MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”), today announced operating and financial results for the third quarter 2024.

Joseph H. Capper, MIMEDX Chief Executive Officer, commented, "Our solid third quarter 2024 results include total net sales growth of 3% year-over-year and an Adjusted EBITDA margin of 22%, both compared to tough comparisons in the third quarter of 2023. During the quarter, we strengthened our commercial organization, filling roles throughout the country, and continued to execute on our strategic priorities, which I believe will put us in the best position to lead this space over the long term. This performance, along with the associated free cash flow generation, demonstrates the strength of our Company even as we weather reimbursement-related market disruption. As a result, we now expect our 2024 net sales growth will be on the upper end of our prior stated guidance range of mid-to-high single-digits."

Mr. Capper continued, "During the quarter, we continued conversations with CMS, lawmakers and the MACs, leaving us optimistic that change is coming to address the runaway Medicare spend in the private office and associated care settings, which is now over $1 billion per month.   As we have known for some time, and The New York Times recently pointed out, the potential for placental tissue products is enormous. Our unwavering commitment to research and evidence production designed to support expanded utilization of our products puts us in an advantageous position as more clinicians seek to incorporate placental allografts into their practices."

       
  Three Months EndedSeptember 30,   Nine Months EndedSeptember 30,
    2024       2023       2024       2023  
Net Income $ 8,095     $ 8,534     $ 34,981     $ 4,751  
Non-GAAP Adjustments:              
Depreciation expense   580       653       1,715       2,054  
Amortization of intangible assets   575       190       1,336       570  
Interest (income) expense, net   (278 )     1,680       1,409       4,864  
Income tax provision   3,541       591       11,485       569  
Share-based compensation   3,810       4,389       12,240       12,793  
Investigation, restatement and related expenses   649       (38 )     (8,741 )     4,652  
Impairment of intangible assets   298             352        
Transaction related expenses   95             651        
Strategic legal and regulatory expenses   1,035             1,666        
Expenses related to disbanding of Regenerative Medicine Business Unit   (217 )     208       (421 )     5,599  
Reorganization expenses         1,412             1,412  
Adjusted EBITDA $ 18,183     $ 17,619     $ 56,673     $ 37,264  
Adjusted EBITDA margin   21.6 %     21.6 %     22.1 %     15.9 %
                               
                               

Third Quarter 2024 Results Discussion1

Net Sales

MIMEDX reported net sales for the three months ended September 30, 2024, of $84 million, compared to $82 million for the three months ended September 30, 2023, an increase of 3%. The increase was primarily driven by growing contributions from its AMNIOEFFECT® and EPIEFFECT® products and initial contributions associated with sales of our recently launched HELIOGEN® product, partially offset by commercial challenges associated with recent turnover of certain of our sales team and customers, declines in sales of AXIOFILL® and the conclusion of sales of our dental product during the third quarter 2023.

Gross Profit and Margin

Gross profit for the three months ended September 30, 2024, was $69 million, an increase of $2 million as compared to the prior year period. Gross margin for the three months ended September 30, 2024 was 81.8%, compared to 81.9% in the prior year period. While third quarter 2024 gross margin was negatively impacted by the amortization of distribution rights stemming from the TELA Bio, Inc. and Regenity Biosciences agreements entered into during the first quarter of 2024, this impact was offset by favorable product mix and continued execution on improvements in manufacturing scale up, including reductions in scrap and improvements in yield.

Operating Expenses

Selling, general and administrative ("SG&A") expenses for the three months ended September 30, 2024, were $54 million compared to $53 million for the three months ended September 30, 2023. The increase in SG&A was driven by year-over-year increases in compensation related to higher salary and benefit costs from merit raises, promotions, as well as commissions driven by increases in sales volumes and proportionally higher sales through sales agents. Incremental spend from legal and regulatory disputes in the current period also contributed to the increase.

Research and development ("R&D") expenses for the three months ended September 30, 2024, were $3 million compared to $3 million for the three months ended September 30, 2023. R&D spend in the quarter was driven, in part, by the randomized controlled trial for EPIEFFECT and ongoing investments in the development of future products in our pipeline.

