchase our product through GPO and IDN arrangements in part because of the favorable pricing and terms and conditions. IfIf, as a result of competition, pricing, or any other reason, our agreement with any GPO or IDN is terminated or expires without being extended, renewed or renegotiated, this could adversely affect our revenue, results of operations and cash flows.

Added

We do not own our processing facilities and our business could be harmed if we are not able to renew our leases or relocate on favorable terms. Our ability to negotiate a favorable extension or a new lease for an alternative facility depends on factors beyond our control, including landlord disputes or increases in local real estate market rates. If we were unable to renew our leases or relocate on favorable terms, this could have a material adverse effect on our business, financial condition and results of operations.

Reworded

•their lack of experience with advanced therapeutics, such as our placenta-based allograftsallografts, xenografts or xenograftsother advanced therapies;

Reworded

•lack of evidence supporting additional patient benefits of advanced therapeutics, such as our placenta-based allograftsallografts, xenografts or xenografts,other advanced therapies, over conventional methods in certain therapeutic applications;

Added

If we are unsuccessful in educating physicians to maintain or increase adoption of our products, it could have an adverse effect on our business and results of operations.

Reworded

To ensure protection of our information, we have invested in cybersecurity and have implemented processes and procedural controls to maintain the confidentiality and integrity of such information. We measure these controls and their success through a cybersecurity framework that is based on industry standards. Refer to Item 1C, Cybersecurity, for additional discussion. While we have invested in the protection of our data and technology, there can be no guarantees that our efforts will prevent all service interruptions or security breaches. Any such interruption or breach of our systems could adversely affect our business operations and result in the loss of critical or sensitive confidential information or intellectual property, and could result in financial, legal and reputational harm to our business, including legal claims and proceedings, liability under laws that protect the privacy of personal information, government enforcement actions and regulatory penalties, as well as remediation costs. We also maintain cyber liability insurance. However, this insurance may not be sufficient to cover the financial, legal or reputational losses that may result from an interruption or breach of our systems.

Added

Increased use of artificial intelligence (“AI”) and related technologies in the medical device industry could subject us to new risks and uncertainties, and our failure to effectively evaluate or adopt such technologies could adversely affect our business.

Added

Artificial intelligence, machine learning, and other automated technologies are being increasingly explored and adopted across the medical device industry, including in product development, manufacturing, quality systems, regulatory processes, clinical support, and commercial activities. We may evaluate or elect to adopt AI technologies in the future as part of our efforts to remain competitive and operate efficiently.

Added

The adoption of AI technologies could subject us to evolving and uncertain regulatory requirements. Regulatory authorities, including the FDA and international counterparts, are actively assessing the appropriate oversight of AI-enabled tools and products. New or revised regulations, guidance, or enforcement practices could impose additional compliance obligations, increase development and validation costs, limit permissible uses of AI, or delay the deployment of AI-enabled solutions.

Added

The use of AI also presents operational, legal, and reputational risks. AI systems may produce inaccurate, incomplete, or biased outputs, and reliance on such outputs could negatively affect business decisions, product development, manufacturing processes, or regulatory and quality activities. In addition, the use of AI may increase our exposure to cybersecurity, data privacy, and intellectual property risks, particularly where third-party tools, datasets, or platforms are involved.

Added

Moreover, if competitors more effectively or more rapidly adopt AI technologies, they may achieve operational efficiencies, cost advantages, improved product offerings, or enhanced customer engagement that we are unable to match. Conversely, if we adopt AI without appropriate governance, controls, or expertise, we could incur increased costs, operational disruptions, or reputational harm.

Added

Our ability to successfully assess whether, when, and how to adopt AI technologies, and to manage the associated risks, will depend on a number of factors that are difficult to predict. Any failure to appropriately respond to the increasing role of AI in our industry could adversely affect our business, results of operations, or competitive position.

Reworded

Some of our revenues are derived from sales, both direct and through a distributor,sales to the government. Any disruption of our products on the FSS or any change in the way the government purchases products like ours or the price it is willing to pay for our products could adversely affect our business, results of operations and financial condition.

Reworded

ManyCurrently, all of the products we manufacture and process are derived from human tissue. Amniotic and other birth tissue have in the past generally been regulated as HCT/P and were therefore eligible to be subject to regulation solely under Section 361 (“Section 361 HCT/P”) depending on whether the specific product at issue and the claims made for it were consistent with the applicable criteria. HCT/Ps that do not meet these criteria are subject to more extensive regulation as drugs, medical devices, biological products, or combination products. These HCT/Ps must comply with both the FDA’s requirements for HCT/Ps and the requirements applicable to biologics, devices or drugs, including pre-market clearance or approval from the FDA. Obtaining FDA pre-market clearance or approval involves significant time and investment by the Company.

Reworded

The process of obtaining formal FDA clearance or approval, such as a 510(k), BLA,Biological License Application (“BLA”), or equivalent, including clinical trial development and execution as well as manufacturing processes, requires the expenditure of substantial time, effort and financial resources and may take years to complete, including costs incurred on top of those fees incurred as part of conducting various clinical studies. The fee for filing such submissions and program fees payable with respect to any establishment that manufactures biologics are substantial. The FDA may not grant approval on a timely basis, or at all, or we may decide not to pursue this pathway for certain products or indications, or need to conduct additional trials for a given indication. Additionally, the FDA may limit the indications for use or place other conditions on any approvals that could restrict the commercial application of the products. If we do receive approval, some types of changes to the approved product, such as adding new indications or doses, manufacturing changes and additional labeling claims, are subject to further testing requirements and FDA review and approval. Our revenues could be adversely affected if we fail to obtain approvals and clearances on a timely basis or at all, or if the FDA limited the indications for use or required other conditions that restrict the commercial application of our products.

Reworded

Finally, we and other manufacturers of skin substitutes are required to provide average sales price (“ASP”) information to CMS on a quarterly basis. The Medicare payment rates are updated quarterly based on this ASP information. If a manufacturer is found to have made a misrepresentation in the reporting of ASP, such manufacturer is subject to civil monetary penalties of up to $10,000 for each misrepresentation for each day in which the misrepresentation was applied, and potential False Claims Act liability. See “We and our sales representatives, whether employees or independent contractors, must comply with various federal and state anti-kickback, self-referral, false claims and similar laws, any breach of which could cause an adverse effect on our business, results of operations and financial condition.”

Reworded

As a general rule, FDA regulations require that the marketing of Section 361 HCT/Ps only be for appropriate homologous uses, and that the promotion of pre-approved biological products or devices only be for FDA-approved indications. Generally, unless the products are approved by the FDA for alternative uses, the FDA contends that we may not make claims about the safety or effectiveness of our products, or promote them as safe or effective for uses other than those specifically approved by the FDA. Such limitations present a risk that the FDA or other federal or state law enforcement authorities could determine that the nature and scope of our sales, marketing and support activities, though designed to comply with all FDA requirements, constitute the promotion of our products for an unapproved use in violation of the Federal Food Drug & Cosmetic Act. We also face the risk that the FDA or other governmental authorities might pursue enforcement based on past activities that we have discontinued or changed, including sales activities, prior marketing materials, arrangements with institutions and doctors, educational and training programs and other activities.

Reworded

Nevertheless, while we believe we are fully in compliance with the FDA's Guidance on HCT/Ps, there can be no assurance that we have correctly interpreted the FDAFDA’s Guidance, or that we will not need to discontinue marketing a product and/or may be subject to fines, penalties, injunctions, and other sanctions if we are deemed to be promoting the use of our products for unapproved uses. Such regulatory penalties by the FDA could adversely affect our business and results of operations.

