MIMEDX has three main sites of service for its products (1) Hospital settings and wound care clinics, which are stable reimbursement settings in which products are used for both wound and surgical applications, (2) Private offices, which generally represents doctors and practitioners with independent operations treating wound patients, and (3) Other, which includes federal facilities, international sales, and other sites of service using products for both wound and surgical applications.
Below is a summary of net sales by site of service (in thousands):
Three Months Ended September 30,
Nine Months Ended September 30,
2024
2023
2024
2023
Hospital
$
46,034
$
47,350
$
137,174
$
136,108
Private Office
25,585
22,951
82,874
68,188
Other
12,438
11,411
35,924
30,349
Total
$
84,057
$
81,712
$
255,972
234,645
19
Net Sales by Product Category
MIMEDX has two product categories: (1) Wound, which reflects products typically used in Advanced Wound Care settings, including the treatment of chronic, non-healing wounds, and (2) Surgical, which reflects products principally used in surgical settings, including the closure of acute wounds or to protect and reinforce tissues and/or regions of interest. The Company manages its product portfolio and pipeline based upon opportunities in each of these settings.
Below is a summary of net sales by product line (in thousands):
Three Months Ended September 30,
Nine Months Ended September 30,
2024
2023
2024
2023
Wound
$
55,052
$
51,156
$
169,647
$
149,681
Surgical
29,005
30,556
86,325
84,964
Total
$
84,057
$
81,712
$
255,972
$
234,645
The Company did not have significant foreign operations or a single external customer from which 10% or more of revenues were derived during the three or nine months ended September 30, 2024 or 2023.
14. Discontinued Operations
Disbanding of Regenerative Medicine Business Unit
In the second quarter of 2023, the Company announced the disbanding of its Regenerative Medicine reportable segment and the suspension of its Knee Osteoarthritis clinical trial program. The announcement reflected the abandonment of the Company’s efforts to pursue a Biological License Application for its micronized dehydrated human amnion chorion membrane product and a major definitive strategic shift in the Company’s focus towards its continuing commercial pipeline as its primary source of value creation.
The Company completed the regulatory obligations associated with the clinical trial during the fourth quarter of 2023, at which time material run-off operations had ceased and Regenerative Medicine met the criteria for presentation as a discontinued operation.
Financial Statement Impact of Discontinued Operations
The income and expenses of the discontinued operation have been classified as income (loss) from discontinued operations in the consolidated statements of operations for the three and nine months ended September 30, 2024 and 2023 as follows (in thousands):
Three Months Ended September 30,
Nine Months Ended September 30,
2024
2023
2024
2023
Selling, general and administrative expense
$
(217)
$
—
$
(221)
$
—
Research and development expense
—
100
(200)
7,937
Restructuring expense
—
208
—
3,463
Income (loss) from discontinued operations
$
217
$
(308)
$
421
$
(11,400)
20
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Overview
Executive Summary
During the third quarter of 2024, the Company delivered 2.9% growth in net sales year-over-year. Growth in the third quarter was seen in private office sites and was relatively balanced between Wound & Surgical products. In particular, the Company saw growth of its EPIEFFECT® and AMNIOEFFECT® 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.
Operational and financial highlights during the quarter included:
•Net sales of $84.1 million, reflecting 2.9% growth over the prior year period.
•GAAP net income from continuing operations and net income margin for the third quarter of 2024 of $7.9 million and 9.4%, respectively.
•Showcased leading allograft portfolio and latest scientific and clinical evidence at Symposium on Advanced Wound Care (SAWC) Fall.
•Highlighted the publication of a feature article on placental allografts for patients with hard-to-heal, acute and chronic wounds in The New York Times.
Overview
MIMEDX is a pioneer and leader focused on helping humans heal. With more than a decade of experience helping clinicians manage acute and chronic wounds, MIMEDX has been dedicated to providing 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 U.S. Food & Drug Administration (“FDA”). We apply Current Good Tissue Practices (“CGTP”) and other applicable quality standards in addition to terminal sterilization to produce our allografts.
This discussion, which presents our results for the three and nine months ended September 30, 2024 and 2023, should be read in conjunction with the 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, 2023.