Investigation, restatement and related expense for the three months ended September 30, 2024, was $1 million compared to an immaterial benefit for the three months ended September 30, 2023. The benefit in the third quarter 2023 resulted from various settlements, including those with former officers and other matters.

Net income from continuing operations for the three months ended September 30, 2024 was $8 million compared to $9 million for the three months ended September 30, 2023.

Cash and Cash Equivalents

As of September 30, 2024, the Company had $89 million of cash and cash equivalents compared to $82 million as of December 31, 2023. As of September 30, 2024, our cash position, net of debt on our balance sheet, was $70 million, representing a sequential increase of $20 million.

Financial OutlookFor 2024, MIMEDX expects net sales growth to be in the high single-digits as a percentage compared to 2023. 2024 Adjusted EBITDA margin is expected to be above 20% on a full year basis.

Longer-term, the Company continues to expect to achieve annual net sales growth in the low double-digits as a percentage with an adjusted EBITDA margin above 20%.

Conference Call and Webcast

MIMEDX will host a conference call and webcast to review its second quarter 2024 results on Wednesday, October 30, 2024, beginning at 4:30 p.m., Eastern Time. The call can be accessed using the following information:

Webcast: Click here U.S. Investors: 877-407-6184International Investors: 201-389-0877Conference ID: 13748866

A replay of the webcast will be available for approximately 30 days on the Company’s website at www.mimedx.com following the conclusion of the event.

Important Cautionary Statement

This press release includes forward-looking statements. Statements regarding: (i) future sales or sales growth; (ii) our 2024 and longer term financial goals and expectations for future financial results, including levels of net sales, Adjusted EBITDA, and Adjusted EBITDA margin; (iii) our expectations regarding the placental tissue market (iv) our expectations regarding Medicare spending;   and (v) continued growth in different care settings, including regarding placental allografts. Additional forward-looking statements may be identified by words such as "believe," "expect," "may," "plan," “goal,” “outlook,” "potential," "will," "preliminary," and similar expressions, and are based on management's current beliefs and expectations.

Forward-looking statements are subject to risks and uncertainties, and the Company cautions investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Factors that could cause actual results to differ from expectations include: (i) future sales are uncertain and are affected by competition, access to customers, patient access to healthcare providers, the reimbursement environment and many other factors; (ii) the Company may change its plans due to unforeseen circumstances; (iii) the results of scientific research are uncertain and may have little or no value; (iv) our ability to sell our products in other countries depends on a number of factors including adequate levels of reimbursement, market acceptance of novel therapies, and our ability to build and manage a direct sales force or third party distribution relationship; (v) the effectiveness of amniotic tissue as a therapy for particular indications or conditions is the subject of further scientific and clinical studies; (vi) we may alter the timing and amount of planned expenditures for research and development based on regulatory developments; (vii) Medicare spending; and (viii) changes in the size of the addressable market for our products. The Company describes additional risks and uncertainties in the Risk Factors section of its most recent annual report and quarterly reports filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and the Company assumes no obligation to update any forward-looking statement.

About MIMEDX

MIMEDX is a pioneer and leader focused on helping humans heal. With more than a decade of helping clinicians manage chronic and other hard-to-heal wounds, MIMEDX is dedicated to providing a leading portfolio of products for applications in the wound care, burn, and surgical sectors of healthcare. The Company’s vision is to be the leading global provider of healing solutions through relentless innovation to restore quality of life. For additional information, please visit www.mimedx.com.

Contact:Matt NotarianniInvestor Relations470.304.7291mnotarianni@mimedx.com

Selected Unaudited Financial Information

 
MiMedx Group, Inc.
Condensed Consolidated Balance Sheets
(in thousands) Unaudited
  September 30,2024   December 31,2023
ASSETS      
Current assets:      
Cash and cash equivalents $ 88,801   $ 82,000
Accounts receivable, net   54,030     53,871
Inventory   24,249     21,021
Prepaid expenses   2,907     5,624
Other current assets   2,152     1,745
Total current assets   172,139     164,261
       