Reworded

The FCA imposes civil liability on any person or entity that knowingly submits, or causes the submission of, a false or fraudulent claim to the U.S. government. Damages under the FCA can be significant and consist of the imposition of fines and penalties. The FCA also allows a private individual or entity to sue on behalf of the government to recover civil penalties and treble damages as a whistleblower. FCA liability is potentially significant in the healthcare industry because the statute provides for treble damages and mandatory penalties of between $13,946$14,308 and $27,894$28,619 per false claim or statement for penalties assessed after FebruaryJuly 12,3, 2024,2025, with respect to violations occurring after November 2, 2015.

Removed

Notably, the COVID-19 pandemic had a significant impact on the nation’s health sector expenditures, beginning in 2020, primarily driven by increased federal spending, including financial assistance to providers to make up for lost revenue through the Provider Relief Fund, the Paycheck Protection Program, and increased federal public health spending such as spending for vaccine development, COVID testing, and health facility preparedness. As a result, growth in federal government spending on healthcare increased 36% in 2020.

Reworded

Within our industry, Medicare expenditures on skin substitute products have increased dramatically from 2019, when annual spending on these products administered in private physician offices and associated care settings was approximately $0.5 billion. By 2023,2024, annual expenditures for this class of products totaled overapproximately $4$10 billion, and more recently, spending by Medicare hasapproached reacheda an excess of $1$15 billion perannual monthrun in the category.rate. As a result, CMS”) and the MACs have sought ways to implement coverage and payment reform in order to curb the dramatically increasing expenditures in our industry.

Added

At the end of 2025, CMS announced sweeping changes related to the reimbursement of skin substitutes, beginning January 1, 2026. These changes include: 1) reimbursing skin substitute products uniformly across the HOPD and physician office and associated care settings and 2) changing the reimbursement rate for skin substitutes from the “ASP+6%” methodology to a flat rate at $127.14 per square centimeter in these care settings, subject to geographic adjustments. The specific policies were put into effect in the PFS and OPPS.

Removed

CMS could alter the reimbursement dynamics in outpatient care settings through the Physician Fee Schedule (“PFS”), which is published on an annual basis and regulates payments to healthcare providers for services furnished in these settings. In 2022, CMS, through its publication of the PFS proposals for CY 2023, indicated that it was considering a revision of the payment system for skin substitutes. Specifically, CMS proposed to change the terminology of skin substitutes to ‘wound care management products’, and to treat and pay for these products as incident to supplies under the PFS beginning on January 1, 2024. Ultimately, CMS decided to provide interested parties with more opportunities to comment on the specific details of changes in coding and payment mechanisms prior to finalizing any changes. To date, CMS has not altered the existing policies.

Removed

In August 2023, three MACs issued updated LCDs entitled: “Skin Substitute Grafts/Cellular and/or Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers,” which would regulate our products’ Medicare coverage in the private physician office and associated care settings. Following a comment period and lengthy discussions with industry and clinician stakeholders, these LCDs were ultimately withdrawn ahead of their scheduled effective date. In November 2024, all seven MACs proposed revised LCDs in unison with support from CMS, which took into consideration many of the findings and commentary from the withdrawn 2023 LCDs. These LCDs are scheduled to become effective on April 13, 2025. In the past, LCDs have been delayed or terminated. If these LCDs were to be delayed or terminated, they may not go into effect in April 2025.

Reworded

Changes to the manner and amounts Medicare reimburses for our products could have an impact on their utilization. We believe that substantial uncertainty remainsand unknowns remain regarding the specific reform measures and proposed legislation that could impact our industry. Any changes will likely take time to unfold and could have an impact on coverage and reimbursement for healthcare items and services, including our products.

Reworded

We currently market our products in a smalllimited number of foreign countries, including in Japan. Foreign jurisdictions require separate regulatory approvals and compliance with numerous and varying regulatory requirements. The approval procedures vary among countries and may involve requirements for additional testing. Certain of our products require clearance or approval by the FDA. However, such clearance or approval does not ensure approval or certification by regulatory authorities in other countries or jurisdictions, and approval or certification by one foreign regulatory authority does not ensure approval or certification by regulatory authorities in other foreign countries or by the FDA. The foreign regulatory approval or certification process may include all of the risks associated with obtaining FDA clearance or approval. We may not obtain foreign regulatory approvals on a timely basis, if at all. We may not be able to file for regulatory approvals or certifications and may not receive necessary approvals to commercialize our products in any foreign jurisdiction. Furthermore, many foreign jurisdictions operate under socialized medical care, and obtaining reimbursement for our products under that construct may also prove difficult. If we fail to receive necessary approvals, certifications, or reimbursements necessary to commercialize our products in foreign jurisdictions on a timely basis, or at all, our business, results of operations and financial condition could be adversely affected. Further, governmental authorities outside the U.S. have become increasingly stringent in their regulation of medical devices, and our products may become subject to more rigorous regulation by non-U.S. governmental authorities in the future. U.S. or non-U.S. government regulations may be imposed in the future that may have a material adverse effect on our business and operations.

Reworded

Our success depends significantly on our ability to protect our proprietary rights to the technologies used in our products. We rely on patent protection, as well as a combination of copyright, trade secret and trademark laws and nondisclosure, confidentiality and other contractual restrictions to protect our proprietary technology, including our licensed technology. These legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep any competitive advantage. In addition, our pending patent applications include claims to material aspects of our products and procedures that may not be protected by issued patents. The patent application process can be time consuming and expensive. Our pending patent applications might not result in issued patents, and issued patents may later be determined to be invalid or unenforceable as a result of district court litigation or related administrative proceedings. Competitors may be able to design around our patents or develop products that provide outcomes that are comparable or even superior to ours. Although we have taken steps to protect our intellectual property and proprietary technology, including entering into confidentiality agreements and intellectual property assignment agreements with some of our officers, employees, consultants and advisors, such agreements may not be enforceable or may not provide meaningful protection for our trade secrets or other proprietary information in the event of unauthorized use or disclosure or other breaches of the agreements.

Reworded

As of December 2024,2025, the Companywe had aggregate borrowings outstanding of $19.0$18.0 million under itsour Term Loan Facility, pursuant to itsour Citizens Credit Agreement (as defined below in Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations). Our outstanding debt may limit our ability to borrow additional funds or may adversely affect the terms on which such additional funds may be available. Additionally, a default under certain other indebtedness constitutes an event of default under the Citizens Credit Agreement. Consequently, the effects of a default under other debt may be amplified by the lenders exercising the remedies available to it in the Citizens Credit Agreement for events of default, including foreclosure on the collateral securing our obligations and the declaration that all amounts outstanding under the Citizens Credit Agreement are immediately due and payable.

Reworded

The Citizens Credit Agreement also contains certain customary events of default, including, without limitation, (i) failure to pay interest or principal when due, (iii) failure to provide notice of certain material events and (iii) failure to perform or observe certain covenants under the Citizens Credit Agreement or any related loan documents (subject to a 30-day grace period in certain circumstances). If an event of default occurs and is continuing, the agent under the agreement may, and at the direction of the lenders, take one or more of the following actions: (i) terminate the commitments, (ii) declare any amounts outstanding immediately due and payable, and (iii) exercise any other right it has under the Citizens Credit Agreement or at law. Compliance with such covenants may restrict our operating flexibility, and in the event that we were unable to comply with such covenants, leading to default and acceleration, this could adversely affect our business, results of operations and financial condition.

