MIMEDX GROUP INC

Risks Related to Our Business and Industry

•If we do not successfully execute our priorities, our business, operating results and financial condition could be adversely affected.

•We are in a highly competitive and evolving field and face competition from well-established tissue processors and medical device manufacturers, as well as new market entrants.

•Rapid technological change could cause our products to become obsolete.

•Many of our products depend on the availability of tissue from human donors, and any disruption in supply could adversely affect our business.

•We depend on our senior leadership team and key employees and may not be able to retain or replace these employees or recruit additional qualified personnel.

•Our revenues depend on adequate reimbursement from public and private insurers and health systems and changes to the way in which our products are reimbursed in various sites of service could adversely impact our financial results.

•Our revenue, results of operations and cash flows may suffer upon the loss of a Group Purchasing Organization or Integrated Delivery Network.

•We contract with and are dependent on independent sales agents and distributors.

•Disruption of our processing facilities could adversely affect our business, financial condition and results of operations.

•To be commercially successful, we must educate physicians, where appropriate, how and when our products are proper alternatives to existing treatments and that our products should be used in their procedures.

•If we cannot successfully address quality issues that may arise with our products, our brand reputation could suffer, and our business, financial condition, and results of operations could be adversely impacted.

•The formation of physician-owned distributorships could result in increased pricing pressure on our products or harm our ability to sell our products to physicians who own or are affiliated with those distributorships.

•We face the risk of product liability claims and may not be able to obtain or maintain adequate product liability insurance.

•The products we offer are derived from human and animal tissue and therefore have the potential for disease transmission.

•We may implement a product recall or voluntary market withdrawal.

•A cyberattack or significant disruptions of information technology systems could adversely affect our business.

•We may expand or contract our business through acquisitions, divestitures, licenses, investments, and other commercial arrangements.

•A portion of our revenues and accounts receivable come from government accounts.

•Our international expansion and operations outside the U.S. expose us to risks.

Risks Related to Regulatory Approval of Our Products and Other Government Regulations

•The FDA has in the past determined, and may in the future determine, that certain of our products that are, or are derived from, human cells or tissues, do not qualify for regulation solely under Section 361 of the Public Health Service Act (“Section 361”), and may require that we revise our labeling and marketing claims for these products or that we suspend sales of such products until FDA pre-market clearance or approval is obtained, which could adversely affect our business, results of operations, and financial condition.

•Obtaining and maintaining the necessary regulatory approvals, including conducting clinical trials, for certain of our products will be expensive and time consuming and may impede our ability to fully exploit our technologies.

•Our business is subject to extensive regulation by the FDA and other authorities, which is costly.

•We may be subject to fines, penalties, injunctions and other sanctions if we are deemed to be promoting the use of our products for unapproved, or off-label, uses.

•We and our sales representatives must comply with various federal and state anti-kickback, self-referral, false claims and similar laws.

•Our results of operations may be adversely affected by current and potential future healthcare reforms.

•We may fail to obtain or maintain foreign regulatory approvals to market our products in other countries.

•Federal, state, and international laws that protect the privacy and security of personal information may increase our costs and limit our ability to collect and use that information and subject us to liability.

Risks Related to Our Intellectual Property

•Our ability to protect our intellectual property and proprietary technology through patents and other means is uncertain and may be inadequate.

•We may become subject to claims of infringement of the intellectual property rights of others.

•We may be subject to damages resulting from claims that we, our employees, or our independent contractors have wrongfully used or disclosed alleged trade secrets, proprietary or confidential information of our competitors or are in breach of non-competition or non-solicitation agreements with our competitors.

Risks Related to Our Consolidated Financial Statements, Internal Controls and Related Matters

•If we fail to maintain adequate internal control over financial reporting in the future, this could adversely affect our business, financial condition and operating results.

•The restrictive covenants in the Citizens Credit Agreement, and the Company’s obligation to make payments under the Citizens Credit Agreement, limit our operating and financial flexibility.

•EW Healthcare Partners and its interests may conflict with those of our other shareholders.

•The price of our Common Stock has been, and will likely continue to be, volatile.

•Securities analysts may elect not to report on our common stock or may issue negative reports that adversely affect the stock price.

•Fluctuations in revenue or results of operations could cause additional volatility in our stock price.

•We do not intend to pay cash dividends on our Common Stock.

•Certain provisions of Florida law and anti-takeover provisions in our organizational documents may discourage or prevent a change of control.

Estimates and Projections

This discussion includes certain estimates, projections and other statistical data. These estimates and projections reflect management’s best estimates based upon currently available information and certain assumptions we believe to be reasonable. These estimates are inherently uncertain, subject to risks and uncertainties, many of which are not within our control, have not been reviewed by our independent auditors and may be revised as a result of management’s further review. In addition, these estimates and projections are not a comprehensive statement of our financial results, and our actual results may differ materially from these estimates and projections due to developments that may arise between now and the time the results are final. There can be no assurance that the estimates will be realized, and our results may vary significantly from the estimates, including as a result of unexpected issues in our business and operations. Accordingly, you should not place undue reliance on such information. Projections, assumptions and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk. See Item 1A, Risk Factors for further information.