Property and equipment, net   6,451     6,974
Right of use asset   2,843     2,132
Deferred tax asset, net   30,636     40,777
Goodwill   19,441     19,441
Intangible assets, net   11,201     5,257
Other assets   1,180     205
Total assets $ 243,891   $ 239,047
LIABILITIES AND STOCKHOLDERS’ EQUITY      
Current liabilities:      
Current portion of long term debt $ 1,000   $ 1,000
Accounts payable   6,924     9,048
Accrued compensation   20,170     22,353
Accrued expenses   8,396     9,361
Current portion of Profit Share Payments   2,860    
Current liabilities of discontinued operations       1,352
Other current liabilities   2,591     2,894
Total current liabilities   41,941     46,008
Long term debt, net   18,018     48,099
Other liabilities   2,924     2,223
Total liabilities $ 62,883   $ 96,330
Total stockholders' equity   181,008     142,717
Total liabilities and stockholders’ equity $ 243,891   $ 239,047
           
           

 
MiMedx Group, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts) Unaudited
  Three Months EndedSeptember 30,   Nine Months EndedSeptember 30,
    2024       2023       2024       2023  
               
Net sales $ 84,057     $ 81,712     $ 255,972     $ 234,645  
Cost of sales   15,322       14,790       43,164       40,792  
Gross profit   68,735       66,922       212,808       193,853  
               
Operating expenses:              
Selling, general and administrative   53,516       52,571       164,044       156,773  
Research and development   2,918       3,075       8,770       10,232  
Investigation, restatement and related   649       (38 )     (8,741 )     4,652  
Amortization of intangible assets   192       190       572       570  
Impairment of intangible assets   298             352        
Operating income   11,162       11,124       47,811       21,626  
               
Other expense, net              
Interest income (expense), net   278       (1,680 )     (1,409 )     (4,864 )
Other expense, net   (21 )     (11 )     (357 )     (42 )
Income from continuing operations before income tax provision   11,419       9,433       46,045       16,720  
Income tax provision   (3,541 )     (591 )     (11,485 )     (569 )
Net income from continuing operations   7,878       8,842       34,560       16,151  
Income (loss) from discontinued operations, net of tax   217       (308 )     421       (11,400 )
Net income $ 8,095     $ 8,534     $ 34,981     $ 4,751  
               
Net income available to common stockholders from continuing operations $ 7,878     $ 7,069     $ 34,560     $ 10,967  
               
Basic net income per common share:              
Continuing operations   0.05       0.06       0.24       0.09  
Discontinued operations                     (0.09 )
Basic net income per common share $ 0.05     $ 0.06     $ 0.24     $  
               
Diluted net income per common share:              
Continuing operations $ 0.05     $ 0.06     0.23     0.09  
Discontinued operations                     (0.09 )
Diluted net income per common share $ 0.05     $ 0.06     $ 0.23     $  
               
Weighted average common shares outstanding - basic   146,958,986       116,298,146       147,008,732       115,528,067  
Weighted average common shares outstanding - diluted   148,373,631       149,773,706       148,964,788       116,893,270  
                               
                               

 
MiMedx Group, Inc.
Condensed Consolidated Statements of Cash Flows
(in thousands) Unaudited
  Nine Months EndedSeptember 30,
    2024       2023  
Net cash flows provided by operating activities from continuing operations $ 48,347     $ 25,667  
Net cash flows used in operating activities of discontinued operations   (931 )     (9,149 )
Net cash flows provided by operating activities $ 47,416     $ 16,518  
Net cash flows used in investing activities   (6,816 )     (1,674 )
Net cash flows used in financing activities   (33,799 )     370  
Net change in cash $ 6,801     $ 15,214  
               
               

Reconciliation of Non-GAAP Measures

In addition to our GAAP results, we provide certain non-GAAP measures including Adjusted EBITDA, related margins, Free Cash Flow, Adjusted Gross Profit, Adjusted Gross Margin, Adjusted Net Income, and Adjusted Earnings Per Share ("Adjusted EPS"). We believe that the presentation of these measures provides important supplemental information to management and investors regarding our performance. These measures are not a substitute for GAAP measures. Company management uses these non-GAAP measures as aids in monitoring our ongoing financial performance from quarter-to-quarter and year-to-year on a regular basis and for benchmarking against comparable companies.