Reworded

As of December 31, 2024,2025, EW Healthcare Partners and their affiliates beneficially owned approximately 19.3%19% of our Common Stock (calculated on the basis described in Item 12, “Security Ownership Of Certain Beneficial Owners And Management” below).Stock. Also, for as long as EW Healthcare Partners and its affiliates collectively hold at least (i) 10% of the outstanding shares of our Common Stock, EW Healthcare Partners has the right to select two individuals that the Company must include among its nominees to serve on our Board and (ii) 5% (but less than 10%) of the outstanding shares of our outstanding Common Stock, EW Healthcare Partners has the right to select one individual that the Company must include among its nominees to serve on our Board. EW Healthcare Partners designated Martin P. Sutter and William A. Hawkins, III, who continue to serve on our board as directors. The interests of EW Healthcare Partners may conflict with those of our other shareholders, and EW Healthcare Partners may seek to influence, and may be able to influence, us through its director nomination rights and its share ownership.

Reworded

We have never declared or paid cash dividends on our Common Stock. We currently expect to usedeploy availableour fundscapital andtoward anyvarious futuregoals, earnings; inincluding the development, operation and expansion of our business;business, tothe repayrepayment debt;of debt, and, to the extent authorized by our Board, repurchasingpotential repurchases of our Common Stock. We do not anticipate paying any cash dividends on our Common Stock in the foreseeable future. As a result, capital appreciation, if any, of our Common Stock will be an investor’s only source of potential gain from our Common Stock for the foreseeable future.

Added

Our capital allocation decisions, including decisions regarding share repurchases, investments in inorganic opportunities, and other capital allocation activities, may not achieve their intended benefits and could adversely affect our financial condition and stock price.

Added

We regularly evaluate opportunities to deploy capital, including investing in our business, pursuing strategic acquisitions, reducing indebtedness, returning capital to shareholders through dividends or share repurchases, or retaining capital for future flexibility. Our capital allocation decisions are subject to significant judgment and are influenced by a number of factors, including market conditions, our financial performance and liquidity, tax considerations, regulatory requirements, and the availability of alternative or inorganic investment opportunities.

Added

In February 2026, our Board authorized us to periodically repurchase up to $100.0 million of our common shares (the “Share Repurchase Plan” through February 2028. The Share Repurchase Plan does not obligate the Company to repurchase any number of shares and may be suspended or discontinued at any time.

Added

Share repurchases are one method with which we may return capital to stockholders. However, there can be no assurance that any repurchases will enhance long-term shareholder value. Repurchases, if any, may be executed at prices that are higher than the market price of our common stock at a later date, or at times when other uses of capital would have produced greater returns. In addition, repurchases reduce the amount of cash available for other purposes, including investments in organic growth, acquisitions, debt repayment, or other strategic initiatives, which could limit our ability to respond to changing business conditions. In addition, share repurchases may be subject to excise taxes, which could further restrict our ability to deploy capital toward other purposes.

Management's Discussion & Analysis (MD&A) (10-K Item 7)

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5,126 → 4,962words in section

New heading “Recent Developments”

New heading “Share Repurchase Plan”

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Removed text topics: penalt, covenant
“We are required to pay a quarterly commitment fee on any unused portion of the Revolving Credit Facility, letter of credit fees, and other customary fees to the Agent and the Lenders. The Term Loan Facility will amortize on a quarterly basis at 1.25% (for year one and two), 1.875% (for year three and four), and 2.5% (for year five) based on the aggregate principal amount outstanding under the Term Loan Facility at inception, with the remainder due on the Maturity Date. …”
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“On January 19, 2024, we entered into a Credit Agreement (the “Citizens Credit Agreement”) with a syndicate of banks comprised of Citizens Bank, N.A. as administrative agent (the “Agent”), and Bank of America, N.A. …”
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On January 19, 2024, we entered into a Credit Agreement (the “Citizens Credit Agreement”) with a syndicate of banks comprised of Citizens Bank, N.A. as administrative agent (the “Agent”), and Bank of America, N.A. The Citizens Credit Agreement provides for senior secured credit facilities in an aggregate principal amount of up to $95.0 million consisting of: (i) a $75.0 million senior secured revolving credit facility (the “Revolving Credit Facility”) with a $10.0 million letter of credit sublimit and a $10.0 million swingline loan sublimit, and (ii) a $20.0 million senior secured term loan facility (the “Term Loan Facility” and, together with the Revolving Credit Facility, the “Credit Facilities”). All obligations are required to be paid in full on January 19, 2029 (the “Maturity Date”), and are guaranteed by certain of our subsidiaries, and secured by substantially all of the assets of the Company and the guarantors pursuant to a customary security agreement. Subject to the terms of the Citizens Credit Agreement, we have the option to obtain one or more incremental term loan facilities and/or increase the commitments under the Revolving Credit Facility in an aggregate principal amount equal to the greater of (i) $50.0 million and (ii) 1.00 times the Company’s Consolidated EBITDA as defined therein, each subject to the existing or any new lenders’ election to extend additional term loans or revolving commitments..
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InterestNet interest income (expense) decreasedwas $5.5 million to $1.0$2.9 million for the year ended December 31, 20242025, fromcompared $6.5to $(1.0) million for the year ended December 31, 2023.2024. The decreasefavorable increase was theprimarily resultdriven ofby improved treasury management. a decreasereduction in outstanding debtdebt, and lower ratesinterest underrates. theAdditionally, Citizenswe Credit Facilities after the Debt Refinancing Transactions (as defined below) was completed in January 2024. Improvements in our treasury management further aided the decrease. This decrease was partially offset byrecorded a $1.4 million loss on extinguishment of debt due to repaying and terminating a previous loan agreement duringin the first quarter of 2024.2024 due to the repayment and termination of a previous loan agreement.
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“At our option, borrowings under the Citizens Credit Agreement (other than any swingline loan) will bear interest at a rate per annum equal to (i) the Alternate Base Rate, as defined therein, or (ii) a Term SOFR as defined therein, in each case plus an applicable margin ranging from 1.25% and 2.50% with respect to Alternate Base Rate borrowings and 2.25% and 3.50% for Term SOFR borrowings. Swingline loans will bear interest at a rate per annum equal to one-month Term SOFR plus the applicable margin. …”
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Added

During 2025, we delivered 20.0% growth in net sales, with broad-based contributions across Wound and Surgical. This growth was driven by a combination of demand for newer Wound products (CELERA™, EMERGE™ and EPIXPRESS®), increasing adoption of Surgical products across a growing number of use cases in the operating room and commercial execution. Operating and financial highlights during the year include:

Removed

During 2024, we delivered 8.5% growth in net sales, with broad-based contributions by customer type. This growth was driven by a combination of commercial execution and demand for newer products, despite ongoing Medicare reimbursement uncertainty for the private office and associated care settings as well as a higher than normal level of customer and employee turnover in the middle of the year. Operating and financial highlights during the year include:

Added

•Featured the Company’s growing body of clinical and scientific evidence at Wound & Surgical-focused industry conferences, including MedStar Georgetown University Hospital’s Diabetic Limb Salvage Conference, Symposium on Advanced Wound Care Spring and Fall meetings, and Digestive Disease Week 2025, among others.

Added

•Announced publication of health economics data in Mohs micrographic surgery

Added

•Entered into a strategic collaboration with Vaporox, Inc., establishing the ability for the Company to co-promote and co-market its leading placental allograft portfolio alongside Vaporox’s Vaporous Hyperoxia Treatment device

Added

•Launched EPIXPRESS® the Company’s next-generation, lyophilized human placental allograft, further expanding the Company’s broad portfolio of advanced wound care products

Added

•Announced interim results of its EPIEFFECT® randomized clinical trial, which were published and presented, demonstrating clinical benefit associated with use of EPIEFFECT® when compared to Standard of Care.

