| --- | --- | --- | |------------------------------------------------------------|-------------------------------|-------| | | | | | | | | | MiMedx | | | | ADVANCED PLACENTAL SCIENCE March 9-10, 2021 | INNOVATING TREATMENTS THROUGH | | | 2021 H.C. Wainwright & Co. Global Life Sciences Conference | | | IMPORTANT CAUTIONARY STATEMENT This presentation contains forward-looking statements. Actual results may differ materially. Investors are cautioned against placing undue reliance on these statements, All state ...

MiMedx Group, Inc. (NASDAQ:MDXG) Q4 2020 Earnings Conference Call March 8, 2021 9:30 AM ET Company Participants Jack Howarth - VP of IR and Corporate Communications Tim Wright - CEO Pete Carlson - CFO Robert Stein - EVP, Research & Development Rohit Kashyap - EVP and Chief Commercial Officer Conference Call Participants Sean Kang - H.C. Wainwright John Vandermosten - SIC Zacks Eiad Asbahi - Prescience Point Operator Ladies and gentlemen, thank you for standing by, and welcome to the MiMedx Fourth Quarter 20 ...

Part I [Business](index=8&type=section&id=Item%201.%20Business) MiMedx specializes in placental tissue allografts for wound care and musculoskeletal conditions, navigating FDA reclassification of key products to Section 351 biologics requiring BLA approval - MiMedx is a leader in placental biologics, with a core business in advanced wound care and a late-stage pipeline for degenerative musculoskeletal conditions[21](index=21&type=chunk)[43](index=43&type=chunk) - The company's products are derived from human placental tissues using the proprietary PURION® process, and include platform technologies like AmnioFix®, EpiFix®, and EpiCord®[21](index=21&type=chunk)[23](index=23&type=chunk) - A 2017 FDA guidance reclassified certain products, such as micronized AmnioFix Injectable, as Section 351 biologics requiring BLA approval, moving away from the less stringent Section 361 HCT/P regulation[24](index=24&type=chunk)[25](index=25&type=chunk) - The FDA has granted an enforcement discretion period until May 31, 2021, allowing MiMedx to continue marketing these products while pursuing the necessary BLA approvals[26](index=26&type=chunk)[28](index=28&type=chunk) Revenue from Products Potentially Affected by End of FDA Enforcement Discretion | Product Category | 2020 Revenue | Percentage of Total Revenue | | :--- | :--- | :--- | | Micronized Products & AmnioFill | $32.8 million | ~13% | | Umbilical Cord-Derived Products | $16.6 million | N/A | - The company is actively conducting late-stage clinical trials for AmnioFix Injectable under three Investigational New Drug (IND) applications for plantar fasciitis (Phase 3), Achilles tendonitis (Phase 3), and knee osteoarthritis (Phase 2B)[29](index=29&type=chunk)[52](index=52&type=chunk)[70](index=70&type=chunk) [Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including regulatory reclassification of products, material weaknesses in financial controls, ongoing litigation, and intense market competition - A primary regulatory risk is that products like micronized and umbilical cord-derived tissues may not qualify for regulation solely under Section 361, potentially requiring their removal from the market after the FDA's enforcement discretion period expires, which would materially impact revenue[192](index=192&type=chunk)[195](index=195&type=chunk)[196](index=196&type=chunk) - The company has identified and is remediating material weaknesses in its internal control over financial reporting, which could lead to misstatements and affect investor confidence[243](index=243&type=chunk)[244](index=244&type=chunk) - MiMedx faces substantial litigation and investigation risks related to a prior Audit Committee investigation and financial restatement, which could result in significant legal expenses and harm to the business[248](index=248&type=chunk)[249](index=249&type=chunk) - The business is highly competitive, faces risks from rapid technological change, and depends on the availability of human donor tissue, which could be disrupted[150](index=150&type=chunk)[151](index=151&type=chunk)[154](index=154&type=chunk) - The company's substantial indebtedness under the Hayfin Loan Agreement includes restrictive covenants that limit operational and financial flexibility[251](index=251&type=chunk)[252](index=252&type=chunk) - Holders of Series B Preferred Stock have preferential rights to dividends and liquidation distributions, voting rights, and conversion features that could dilute the value of common stock[257](index=257&type=chunk)[259](index=259&type=chunk)[266](index=266&type=chunk) [Unresolved Staff Comments](index=67&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved comments from the SEC Staff regarding its filings - As of the filing date, MiMedx has no unresolved staff comments from the Securities and Exchange Commission (SEC)[274](index=274&type=chunk) [Properties](index=67&type=section&id=Item%202.%20Properties) The company's primary operations are in leased facilities in Georgia, with ongoing investments to enhance manufacturing capacity and CGMP compliance - The company's corporate headquarters and primary operations are located in leased facilities in Marietta and Kennesaw, Georgia[275](index=275&type=chunk) - MiMedx is investing in its manufacturing capacity to enhance compliance with CGMP standards for its products[276](index=276&type=chunk) [Legal Proceedings](index=68&type=section&id=Item%203.