These non-GAAP financial measures reflect the exclusion of the following items:

  • Share-based compensation expense - expense recognized related to awards to employees and our board of directors pursuant to our share-based compensation plans. This expense is reflected amongst cost of sales, research and development expense, and selling, general, and administrative expense in the unaudited condensed consolidated statements of operations.
  • Investigation, restatement, and related (benefit) expense - expenses incurred toward the legal defense of the Company and advanced on behalf of certain former officers and directors, net of negotiated reductions and settlements of amounts previously advanced, related to certain legal matters. This expense is reflected in the line of the same name in our unaudited condensed consolidated statements of operations.
  • Impairment of intangible assets - reflects the impairment of intangibles. This expense is reflected in the line of the same name in our unaudited condensed consolidated statements of operations.
  • Transaction-related expenses - reflects expenses incrementally incurred resulting from the consummation of material strategic transactions or the integration of acquired assets or operations into our core business. With respect to the three and nine months ended September 30, 2024, this relates to our acquisition and integration of exclusive distribution rights to HELIOGEN.
  • Strategic legal and regulatory expenses - With respect to the three and nine months ended September 30, 2024, this relates to litigation and regulatory expenses. Litigation expenses incurred relate to suits filed against former employees and their employers for violation of non-compete and non-solicitation agreements and related matters. Regulatory expenses relate to legal fees incurred stemming from action taken against the United States Food & Drug Administration ("FDA") surrounding the designation of one of our products.
  • Loss on extinguishment of debt - reflects the excess of cash paid to extinguish debt over the carrying value of the debt on our balance sheet upon the repayment and termination of a loan agreement. With respect to the nine months ended September 30, 2024, this relates to the repayment and termination of the Company's loan agreement with Hayfin. Amounts in this line reflect (i) prepayment premium paid and (ii) write-offs of unamortized original issue discount and deferred financing costs.
  • Expenses related to the Disbanding of Regenerative Medicine - incremental expenses recognized or incurred directly as a result of our announcement to disband our Regenerative Medicine segment.
  • Amortization of acquired intangible assets - reflects amortization expense recognized solely related to assets which were acquired as part of a transaction. With respect to the three and nine months ended September 30, 2024, this relates solely to the amortization of distribution rights stemming from the TELA Bio, Inc. and Regenity Biosciences agreements entered into during the first quarter of 2024. These expenses are reflected in cost of sales in our consolidated statements of operations.
  • Reorganization expenses - reflects severance expense incurred arising from separations from certain officers of the Company.
  • Income Tax Adjustment - for purposes of calculating Adjusted Net Income and Adjusted Earnings Per Share, reflects our expectation of a long-term effective tax rate, which is normalized and balance sheet-agnostic. Actual reporting tax expense will be based on GAAP earnings, and may differ from the expected long-term effective tax rate due to a variety of factors, including the tax treatment of various transactions included in GAAP net income and other reconciling items that are excluded in determining Adjusted Net Income and Adjusted EPS. The actual long-term normalized effective tax rate was 25% for each of the quarters ended September 30, 2024 and 2023.

Adjusted EBITDA and Adjusted EBITDA margin

Adjusted EBITDA consists of GAAP net income excluding: (i) depreciation, (ii) amortization of intangibles, (iii) interest (income) expense, net, (iv) income tax provision, (v) share-based compensation, (vi) investigation, restatement and related expenses, (vii) expenses related to disbanding of the Regenerative Medicine business unit, (viii) strategic legal and regulatory expenses, (ix) transaction-related expenses, (x) impairment of intangible assets, and (xi) reorganization expenses.

Please refer to the tables at the beginning of this press release for reconciliation to GAAP net income (loss).

Adjusted Net Income

Adjusted Net Income provides a view of our operating performance, exclusive of certain items which are non-recurring or not reflective of our core operations.

Adjusted Net Income is defined as GAAP net income plus (i) loss on extinguishment of debt, (ii) investigation restatement and related expenses, (iii) impairment of intangible assets, (iv) amortization of acquired intangible assets, (v) transaction related expenses, (vi) strategic legal and regulatory expenses, and (vii) expenses related to disbanding of our Regenerative Medicine business unit, and (viii) the long-term effective income tax rate adjustment.