Added

•Announced publication in the Journal of Inflammation focused on the immunomodulatory effects of Purion® processed human amniotic membrane allografts in vitro. The study, which investigated the influence of MIMEDX DHACM and LHACM products on inflammatory response, demonstrated support of the healing cascade and tissue repair.

Added

•Entered into an exclusive U.S. distribution agreement for RegenKit®-Wound Gel with Regen Lab USA, LLC, continuing to broaden the Company’s leading Wound product offering beyond placental allografts.

Added

Additionally, at the end of 2025, CMS finalized sweeping changes related to the reimbursement of skin substitutes, which were implemented on January 1, 2026. These changes include: 1) reimbursing skin substitute products uniformly across the HOPD and physician office and associated care settings and 2) capping the reimbursement rate for skin substitutes at $127.14 per square centimeter in these care settings, subject to geographic adjustments. The specific policies were put into effect in the Physician Fee Schedule (“PFS”) and Hospital Outpatient Prospective Payment System (“OPPS”).

Removed

•Announced improved capital structure with new credit facilities that provide substantial interest savings over the Company’s prior indebtedness and access to additional capital in support of the Company’s strategic priorities

Removed

•Introduced e-commerce and account management platform, MIMEDX Connect, designed to streamline ordering, payment processing, and reimbursement submissions for our customers,

Removed

•Entered into an exclusive agreement providing the Company with rights to commercialize HELIOGEN, a 510(k) cleared, bovine-derived collagen matrix particulate that is indicated for the management of exudating wounds, which launched commercially during the second half of 2024

Removed

•Announced publication focused on surgical applications using MIMEDX placental-based allografts in Nature - Scientific Reports. The study adds to the Company’s growing body of evidence and expands the understanding of the regulatory capabilities of its DHACM and LHACM allografts on the fibrotic process

Removed

•Highlighted the publication of a feature article on placental allografts for patients with hard-to-heal, acute and chronic wounds, which was published in the New York Times: “Her Face Was Unrecognizable After an Explosion. A Placenta Restored It” On April 13, 2025, new LCDs are currently scheduled to go into effect which will modify the reimbursement of skin substitutes in physician office settings. Among other changes, many allografts that have been covered will no longer be reimbursed for DFUs and/or VLUs. While EPIFIX and EPICORD continue to be covered under the new LCD, certain of our other products are not currently included. In the past LCDs have been delayed or terminated so there is no guarantee they will go into effect in April 2025

Reworded

MIMEDX is a pioneer and leader in placental biologics focused on deliveringhelping innovativehumans solutions to patients and the healthcare professionals who treat them.heal. With morenearly thantwo a decadedecades of experience helping clinicians manage acutechronic and chronicother hard-to-heal wounds, MIMEDX has been dedicated to providingprovides a leading portfolio of products for applications in the wound care, burn, and surgical sectors of healthcare. All of our products sold in the United States are regulated by the FDA.U.S. Food and Drug Administration (“FDA”). We apply Current Good Tissue Practices (“CGTP”) and other applicable quality standards in addition to terminal sterilization to produce our allografts.

Added

Recent Developments

Added

On October 31, 2025, CMS issued the final update to Medicare reimbursement for skin substitutes, which was broadly in line with the initial proposed rate (the “2026 Rules”). Effective January 1, 2026, the 2026 Rules revolutionize skin substitute reimbursement by moving away from “Average Sales Price (ASP) +6%” model to a flat, standardized rate of $127.14 per square centimeter, cutting costs by nearly 90%. The change in policy to a flat rate is primarily driven to address skyrocketing expenditures – rising from ~$500 million in 2020 to ~$15 billion in 2025 (a nearly 40-fold increase) and to combat potential fraudulent billing, such as using larger-than-necessary grafts to maximize reimbursement.

Added

The increased spending, proliferation of Q-coded skin substitute products, and higher ASPs for these products have been under increased regulatory scrutiny over the last couple of years. In response to these market dynamics, CMS announced the 2026 Rules related to the reimbursement of skin substitutes. The changes under the 2026 Rules include: 1) reimbursing skin substitute products uniformly across the HOPD and physician office and associated care settings, 2) moving the reimbursement rate for skin substitutes from the “ASP+6%” methodology to a flat rate at $127.14 per square centimeter in these care settings, subject to geographic adjustments, and 3) reclassifying some products as “incident-to” supplies under the physician fee schedule and subject to a flat payment rate. This change applies to skin substitutes in three regulatory categories: (1) devices subject to premarket approval (PMA); (2) devices subject to 510(k) clearance; and (3) human cells, tissues and cellular and tissue-based products (HCT/Ps) regulated under Section 361 of the Public Health Service Act (the “PHS Act”). The 2026 Rules were put into effect in the Physician Fee Schedule (“PFS”) and Hospital Outpatient Prospective Payment System (“OPPS”).

Added

While there are many unknowns of the 2026 Rules, we may need to tighten inventory management, to minimize losses from expired or unused products and also revisit pricing strategies in light of the new reimbursement model. As to how the 2026 Rules impact clinical practice and physician behavior, it will only become clear as implementation progresses. We anticipate that the 2026 Rules will be a headwind to both Advanced Wound Management sales and profitability in 2026, before any mitigating actions.

Reworded

Our product portfolio is divided into two categories (1) Wound Care Products and (2) Surgical and Other Products.Surgical.

Added

Our Wound portfolio includes EPIFIX®, EPICORD®, EPIEFFECT®, EPIXPRESS®, CHORIOFIX™, EMERGE™, CELERA™, and RegenKit®-Wound Gel which are marketed for external use across a range of advanced wound applications. EMERGE™, CELERA™, and RegenKit®-Wound Gel are manufactured by third-party suppliers.

Added

Our Surgical portfolio includes AMNIOFIX®, AMNIOEFFECT®, AMNIOBURN®, AMNIOCORD®, AXIOFILL®, and HELIOGEN™, which are marketed for use in diverse surgical applications, including lower extremity repair, plastic and reconstructive surgery, vascular procedures, and multiple orthopedic repairs. HELIOGEN™ is manufactured by third-party supplier Regenity Biosciences, Inc. Additionally, in early 2026 we began distributing three additional Surgical Products: G4Derm Plus, NovaForm and Hydrelix to further expand our Surgical product offering.

Added

From time to time, we may acquire, manufacture, or market additional Wound or Surgical products in response to market demand or to maintain our competitive position.

Removed

The Wound Care products we manufacture include EPIFIX and EPIEFFECT, which are marketed for external use, such as in Advanced Wound Care applications. Within Surgical and Other, our product offering includes AMNIOFIX and AMNIOEFFECT, which are positioned for use in a variety of applications and surgical settings, including lower extremity repair, plastic surgery, vascular surgery and multiple orthopedic repairs and reconstructions. From time to time, we will also acquire, manufacture and market other products in the wound care, surgical or other products in response to market demands or to maintain our competitive position.

Removed

In 2024, we also launched HELIOGEN, a particulate xenograft product aimed at addressing complex wounds primarily in the surgical setting. HELIOGEN is a shelf-stable offering that contains Type I and Type III collagen and mimics the native composition of structural connective tissue, HELIOGEN is manufactured by Regenity Biosciences.