21
Results of Operations
Three Months Ended September 30, 2024 Compared to the Three Months Ended September 30, 2023
Three Months Ended September 30,
(in thousands)
2024
2023
$ Change
% Change
Net sales
$
84,057
$
81,712
$
2,345
2.9
%
Cost of sales
15,322
14,790
532
3.6
%
Gross profit
68,735
66,922
1,813
2.7
%
Selling, general and administrative
53,516
52,571
945
1.8
%
Research and development
2,918
3,075
(157)
(5.1)
%
Investigation, restatement and related
649
(38)
687
nm
Amortization of intangible assets
192
190
2
1.1
%
Impairment of intangible assets
298
—
298
nm
Interest income (expense), net
278
(1,680)
1,958
nm
Other expense, net
(21)
(11)
(10)
90.9
%
Income tax provision
(3,541)
(591)
(2,950)
nm
Net income from continuing operations
7,878
8,842
(964)
(10.9)
%
Changes noted as “nm” in the table above indicate that the percentage change is not meaningful.
Net Sales
We recorded net sales for the three months ended September 30, 2024 of $84.1 million, a $2.3 million, or 2.9%, increase compared to the three months ended September 30, 2023, in which we recognized net sales of $81.7 million.
Our sales by product line were as follows (amounts in thousands):
Three Months Ended September 30,
Change
2024
2023
$
%
Wound
$
55,052
$
51,156
$
3,896
7.6
%
Surgical
29,005
30,556
(1,551)
(5.1)
%
Total
$
84,057
$
81,712
$
2,345
2.9
%
Net sales of our Wound product portfolio were $55.1 million for the three months ended September 30, 2024, a $3.9 million or 7.6% increase compared to $51.2 million for the three months ended September 30, 2023. The increase was primarily driven by contributions from 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.
Net sales of our Surgical products totaled $29.0 million for the three months ended September 30, 2024, reflecting a decrease of $1.6 million, or 5.1%, compared to $30.6 million for the three months ended September 30, 2023. Sales growth from certain Surgical products, particularly AMNIOEFFECT, as well as initial contributions associated with sales of our recently launched HELIOGEN product, were more than offset by challenges in certain regions where we have recently experienced higher than normal employee turnover and, to a lesser degree, by declines in sales of AXIOFILL during the quarter. In addition, Surgical sales for the three months ended September 30, 2023 includes $1.4 million of sales of our dental product which we have since discontinued.
Cost of Sales and Gross Profit Margin
Cost of sales for the three months ended September 30, 2024 and 2023 was $15.3 million and $14.8 million, respectively, an increase of $0.5 million, or 3.6%, year-over-year. Gross profit margin for the three months ended September 30, 2024 was 81.8% compared to 81.9% for the three months ended September 30, 2023. Increases in cost of sales were driven by increases in sales volume. The year-over-year reduction in gross margin was driven by the amortization of distribution rights stemming from the TELA Asset Purchase Agreement entered into during the first quarter of 2024, as described below. This was partially offset by favorable product mix and our continued execution on yield and scrap improvement projects.
22
Selling, General and Administrative Expense
Selling, general and administrative (“SG&A”) expense for the three months ended September 30, 2024 was $53.5 million, compared to $52.6 million for the three months ended September 30, 2023, an increase of $0.9 million, or 1.8%, year-over-year. The increase in SG&A expense was driven by year-over-year increases in compensation related to higher salary and benefit costs from merit raises and 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, including our ongoing litigation with a competitor and several former employees.
Research and Development Expense
Our research and development (“R&D”) expense for the three months ended September 30, 2024 was $2.9 million, compared to $3.1 million for the three months ended September 30, 2023, an decrease of $0.2 million. 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 (Benefit)
Investigation, restatement and related expense for the three months ended September 30, 2024 was an expense of $0.6 million compared to an immaterial benefit for the three months ended September 30, 2023. The increase resulted from a negotiated reductions in legal fees previously incurred under indemnification agreements with certain former members of management during the three months ended September 30, 2023. This was offset by the last material payment towards the resolution of the historical Audit Committee investigation during the three months ended September 30, 2024. We do not expect activity to be material in future periods.
Amortization of Intangible Assets
Amortization expense related to intangible assets was $0.2 million for each of the three months ended September 30, 2024 and 2023.
Impairment of Intangible Assets
Impairment for the three months ended September 30, 2024 was $0.3 million, which relates to abandoned patents.
Interest Income (Expense), Net
Interest income, net was $0.3 million for the three months ended September 30, 2024 compared to a net interest expense of $1.7 million for the three months ended September 30, 2023. The decrease in interest expense was the result of a reduction in outstanding debt, lower interest rates under the new Citizens Credit Facilities compared to our previous borrowings, and improvements in our treasury management.
Income Tax Provision Expense
The effective tax rates for the Company were 31.0% and 6.3% for the three months ended September 30, 2024 and September 30, 2023, respectively.
The effective tax rate for the three months ended September 30, 2023 reflected a valuation allowance against all of the Company’s deferred tax assets. During the fourth quarter of 2023, we concluded that we were 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 expectations for future taxable income generation, led to a change in our assessment of the realizability of our deferred tax assets. The effective tax rate for the three months ended September 30, 2024 was not influenced by a valuation allowance against deferred tax assets, which had an unfavorable impact on the effective tax rate.