A reconciliation of GAAP net income to Adjusted Net Income appears in the table below (in thousands):

       
  Three Months EndedSeptember 30,   Nine Months EndedSeptember 30,
    2024       2023       2024       2023  
Net income $ 8,095     $ 8,534     $ 34,981     $ 4,751  
Loss on extinguishment of debt               1,401        
Investigation, restatement and related expenses   649       (38 )     (8,741 )     4,652  
Impairment of intangible assets   298             352        
Amortization of acquired intangible assets   383             765        
Transaction related expenses   95             651        
Strategic legal and regulatory expenses   1,035             1,666        
Expenses related to disbanding of Regenerative Medicine Business Unit   (217 )     208       (421 )     5,599  
Reorganization expenses         1,412             1,412  
Long-term effective income tax rate adjustment   71       (2,086 )     950       (3,677 )
Adjusted net income $ 10,409     $ 8,030     $ 31,604     $ 12,737  
                               
                               

A reconciliation of various line items included in our GAAP unaudited condensed consolidated statements of operations to Adjusted Net Income for the three and nine months ended September 30, 2024 and 2023 are presented in the tables below (in thousands):

   
  Three Months Ended September 30, 2024
  Gross Profit   Selling, General & Administrative Expense   Research and Development Expense   Net Income
Reported GAAP Measure $ 68,735     $ 53,516     $ 2,918   $ 8,095  
Investigation, restatement and related expenses                   649  
Impairment of intangible assets                   298  
Amortization of acquired intangible assets   383                 383  
Transaction-related expenses         (36 )         95  
Strategic legal and regulatory expenses         (1,035 )         1,035  
Expenses related to disbanding of Regenerative Medicine Business Unit                   (217 )
Long-term effective income tax rate adjustment                   71  
Non-GAAP Measure $ 69,118     $ 52,445     $ 2,918   $ 10,409  
               
Gross Profit Margin   81.8 %            
Gross Profit Margin, as adjusted   82.2 %            
                   

  Three months ended September 30, 2023
  Gross Profit   Selling, General & Administrative Expense   Research and Development Expense   Net Income
Reported GAAP Measure $         66,922             $         52,571             $         3,075           $         8,534          
Investigation, restatement and related expenses           —                       —                       —                     (38 )
Expenses related to disbanding of Regenerative Medicine Business Unit           —                       —                       —                     208          
Reorganization expenses           —                       (1,412 )             —                     1,412          
Long-term effective income tax rate adjustment           —                       —                       —                     (2,086 )
Non-GAAP Measure $         66,922             $         51,159             $         3,075           $         8,030          
               
Gross Profit Margin           81.9         %            
Gross Profit Margin, as adjusted           81.9         %            
                   

  Nine Months Ended September 30, 2024
  Gross Profit   Selling, General & Administrative Expense   Research and Development Expense   Net Income
Reported GAAP Measure $ 212,808     $ 164,044     $ 8,770   $ 34,981  
Loss on extinguishment of debt                   1,401  
Investigation, restatement and related expenses                   (8,741 )
Impairment of intangible assets                   352  
Amortization of acquired intangible assets   765                 765  
Transaction related expenses         (522 )         651  
Strategic legal and regulatory expenses         (1,666 )         1,666  
Expenses related to disbanding of Regenerative Medicine Business Unit                   (421 )
Long-term effective income tax rate adjustment                   950  
Non-GAAP Measure $ 213,573     $ 161,856     $ 8,770   $ 31,604  
               
Gross Profit Margin   83.1 %            
Gross Profit Margin, as adjusted   83.4 %            
                   

  Nine Months Ended September 30, 2023
  Gross Profit   Selling, General & Administrative Expense   Research and Development Expense   Net Income
Reported GAAP Measure $ 193,853     $ 156,773     $ 10,232   4,751  
Investigation, restatement and related expenses                   4,652  
Expenses related to disbanding of Regenerative Medicine Business Unit                   5,599  
Reorganization expenses         (1,412 )         1,412  
Long-term effective income tax rate adjustment                   (3,677 )
Non-GAAP Measure $ 193,853     $ 155,361     $ 10,232   $ 12,737  
               
Gross Profit Margin   82.6 %            
Gross Profit Margin, as adjusted   82.6 %            
                   
                   