Reworded

Our net sales are derived from selling our Wound and Surgical products to a wide range of customers, including hospitals, wound care centers and private physician offices that have clinicians using our suite of products to aid in the management of patients with chronic or hard-to-heal wounds. These customers choose products like ours based upon a variety of factors, including clinical efficacy, customer engagement programs, availability, handling characteristics, and reimbursement coverage and payer sources. Net sales are recognized based on the consideration we expect to receive from the sale at the point in time when control of the goods is transferred to the customer, which generally occurs upon our delivery to a third-party carrier or implantation for consignment arrangements. Net sales consists of the gross selling price of the product, less any discounts, rebates and other customer incentives, fees paid to GPOs, and returns.

Added

Net sales are recognized based on the consideration we expect to receive from the sale at the point in time when control of the goods is transferred to the customer. For ship-and-bill sales, this occurs upon transfer of title to the customer. For consignment arrangements, this occurs upon implantation of the product on the end user . Net sales consists of the gross selling price of the product less any discounts, rebates and other customer incentives, fees paid to GPOs, and estimates for sales returns.

Reworded

Cost of goods sold includes product testing costs, quality assurance costs, personnel costs, manufacturing costs, raw materials and product costs, depreciationdepreciation, amortization of certain purchased assets and facility costs associated with our manufacturing and warehouse facilities. Fluctuations in our cost of goods sold correspond with the fluctuations in these costs as well as sales volume.

Added

Selling, general and administrative expense consists of both selling and marketing (“S&M”) and general and administrative (“G&A”) expenses.

Reworded

Selling, general and administrative expense consists of both selling and marketing (“S&M”) and general and administrative (“G&A”) expenses. S&Mexpense includes costs to execute our sales strategy, which includes personnel costs pertaining to our sales force and sales support functions, including salaries, commissions and other incentive compensation, commissions to sales agents, customer support, travel expenses, and bad debt expense. G&A expense reflects costs related to functions which support our business, such as legal, finance, human resources, and other such functions, including personnel costs associated with these functions, insurance, and certain professional fees. We expect our S&M expense to fluctuate based on revenue fluctuations, geographic changes, and any changes to the size of our headcount, particularly that of our sales and marketing forces. Certain of these costs scale with sales, but can fluctuate depending on sales mix. For example, we pay sales agents a greater commission than our internal sales force, meaning that we could incur greater commission expenses if a greater proportion of our sales are through sales agents. We expect our G&A expense to fluctuate based on headcount.

Added

G&A expense reflects costs related to functions which support our business, such as legal, finance, human resources, and other such functions. This includes personnel costs associated with these functions, insurance, and certain professional fees. We expect our G&A expense to fluctuate based on headcount.

Reworded

Research and development expense relates to our investments to expand our product pipeline and platforms, including historically through clinical trials,trials as well as expenditures in improvements to our manufacturing process and the enhancement of existing products. Our research and development costs also include expenses such as salaries and benefits related to our research department,departments, consulting costs andcosts, advisory costs, and regulatory costs.

Reworded

We expense research and development costs as incurred. Fluctuations in research and development expenses canare be impacteddriven by the timing and cadence of our clinical trials.

Reworded

Investigation, restatement and related expense primarily related to legal fees that were advanced to certain former officers and directors of the Company under certain indemnification agreements and our liability from certain legal proceedings that were taken against us. These costs ceasedended during the year ended December 31, 2024 and are not expected to reoccur.2024.

Reworded

Interest expense,income (expense), net

Reworded

We incur interest expense primarily throughfrom stated interest on our outstanding term loan and revolving loans,credit facilities, to the extent thatsuch theyborrowings are outstanding. The interestInterest on ourthese termfacilities and revolving loans areis currently tiedbased toon the applicable term Secured Overnight Financing RatesRate (“SOFR”)., Increasesand fluctuations in SOFR couldmay cause our interest expense to increase.vary. OtherWe activity influencinggenerate interest expense relates to the amortization of deferred financing costs and original issue discount associated with credit facilities outstanding. This amount is presented net of interest income, which we generateincome from ouramounts treasuryheld management.in various money market accounts.

Added

In addition, interest expense includes the amortization of deferred financing costs and original issue discounts associated with our credit facilities. This amount is presented net of interest income earned through our treasury management activities.

Added

We generate tax liability primarily in the United States and in various states in which we have nexus. The basis for our effective tax rate will generally approximate the United States’ federal statutory corporate tax rate (21%) plus a blended state rate, net of any federal benefit. Material deviations from this effective tax rate in each period is generally the result of the periodic effects of certain permanent differences between the book and tax treatment of certain transactions, including windfall or shortfall on vestings of restricted stock awards and limitations on the deduction of executive compensation. Historically, our effective tax rate was, and in the future may be, materially impacted by changes in our valuation allowance recorded against our deferred tax assets.

Removed

We generate tax liability primarily in the United States and in various states in which we have nexus. Across these jurisdictions, we have net operating losses, research and development tax credit carryforwards, and other deferred tax assets which materially defray our liability. Large fluctuations in our effective tax rate are generally driven by changes in our expectations of the realizability of our deferred tax assets. See “Critical Accounting Estimates” for further details. Our effective tax rate is also impacted by other permanent items, primarily executive compensation limitations and windfall or shortfall on the vesting of stock awards.

Added

Net sales in the Wound category were $276.3 million for the year ended December 31, 2025, a $45.3 million, or 19.6% increase, compared to $231.0 million for the year ended December 31, 2024. The increase was primarily driven by sales of the higher priced products EMERGE™, CELERA™, and EPIXPRESS®, partially offset by ongoing commercial challenges and regulatory pressures on pricing and reimbursement, which were consistent with those experienced in the prior year.

Added

Net sales in the Surgical category grew by $24.4 million, or 20.7%, to $142.3 million for the year ended December 31, 2025, compared to $117.9 million for the year ended December 31, 2024. The increase was primarily driven by sales of AMNIOFIX®, AMNIOEFFECT®, and HELIOGEN® across a range of surgical procedures.

Removed

Net sales in the Wound category were $231.0 million for the year ended December 31, 2024, a $25.3 million, or 12.3% increase, compared to $205.7 million for the year ended December 31, 2023. The increase was primarily driven by sales of EPIEFFECT, partially offset by commercial challenges associated with competitive behavior in the marketplace as well as headwinds relating to turnover of certain of our sales team and customers.

Removed

Net sales in the Surgical category grew by $2.1 million, or 1.8%, to $117.9 million for the year ended December 31, 2024, compared to $115.8 million for the year ended December 31, 2023. The increase reflects growing sales volume contributions from AMNIOEFFECT, partially offset by lower AXIOFILL compared to the prior year due to regulatory headwinds. In addition, Surgical sales for the year ended December 31, 2023 reflects $3.3 million of sales of our dental product which we have since discontinued.

Reworded

Gross margin in 20242025 was 82.8%,82.6%, compared to 83.0%82.8% in 2023.2024. The decreaseslight in margindecline was driven by thelower amortizationyield, ofand variousmanufacturing intangibleinefficiencies. assetsThese acquiredpressures duringwere 2024. This effect waspartially offset by a more favorable product mixmix, andreflecting oura continuedgreater executionproportion onof scraphigher-price improvementproducts projects,in partiallythe offsetsales by throughput pressures.portfolio.

Reworded

Cost of sales for the year ended December 31, 20242025 was $60.1$73.0 million, an increase of $5.4$12.9 million, or 10.0%,21.5%, compared to $54.6$60.1 million for the year ended December 31, 2023.2024. The increase in cost of sales was driven by the increase inhigher sales volumevolume, and theincreased changesmanufacturing in margins noted above.inefficiencies.