%20Legal%20Proceedings) Details on legal proceedings, regulatory matters, and contingencies are incorporated by reference from Note 14 of the financial statements - For details on legal proceedings, the company refers to Note 14, "Commitments and Contingencies," in its financial statements[277](index=277&type=chunk) [Mine Safety Disclosures](index=68&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's business operations - The company has no mine safety disclosures to report[278](index=278&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=68&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on Nasdaq, has not paid dividends, and repurchased shares in Q4 2020 primarily for tax withholding obligations - The company's common stock is traded on the Nasdaq under the symbol "MDXG"[280](index=280&type=chunk) - MiMedx has never paid cash dividends on its common stock and does not plan to in the foreseeable future[280](index=280&type=chunk) Q4 2020 Equity Repurchases | Period | Total Shares Purchased | Average Price Paid per Share | | :--- | :--- | :--- | | Oct 2020 | 15,031 | $6.04 | | Nov 2020 | 56,543 | $5.78 | | Dec 2020 | 36,833 | $7.68 | | **Total Q4** | **108,407** | **$6.46** | [Selected Financial Data](index=70&type=section&id=Item%206.%20Selected%20Financial%20Data) Selected consolidated financial data shows declining net sales and recurring net losses over the past three years, alongside growth in total assets and a shift to a stockholders' deficit Selected Statement of Operations Data (in thousands, except per share data) | Year | Net Sales | Gross Profit | Operating (Loss) Income | Net (Loss) Income | Diluted EPS | | :--- | :--- | :--- | :--- | :--- | :--- | | **2020** | $248,234 | $208,904 | $(45,398) | $(49,284) | $(0.77) | | **2019** | $299,255 | $256,174 | $(21,160) | $(25,580) | $(0.24) | | **2018** | $359,111 | $322,725 | $(3,924) | $(29,979) | $(0.28) | | **2017** | $321,139 | $285,920 | $46,223 | $64,727 | $0.56 | | **2016** | $221,712 | $190,774 | $884 | $390 | $0.00 | Selected Balance Sheet Data (in thousands) | As of Dec 31 | Total Assets | Total Liabilities | Total Stockholders' (Deficit) Equity | | :--- | :--- | :--- | :--- | | **2020** | $202,032 | $110,614 | $(150) | | **2019** | $167,166 | $132,768 | $34,398 | | **2018** | $122,844 | $73,189 | $49,655 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=72&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses a 17.0% decrease in 2020 net sales due to revenue recognition changes and COVID-19, a $49.3 million net loss, significant legal expenses, and improved liquidity from recent financing Results of Operations Comparison (2020 vs. 2019, in thousands) | Metric | 2020 | 2019 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | **Net Sales** | $248,234 | $299,255 | $(51,021) | (17.0)% | | **Gross Profit** | $208,904 | $256,174 | $(47,270) | (18.5)% | | **Operating Loss** | $(45,398) | $(21,160) | $(24,238) | 114.5% | | **Net Loss** | $(49,284) | $(25,580) | $(23,704) | 92.7% | - The decrease in 2020 net sales was primarily due to a change in revenue recognition policy and the impacts of the COVID-19 pandemic, which restricted facility access and reduced elective procedures[379](index=379&type=chunk) - The company changed its revenue recognition pattern effective October 1, 2019, moving from recognizing revenue upon cash receipt (due to control environment weaknesses) to recognizing it upon shipment or implantation for new contracts[333](index=333&type=chunk)[343](index=343&type=chunk) - In July 2020, the company completed major financing transactions, including a **$50 million** term loan and a **$100 million** issuance of Series B Preferred Stock, which significantly improved its liquidity and was used to refinance existing debt[309](index=309&type=chunk)[320](index=320&type=chunk) - Investigation, restatement, and related expenses were significant, totaling **$59.5 million** in 2020 and **$66.5 million** in 2019, primarily for legal fees and indemnification costs for former management[384](index=384&type=chunk) - The company expects adjusted net sales to increase by at least **10%** in 2021, contingent on the ability to continue selling its micronized, particulate, and umbilical cord products for the full year[381](index=381&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=98&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company reported no material market risk exposure as of December 31, 2020, due to the absence of market risk sensitive instruments - The company determined it had no material market risk exposure as of December 31, 2020[447](index=447&type=chunk) [Financial Statements and Supplementary Data](index=99&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents audited consolidated financial statements for 2018-2020, with the auditor issuing an unqualified opinion on financials but an adverse opinion on internal control over financial reporting - The independent auditor, BDO USA, LLP, issued an unqualified opinion on the consolidated financial statements[451](index=451&type=chunk) - The independent auditor issued an adverse opinion on the effectiveness of the company's internal control over financial reporting as of December 31, 2020, citing identified material weaknesses[452](index=452&type=chunk)[462](index=462&type=chunk) Key Financial Statement Data (as of Dec 31, 2020, in thousands) | Metric | Amount | | :--- | :--- | | **Assets** | | | Cash and cash equivalents | $95,812 | | Total Assets | $202,032 | | **Liabilities & Equity** | | | Total Liabilities | $110,614 | | Convertible preferred stock | $91,568 | | Total Stockholders' (Deficit) | $(150) | [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=153&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reported no changes in or disagreements with its accountants regarding accounting principles, financial disclosure, or auditing scope - The company reported no disagreements with its accountants on accounting and financial disclosure[690](index=690&type=chunk) [Controls and Procedures](index=153&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were ineffective as of December 31, 2020, due to ongoing material weaknesses in internal control over financial reporting, particularly in Control Activities - Management concluded that disclosure controls and procedures were not effective as of December 31, 2020, due to material weaknesses in internal control over financial reporting[692](index=692&type=chunk)[695](index=695&type=chunk) - Material weaknesses were identified in the Control Activities component of the COSO framework, affecting processes such as revenue recognition, inventory, income taxes, segregation of duties, and financial forecasting[698](index=698&type=chunk)[699](index=699&type=chunk) - The company has remediated the previously disclosed material weaknesses related to the Control Environment by restructuring the board, enhancing compliance training, and improving accountability[701](index=701&type=chunk) - Remediation plans for the remaining material weaknesses are underway, including enhancing the financial close process, improving controls over income tax accounting, and strengthening oversight of sales activities[700](index=700&type=chunk)[710](index=710&type=chunk)[711](index=711&type=chunk) [Other Information](index=158&type=section&id=Item%209B.%20Other%20Information) The Board of Directors appointed a new Class II director and adopted restated articles of incorporation in early March 2021 - Dr. Phyllis Gardner was appointed to the Board of Directors, effective immediately following the filing of this annual report[721](index=721&type=chunk) - The company adopted restated articles of incorporation, effective March 5, 2021[725](index=725&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=159&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information on directors, executive officers, and corporate governance is incorporated by reference from the 2021 proxy statement - Information regarding directors, executive officers, and corporate governance will be provided in the forthcoming 2021 proxy statement[728](index=728&type=chunk) [Executive Compensation](index=159&type=section&id=Item%2011.%20Executive%20Compensation) Details on executive compensation are incorporated by reference from the 2021 proxy statement - Details on executive compensation will be provided in the forthcoming 2021 proxy statement[729](index=729&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=159&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information on security ownership and related stockholder matters is incorporated by reference from the 2021 proxy statement - Information on security ownership and related matters will be provided in the forthcoming 2021 proxy statement[730](index=730&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=159&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Details on certain relationships, related transactions, and director independence are incorporated by reference from the 2021 proxy statement - Details on certain relationships, related transactions, and director independence will be provided in the forthcoming 2021 proxy statement[731](index=731&type=chunk) [Principal Accounting Fees and Services](index=159&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information on principal accounting fees and services is incorporated by reference from the 2021 proxy statement - Information on principal accounting fees and services will be provided in the forthcoming 2021 proxy statement[732](index=732&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=160&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists all financial statement schedules and exhibits filed with the Form 10-K, including corporate governance documents, material contracts, and required certifications - This section contains a comprehensive list of all exhibits filed with the Form 10-K, including corporate governance documents, material contracts, and required certifications[735](index=735&type=chunk)[736](index=736&type=chunk) [Form 10-K Summary](index=165&type=section&id=Item%2016.%20Form%2010-K%20Summary) A Form 10-K summary is not provided as it is not applicable - A Form 10-K summary is not provided as it is not applicable[742](index=742&type=chunk)

| --- | --- | --- | |-------------------------------------------------------------------------------|-------|-------| | | | | | INNOVATING TREATMENTS THROUGH ADVANCED PLACENTAL SCIENCE January 11-14, 2021 | | | | 2021 J.P. Morgan 39th Annual Healthcare Conference | | | IMPORTANT CAUTIONARY STATEMENT This presentation contains forward-looking statements. Investors are cautioned against placing undue reliance on these statements. All statements relating to events or results that may occur in the future are fo ...