Adjusted Earnings Per Share

Adjusted Earnings Per Share is intended to provide a normalized view of earnings per share by removing items that may be irregular, one-time, or non-recurring from net income. This enables us to identify underlying trends in our business that could otherwise be masked by such items. Adjusted Earnings Per Share consists of GAAP diluted net income (loss) per common share including adjustments for: (i) loss on extinguishment of debt, (ii) investigation restatement and related expenses, (iii) impairment of intangible assets, (iv) amortization of acquired intangible assets, (v) transaction related expenses, (vi) strategic legal and regulatory expenses, (vii) expenses related to disbanding of our Regenerative Medicine business unit, (viii) reorganization expenses, (ix) the long-term effective income tax rate adjustment, and (x) the effect of antidilution. The effect of antidilution reflects the changes resulting from the removal of the dilutive impact of convertible securities which were dilutive for purposes of calculating GAAP net income per common share, but are antidilutive for non-GAAP purposes.

A reconciliation of GAAP diluted earnings per share to Adjusted Earnings Per Share appears in the table below (per diluted share):

       
  Three Months EndedSeptember 30,   Nine Months EndedSeptember 30,
    2024     2023       2024       2023  
GAAP net income per common share - diluted $ 0.05   $ 0.06     $ 0.23     $ 0.00  
Loss on extinguishment of debt   0.00     0.00       0.01       0.00  
Investigation, restatement and related (benefit) expense   0.01     0.00       (0.06 )     0.04  
Impairment of intangible assets   0.00     0.00       0.00       0.00  
Amortization of acquired intangible assets   0.00     0.00       0.01       0.00  
Transaction related expenses   0.00     0.00       0.00       0.00  
Strategic legal and regulatory expenses   0.01     0.00       0.01       0.00  
Expenses related to disbanding of Regenerative Medicine business unit   0.00     0.01       0.00       0.04  
Reorganization expenses   0.00     0.01       0.00       0.01  
Long-term effective income tax rate adjustment   0.00     (0.02 )     0.01       (0.03 )
Effects of antidilution   0.00     (0.01 )     0.00       0.00  
Adjusted Earnings Per Share $ 0.07   $ 0.05     $ 0.21     $ 0.06  
               
GAAP weighted average common shares outstanding - diluted   148,373,631     149,773,706       148,964,788       116,893,270  
Effects of antidilution       (30,445,997 )            
Weighted average common shares outstanding - adjusted   148,373,631     119,327,709       148,964,788       116,893,270  
                             
                             

Free Cash Flow

Free Cash Flow is intended to provide a measure of our ability to generate cash in excess of capital investments. It provides management with a view of cash flows which can be used to finance operational and strategic investments.

Free Cash Flow is defined as net cash provided by operating activities less capital expenditures, including purchases of equipment.

A reconciliation of GAAP net cash flows provided by operating activities to Free Cash Flow appears in the table below (in thousands):

       
  Three Months EndedSeptember 30,   Nine Months EndedSeptember 30,
    2024       2023       2024       2023  
Net cash flows provided by operating activities $ 19,624     $ 12,791     47,416     16,518  
Capital expenditures, including purchases of equipment   (171 )     (628 )     (1,420 )     (1,560 )
Free Cash Flow $ 19,453     $ 12,163     $ 45,996     $ 14,958  
                               
                               

Net Sales by Product Category by Quarter

Below is a summary of net sales by product category (in thousands):

       
  2023   2024
  Q1   Q2   Q3   Q4   Q1   Q2   Q3
Wound $ 45,206   $ 53,318   $ 51,156   $ 55,980   $ 57,049   $ 57,547   $ 55,052
Surgical   26,470     27,939     30,556     30,852     27,660     29,660     29,005
Net sales $ 71,676   $ 81,257   $ 81,712   $ 86,832   $ 84,709   $ 87,207   $ 84,057
                                         

 

 

________________________1 The following discussion of the Company's third quarter 2024 results are made on a "continuing operations basis" and exclude the historical costs of the Regenerative Medicine business unit, which was disbanded beginning in June 2023. For a full discussion of the impact of these discontinued operations, please refer to our Annual Report on Form 10-K filed with the Securities and Exchange Commission for the year ended December 31, 2023 and our Quarterly Report on Form 10-Q for the three months ended September 30, 2024.

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