Reworded

SG&A expense increased $14.0$41.1 million, or 6.6%,18.3%, to $266.2 million for December 31, 2025, compared to $225.1 million for December 31, 2024, compared to $211.1 million for December 31, 2023.2024. The following table shows the composition of this expense between selling and marketing (“S&M”) and general and administrative (“G&A”) components (amounts in thousands):

Reworded

Sales and marketing expenses increased $13.7$34.1 million, or 8.5%,19.4%, year over year, which was driven by increases in commissionsprimarily due to higher commissions driven by increased sales and higherelevated effective commission rates.rates, along with higher bad debt expense. General and administrative expense increased $0.2$7.0 million, or 0.5%,14.1%, year-over-year. The increase wasyear-over-year, driven by generalongoing increaseslegal inand salariesregulatory fromdisputes, merittransaction-related increases,costs, offset by reductions inand severance expense and professional services.costs.

Added

Our research and development (“R&D”) expense was $15.1 million for the year ended December 31, 2025, compared to $12.3 million for the year ended December 31, 2024. The increase was driven by on-going clinical trials and research studies aimed at strengthening clinical and economic evidence.

Removed

Our research and development (“R&D”) expense was $12.3 million for the year ended December 31, 2024, compared to $12.7 million for the year ended December 31, 2023. The decrease in R&D expense related to the timing of our product development activities, which primarily related to EPIEFFECT in 2023.

Reworded

Investigation, restatement, and related expenses for the year ended December 31, 2024 was a benefit of $8.7 million, compared to expense of $5.2 million for the year ended December 31, 2023.million. The benefit was resulted from various settlements related to former officers and other related matters during 2024. This was offset by the last material payment towards the resolution of matters stemming from the findings of our historical Audit Committee investigationinvestigation. duringThese theexpenses year ended December 31, 2024. We do not expect activity to be materialceased in future periods.2024.

Reworded

Amortization expense related to intangible assets werefor the year ended December 31, 2025 was $0.4 million, compared to $0.8 million for each of the yearsyear ended December 31, 2024 and 2023.2024.

Reworded

ImpairmentThere was no impairment for the year ended December 31, 20242025, wascompared to $0.4 million,million whichfor relatesthe year ended December 31, 2024. The impairment of intangible assets in 2024 related to abandoned patents.

Reworded

Interest Expense,Income (Expense), Net

Reworded

InterestNet interest income (expense) decreasedwas $5.5 million to $1.0$2.9 million for the year ended December 31, 20242025, fromcompared $6.5to $(1.0) million for the year ended December 31, 2023.2024. The decreasefavorable increase was theprimarily resultdriven ofby improved treasury management. a decreasereduction in outstanding debtdebt, and lower ratesinterest underrates. theAdditionally, Citizenswe Credit Facilities after the Debt Refinancing Transactions (as defined below) was completed in January 2024. Improvements in our treasury management further aided the decrease. This decrease was partially offset byrecorded a $1.4 million loss on extinguishment of debt due to repaying and terminating a previous loan agreement duringin the first quarter of 2024.2024 due to the repayment and termination of a previous loan agreement.

Reworded

Our effective tax rates for 20242025 and 20232024 waswere 26.7% and (120.2)%,26.7%, respectively, on income from continuing operations before income tax provision of $57.3$66.3 million and $30.6$57.3 million for 20242025 and 2023,2024, respectively. The effective tax rate in each period was favorably impacted by vestings of restricted stock, offset by executive compensation deduction limitations.

Added

The income tax provision for the year ended December 31, 2025 reflects the provisions of the One Big Beautiful Bill Act (“OB3”). OB3 resulted in a current tax benefit resulting from the utilization of deferred tax assets, primarily relating to the utilization of capitalized research and development expenses, and did not affect our effective tax rate in the year ended December 31, 2025.

Removed

Our effective tax rate in 2024 was favorably impacted by vestings of restricted stock, offset by executive compensation deduction limitations.

Removed

Our effective tax rate for the year ended December 31, 2023 was significantly impacted by the reversal of a valuation allowance. In the period, the Company noted that it was no longer in a cumulative three-year loss on a continuing operations basis, after excluding the effects of permanent book-tax differences. The absence of such negative evidence, coupled with our expectation for future taxable income generation, led to a change in our assessment of the realizability of our deferred tax assets.

Reworded

TheWe Company isare currently paying itsour obligations in the ordinary course of business. We believe that our anticipated cash from operating activities, existing cash and cash equivalents, and available credit under the Citizens Credit Agreement, as defined below, will enable us to meet our operational liquidity needs for the twelve months following the filing date of this Annual Report.

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What changed in the latest 10-Q

Comparing 10-Q filed 2026-07-29 (period ending 2026-06-30) with 10-Q filed 2026-04-29 (period ending 2026-03-31).

Risk Factors (10-Q Part II, Item 1A)

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There have been no material changes to the Company’s risk factors included in the 2025 Form 10-K.

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Management's Discussion & Analysis (MD&A) (10-Q Part I, Item 2)

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Added

During the second quarter of 2026, we continued to execute our strategic priorities, including expanding our Surgical portfolio, launching new products, advancing recent cost reduction initiatives, and returning capital to shareholders through our Share Repurchase Plan. These efforts contributed to continued growth in the Surgical business, which demonstrated a sixth consecutive quarter of double-digit year-over-year growth.

Added

•Net sales were $64 million, a decrease of 35% compared to the prior year period, driven by a 61% decline in Wound sales, partially offset by 15% growth in Surgical sales. Surgical growth was driven by continued adoption of AMNIOFIX®, AMNIOEFFECT®, and our particulate portfolio, as well as contributions from the Company’s distribution agreement with Summit Products Group, namely G4Derm® Plus.

Added

•We reported a GAAP net loss of $15 million or $0.10 per diluted share, and ended the quarter with $136 million of cash and cash equivalents.

Added

•During the quarter, we completed a reduction-in-force and implemented additional cost reduction initiatives designed to align our cost structure with current business needs and support operating efficiency.

Added

•Separately, we repurchased approximately $13 million of common stock under our Share Repurchase Plan, reflecting our continued commitment to disciplined capital allocation and delivering long-term shareholder value.

Removed

During the first quarter of 2026, the Company delivered the following financial results:

Removed

•Net sales of $59 million, reflecting a 33% decrease over the prior year period. which was comprised of:

Removed

◦Surgical net sales of $36 million, reflecting an increase of 13% compared to the prior year period; and ◦Wound net sales of $23 million, reflecting a decrease of 60% compared to the prior year period

Removed

•GAAP net loss and net loss margin for the first quarter of 2026 of $11 million and 18%, respectively.

Removed

•GAAP fully diluted earnings per share for the first quarter of 2026 of $(0.07) compared to $0.05 in the prior year period.

Removed

•Cash balance of $160 million, representing a $6 million decrease sequentially and a $53 million increase compared to March 31, 2025.

Removed

Additionally during the quarter, the Company launched two new organically developed products, AMNIOFIX® Thyroid Shields and CHORIOFIX™ and entered into an exclusive distribution agreement with Summit Products Group for multiple additional Surgical products, namely G4Derm® Plus, Hydrelix Collagen Matrix and Novaform®.

Reworded

This discussion, which presents our results for the three and six months ended MarchJune 31,30, 2026 and 2025, should be read in conjunction with the unaudited condensed consolidated financial statements and accompanying notes included in this Form 10-Q and the financial statements and accompanying notes and Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 filed with the SEC on February 25, 2026 (the “2025 Form 10-K”).