Financial Data and Key Metrics Changes - Net sales for Q3 2020 were $64.3 million, a decrease of 27.7% from $88.9 million in Q3 2019, but a sequential increase of 22% from Q2 2020 [44][45][46] - Adjusted net sales for Q3 2020 were $63.3 million, down 6.2% from the same period in 2019 [45] - Gross margin for Q3 2020 was 84.0%, compared to 85.1% in Q3 2019 [50] - Net loss for Q3 2020 was $19.4 million, compared to a net income of $12.4 million in Q3 2019 [57][58] - Adjusted EBITDA was $6.9 million in Q3 2020, or 10.8% of net sales, compared to $7.6 million or 8.5% of net sales in Q3 2019 [59] Business Line Data and Key Metrics Changes - The company reported a strong rebound in sequential sales growth, with a 22% increase over the prior quarter [11] - Research and Development expenses increased to $3.4 million in Q3 2020 from $2.7 million in Q3 2019, driven by clinical research efforts [55] Market Data and Key Metrics Changes - The company is positioned to benefit from new payer coverage for its flagship product EpiFix, which will begin on December 1, 2020 [17][19] - The coverage is expected to provide a competitive advantage in the diabetic foot ulcer market [19] Company Strategy and Development Direction - The company aims to enhance portfolio value by highlighting clinical and economic benefits and expanding into new applications [28] - Plans for international expansion are being pursued in a controlled manner [29] - The company is focused on operationalizing its strategy and leveraging recent wins, particularly with payer coverage and new product innovations [41][96] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the recovery from the pandemic but remains cautious due to ongoing uncertainties [47][49] - The company is committed to maintaining high-quality standards and operational efficiencies [60] Other Important Information - The company had approximately $109.6 million in cash and cash equivalents as of September 30, 2020, compared to $69.1 million at the end of 2019 [61][62] - The company is actively engaging with investors and analysts following its NASDAQ listing [63] Q&A Session Summary Question: Market potential for AmnioFix in Knee OA - Management acknowledged the potential of AmnioFix as a treatment for Knee OA and emphasized the importance of demonstrating clinical efficacy and safety in ongoing trials [66][67][70] Question: Details on contract wins - Management confirmed successful contract wins but did not disclose specific details at this time, highlighting the significance of coverage from a major U.S. commercial payer [72] Question: Expansion of salesforce - Management indicated the need to increase the salesforce but did not provide specific numbers, emphasizing the importance of having the right people in the right places [76][78] Question: Investigation expenses - Management clarified that investigation expenses are variable and related to indemnification agreements with former management, with no cap on those expenses [81] Question: Coverage and additional wins - Management discussed the importance of expanding covered lives and indications, emphasizing the validation of clinical data [84][85]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________________to______________________ Commission File Number 001-35887 MIMEDX GROUP, INC. (Exact name of registrant as specified in its charter) Florida 26-2 ...

MiMedx Group, Inc. (NASDAQ:MDXG) Q2 2020 Earnings Conference Call August 11, 2020 8:30 AM ET Company Participants Hilary Dixon - VP of IR and Corporate Communications Tim Wright - CEO Pete Carlson - CFO Conference Call Participants Eiad Asbahi - Prescience Point Capital Management Brian Finn - FIN Capital Operator Good morning and welcome to the MiMedx Second Quarter 2020 Financial Results Conference Call. All participants will be in a listen-only mode. [Operator Instructions] After today's presentation, th ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________________to______________________ Commission File Number 001-35887 MIMEDX GROUP, INC. | | | Name of each exchange on which | | --- | --- | --- | | Title of ea ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________________to______________________ Commission file number 001-35887 MIMEDX GROUP, INC. (Exact name of registrant as specified in its charter) (State or ot ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________________to______________________ Commission file number 001-35887 MIMEDX GROUP, INC. (Exact name of registrant as specified in its charter) Florida 26-279255 ...