Reworded

Three Months Ended MarchJune 31,30, 2026 Compared to the Three Months Ended MarchJune 31,30, 2025

Reworded

Net sales were $59.0$64.4 million for the three months ended MarchJune 31,30, 2026, representing a decrease of $29.2$34.2 million, or 33.1%,34.7%, compared to $88.2$98.6 million for the three months ended MarchJune 31,30, 2025.

Reworded

Surgical net sales were $36.4$39.3 million for the three months ended MarchJune 31,30, 2026, representing an increase of $4.2$5.2 million, or 13.2%,15.1%, compared to $32.1$34.1 million for the three months ended MarchJune 31,30, 2025. This increase was primarily driven by continued growth acrossin the AMNIOFIX®, AMNIOEFFECT®, AXIOFILL®, and HELIOGEN™AMNIOEFFECT productsheet lines as adoption expanded across multiple surgical procedures.products.

Added

Wound net sales were $25.1 million for the three months ended June 30, 2026, representing a decrease of $39.4 million or 61.1%, compared to $64.5 million for the three months ended June 30, 2025. This decline was primarily driven by the continued impact of Medicare reimbursement changes effective January 1, 2026, which adversely affected both pricing and sales volumes for these products.

Removed

Wound net sales were $22.6 million for the three months ended March 31, 2026, representing a decrease of $33.5 million or 59.7%, compared to $56.1 million for the three months ended March 31, 2025. This decline was primarily driven by the Medicare reimbursement changes that went into effect on January 1, 2026, which resulted in reduced reimbursement rates for skin substitute products, created administrative barriers for patients to receive these products and led to lower realized pricing and volumes within the Wound Care business. During the quarter, the Company also saw initial contributions from sales of its RegenKit PRP offering.

Reworded

Cost of sales were $17.4$20.0 million for the three months ended MarchJune 31,30, 2026, representing an increase of $0.8$1.3 million, or 4.9%.7.0%. compared to $16.6$18.7 million for the three months ended MarchJune 31,30, 2025. This increase was primarily driven by higherincreased productionsales volume and one-time expenses related to our cost andreduction increased volume in the Surgical business, largely offset by lower volume in the Wound Care business and reduced amortization of acquired intangible assets.initiative.

Reworded

Gross profit margin was 70.6%69.0% for the three months ended MarchJune 31,30, 2026, compared to 81.2%81.1% for the three months ended MarchJune 31,30, 2025. This decline was primarily driven by lower pricing in the Wound Care pricingbusiness following the Medicare reimbursement changes, as well as unfavorable product mixchanges and higher manufacturing costs.

Reworded

Selling, general and administrative (“SG&A”) expense was $53.2$59.8 million for the three months ended MarchJune 31,30, 2026, compared to $60.0$64.2 million for the three months ended MarchJune 31,30, 2025. The following table shows the composition of this expense between selling and marketing (“S&M”) and general and administrative (“G&A”) components (amounts in thousands):

Reworded

Sales and marketing expenses decreased $2.9$1.5 million or 6.3%,3.0%, year over year, primarily driven by lower commissionpersonnel, travel, and meeting expense resulting from reducedour salesrecent andcost reduction initiative, as well as lower travelcommission andexpense meetingdriven expenses.by Thisreduced decreasesales. wasThese partiallydecreases were offset by higher bad debt expense.expense, which increased $5.0 million, year over year. This increase is associated with the credit deterioration of certain legacy customers.

Reworded

General and administrative expenses decreased $3.8$2.9 million or 28.9%17.9% year over year, primarily due to thelower personnel expense resulting from our recent cost reduction ofinitiative. compensation-relatedThis costs,decrease primarilywas related to the reversal of stock-based compensation expense associated with outstanding performance stock unit awards. These savings were largelypartially offset by increased legal and regulatory expenses, including costexpense associated with the ongoing litigationlegal with certain competitors and certain former employees.matters.

Reworded

Research and development (“R&D”) expense was $4.1$2.8 million for the three months ended MarchJune 31,30, 2026, representing ana increasedecrease of $0.8$0.5 million, or 24.4%,15.9%, compared to $3.3 million for the three months ended MarchJune 31,30, 2025. This increasedecrease was primarily driven by highercompletion of patient activities in our EPIEFFECT study and the results of our cost reduction initiative. These impacts were offset by costs associatedincurred withtoward theour ongoing510(k) EPIEFFECT randomized clinical trial, as well as continued investment in the development of future products within the Company’s pipeline.submissions.

Reworded

Interest income, net was $0.9$0.8 million for the three months ended MarchJune 31,30, 2026, representing an increase of $0.4$0.1 million or 75.1%6.8% compared to $0.5$0.7 million for the three months ended MarchJune 31,30, 2025. ThisThe increase was primarily driven by higher average cash balances maintained in the Company’s interest-bearing accounts and a reduction in outstanding debt. These impacts were offset by lower market interest rates.

Reworded

The effective tax rates for the Company were 29.2%16.5% and 18.5%26.1% for the three months ended MarchJune 31,30, 2026 and MarchJune 31,30, 2025, respectively.

Added

Note that we generated pre-tax loss for the three months ended June 30, 2026, meaning that decreases in our effective tax rate would be unfavorable for that period. Conversely, we generated pre-tax income for the three months ended June 30, 2025, meaning that decreases in our effective tax rate would favorable for that period.

Added

The effective tax rate for the three months ended June 30, 2026 was unfavorably impacted due to deduction limitations on executive compensation, in part resulting from one-time costs associated with our recent cost reduction initiative. Shortfall on restricted stock vestings further contributed to the unfavorability.

Reworded

The increase in the effective tax rate for the three months ended MarchJune 31,30, 20262025 was primarilyfavorably dueimpacted toby thewindfall timingon ofrestricted stock-basedstock compensationvestings. adjustments,This partiallywas offset by limitsdeduction limitations on the deductibility of executive compensation.

Added

Six Months Ended June 30, 2026 Compared to the Six Months Ended June 30, 2025

Added

Changes noted as “nm” in the table above indicate that the percentage change is not meaningful.

Added

Net Sales

Added

Net Sales were $123.4 million for the six months ended June 30, 2026, representing a decrease of $63.5 million, or 34.0%, compared to $186.8 million for the six months ended June 30, 2025.

Added

Sales by product category were as follows (amounts in thousands):

Added

Surgical net sales were $75.7 million for the six months ended June 30, 2026, representing an increase of $9.4 million, or 14.2%, compared to the six months ended June 30, 2025. This increase was primarily driven by continued growth in the AMNIOFIX and AMNIOEFFECT sheet products.

Added

Wound net sales were $47.7 million for the six months ended June 30, 2026, representing a decrease of 72.9 million or 60.4%, compared to the six months ended June 30, 2025. This decrease was primarily driven by the continued impact of Medicare reimbursement changes which adversely affected both pricing and sales volumes for these products.

Added

Cost of Sales and Gross Profit Margin

Added

Cost of sales were $37.3 million for the six months ended June 30, 2026, representing an increase of $2.1 million, or 6.0%, compared to $35.2 million for the six months ended June 30, 2025. This increase was primarily driven by increased sales volumes and one-time expenses related to our cost reduction initiative.

Added

Gross profit margin was 69.7% for the six months ended June 30, 2026 compared to 81.1% for the six months ended June 30, 2025. This decline was driven by lower pricing in the Wound business following the Medicare reimbursement changes and higher manufacturing costs.

Added

Selling, General and Administrative Expense

Added

Selling, general and administrative expense was $113.0 million for the six months ended June 30, 2026, compared to $124.1 million for the six months ended June 30, 2025. The following table shows the composition of this expense between selling and marketing (“S&M”) and general and administrative (“G&A”) components (amounts in thousands):

Added

Sales and marketing expenses decreased $4.4 million or 4.6%, year over year, primarily driven by lower personnel, travel, and meeting expense resulting from our recent cost reduction initiative as well as lower commission expense driven by reduced sales. These decreases were partially offset by bad debt expense, which increased $5.6 million, year over year. This increase is associated with the credit deterioration of certain legacy customers.

Added

General and administrative expenses decreased $6.7 million or 22.8%, year over year, primarily due to the reversal of stock-based compensation expense associated with unvested performance stock unit awards and lower personnel costs. These savings were partially offset by increased legal xpense associated with ongoing legal matters

Added

Research and Development Expense

Added

Research and development (“R&D”) expense was $6.9 million for the six months ended June 30, 2026, compared to $6.6 million for the six months ended June 30, 2025. This increase was primarily driven by costs associated with increased enrollment for the EPIEFFECT® randomized controlled trial. These increases were partially offset by lower personnel costs associated with our recent cost reduction activities.

Added

Interest Income, Net

Added

Interest income, net was $1.7 million for the six months ended June 30, 2026 compared to interest income, net of $1.2 million for the six months ended June 30, 2025, an increase of $0.4 million, or 34%. The increase was driven by higher average cash balances maintained in the Company’s interest-bearing accounts and a reduction in outstanding debt.

Added

Income Tax Provision

Added

The effective tax rates for the Company were 22.4% and 23.0% for the six months ended June 30, 2026 and 2025, respectively.

Added

Note that we generated pre-tax loss for the six months ended June 30, 2026, meaning that decreases in our effective tax rate would be unfavorable for that period. Conversely, we generated pre-tax income for the six months ended June 30, 2025, meaning that decreases in our effective tax rate would favorable for that period.

Added

The effective tax rate for the six months ended June 30, 2026 was unfavorably impacted by deduction limitations on executive compensation, in part resulting from one-time costs associated with our recent cost reduction initiative. Shortfall on restricted stock vestings further contributed to the unfavorability.

Added

The effective tax rate for the six months ended June 30, 2025 was favorably impacted by windfall on restricted stock vestings. This favorability was offset by the deduction limitations on executive compensation.

Reworded

Cash generatedused byin operating activities was $1.9$8.1 million during the threesix months ended MarchJune 31,30, 2026, representing a decrease of $3.4$27.9 million, compared to $5.3cash provided by operating activities of $19.7 million for the threesix months ended MarchJune 31,30, 2025. This decrease was primarily drivenattributable byto lower netcash income,collections associated with reduced sales, annual incentive compensation payments made during the first quarter of 2026, and cost reduction initiative-related severance payments made during the second quarter of 2026. These impacts were partially offset by significantlower accountsoperating receivableexpenditures collections.resulting from the Company’s ongoing cost reduction initiative.

Reworded

Cash used for investing activities was $5.6$6.3 million during the threesix months ended MarchJune 31,30, 2026, compared to $0.4$1.3 million for the threesix months ended MarchJune 31,30, 2025. This increase reflects a $5.0 million payment to acquire exclusive distribution rights for RegenKit®‑Wound Gel.

Reworded

Cash used for financing activities was $2.6$15.9 million during the threesix months ended MarchJune 31,30, 2026, compared to $2.9$4.0 million for the threesix months ended MarchJune 31,30, 2025. CashThis used during both periodsincrease was primarily drivenattributable byto repurchases of common stock repurchasesunder tothe satisfyCompany’s taxShare withholdingRepurchase obligationsPlan, uponincluding vesting$12.5 million of employeecash equitypaid awards,for arepurchases during the second quarter of 2026, higher principal paymentpayments under the Citizens Credit Agreement, and aincreased profit-share paymentpayments to TELA Bio, Inc. related to HELIOGEN® salessales. performance.These increases were partially offset by lower share repurchases related to employee tax withholding obligations associated with the vesting of equity awards.

Reworded

As of MarchJune 31,30, 2026, we had $159.8$135.8 million of cash and cash equivalents, total current assets of $240.3$205.4 million and total current liabilities of $44.6$38.5 million. We had $17.6$17.3 million of long term debt outstanding and $75.0 million of availability under our Revolving Credit Facility (as discussed below).Facility.

Reworded

On January 19, 2024, the Company entered into the Citizens Credit Agreement, which provided the Company with a $75.0 million Revolving Credit Facility and $20.0 million Term Loan Facility. We had no outstanding borrowings under the Revolving Credit Facility facility as of MarchJune 31,30, 2026. The Term Loan Facility matures on January 19, 2029.

Reworded

As of MarchJune 31,30, 2026, the Company has $17.6$17.3 million of principal outstanding on the Term Loan Facility that bears interest at 6.0% and no borrowings outstanding under the Revolving Credit Facility.

Added

Share Repurchase Plan

Added

In February 2026, our Board of Directors (the “Board”) authorized us to periodically repurchase up to $100.0 million of our outstanding common stock (the “Share Repurchase Plan”) through February 2028. The timing and amount of repurchases, if any, will depend on a number of factors, including capital requirements for inorganic business development, market conditions, our financial condition, operating results, and other business considerations. Notwithstanding the Share Repurchase Plan, management’s focus remains on executing on our strategic initiatives, including inorganic growth investments. The Share Repurchase Plan does not obligate us to repurchase any shares.

Showing the first 60 of 74 changed paragraphs. The complete comparison will be part of Pro (coming soon). Meanwhile you can read the full text in the original filing.

MDXG insider buying and selling (Form 4)

Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.

Trade dateInsiderTransactionSharesPriceValueOwned afterFiling
2026-07-02Doug Rice
Chief Financial Officer
Shares withheld for tax 12,749$3.95 $50.4K399,566 SEC
2026-06-24Maersk-Moller Kimberly
Chief Commercial Officer
Shares withheld for tax 19,820$3.83 $75.9K309,630 SEC
2026-06-10Bierman James L
Director
Grant/award 50,913$3.64 $185.3K263,684 SEC
2026-06-10Puhy Dorothy E
Director
Grant/award 50,913$3.64 $185.3K108,510 SEC
2026-06-10Newton Todd
Director
Grant/award 50,913$3.64 $185.3K463,684 SEC
2026-06-10Hawkins William A
Director
Grant/award 50,913$3.64 $185.3K254,931 SEC
2026-06-10Olson Tiffany
Director
Grant/award 50,913$3.64 $185.3K108,510 SEC

Well-known investors holding MDXG (13F)

InvestorQuarterSharesReported value% of their 13FChange vs prior quarter
AQR Capital Management (Cliff Asness) COM2026-06-302,467,005$9.5M0.0%Added 170%
Renaissance Technologies COM2026-06-302,444,230$9.4M0.01%Reduced 19%
Citadel Advisors (Ken Griffin) COM2026-06-30825,838$3.2M0.0%Added 6%
D. E. Shaw & Co. COM2026-06-30421,367$1.6M0.0%Added 35%
Two Sigma Investments COM2026-06-30246,625$949.5K0.0%Reduced 8%
Millennium Management (Israel Englander) COM2026-06-30200,487$791.9K—Sold out
Point72 Asset Management (Steve Cohen) COM2026-06-30123,557$475.7K0.0%Reduced 42%

13F reports are filed up to 45 days after quarter end and show long U.S. equity positions only; options positions are omitted here.

Coming soon: email alerts when MDXG files, watchlists and downloadable comparisons.