The effective tax rate for the three months ended September 30, 2024 was favorably impacted by restricted stock vestings, offset by executive compensation deduction limitations.
Nine Months Ended September 30, 2024 Compared to the Nine Months Ended September 30, 2023
23
Nine Months Ended September 30,
(in thousands)
2024
2023
$ Change
% Change
Net sales
$
255,972
$
234,645
$
21,327
9.1
%
Cost of sales
43,164
40,792
2,372
5.8
%
Gross profit
212,808
193,853
18,955
9.8
%
Selling, general and administrative
164,044
156,773
7,271
4.6
%
Research and development
8,770
10,232
(1,462)
(14.3)
%
Investigation, restatement and related
(8,741)
4,652
(13,393)
nm
Amortization of intangible assets
572
570
2
0.4
%
Impairment of intangible assets
352
—
352
nm
Interest expense, net
(1,409)
(4,864)
3,455
(71.0)
%
Other expense, net
(357)
(42)
(315)
nm
Income tax provision expense
(11,485)
(569)
(10,916)
nm
Net income from continuing operations
$
34,560
$
16,151
$
18,409
nm
Changes noted as “nm” in the table above indicate that the percentage change is not meaningful.
Net Sales
We recorded net sales for the nine months ended September 30, 2024 of $256.0 million, a $21.3 million, or 9.1%, increase compared to the nine months ended September 30, 2023, for which we recorded net sales of $234.6 million.
Our sales by product were as follows (amounts in thousands):
Nine Months Ended September 30,
Change
2024
2023
$
%
Wound
$
169,647
$
149,681
$
19,966
13.3
%
Surgical
86,325
84,964
1,361
1.6
%
Total
$
255,972
$
234,645
$
21,327
9.1
%
Net sales of our Wound product portfolio were $169.6 million for the nine months ended September 30, 2024, a $20.0 million or 13.3% increase compared to $149.7 million for the nine months ended September 30, 2023. The increase was primarily driven by contributions from EPIEFFECT, which did not have comparative sales for the nine months ended September 30, 2023, partially offset by commercial challenges associated with competitive behavior in the marketplace.
Net sales of our Surgical products totaled $86.3 million, reflecting growth of $1.4 million, or 1.6%, compared to the nine months ended September 30, 2023. The increase was primarily driven by growing volume contributions from AMNIOEFFECT and AMNIOFIX, as well as initial contributions associated with sales of our recently launched HELIOGEN product, partially offset by lower sales of AXIOFILL compared to the prior year period. In addition, Surgical sales for the nine months ended September 30, 2023 reflects approximately $3 million of sales of our dental product which we have since discontinued.
Cost of Sales and Gross Profit Margin
Cost of sales for the nine months ended September 30, 2024 was $43.2 million, an increase of $2.4 million, or 5.8%, compared to $40.8 million for the nine months ended September 30, 2023. Gross profit margin for the nine months ended September 30, 2024 was 83.1% compared to 82.6% for the nine months ended September 30, 2023. Increases in cost of sales were driven by increases in sales volume. The year-over-year improvement in gross margin was driven by favorable product mix and our continued execution on yield and scrap improvement projects, partially offset by the amortization of distribution rights stemming from the TELA Asset Purchase Agreement entered into during the first quarter of 2024.
Selling, General and Administrative Expense
Selling, general and administrative expenses for the nine months ended September 30, 2024 increased $7.3 million, or 4.6%, to $164.0 million, compared to $156.8 million for the nine months ended September 30, 2023. The increase in SG&A expenses
24
was driven by year-over-year increases in compensation related to higher salary and benefit costs from merit raises and 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, including our ongoing litigation with a competitor and several former employees.
Research and Development Expense
Our research and development expenses decreased $1.5 million, or 14.3%, to $8.8 million for the nine months ended September 30, 2024, compared to $10.2 million for the nine months ended September 30, 2023. This decrease was driven primarily by lower headcount and the timing of R&D activities compared to the prior year.
Investigation, Restatement and Related Expense
Investigation, restatement and related expenses for the nine months ended September 30, 2024 was a benefit of $8.7 million compared to expense of $4.7 million for the nine months ended September 30, 2023. The benefit resulted from various settlements related to former officers and other related matters as well as negotiated reductions in legal fees previously incurred under indemnification agreements with certain former members of management during the nine months ended September 30, 2023. This was offset by the last material payment towards the resolution of our historical Audit Committee investigation during the nine months ended September 30, 2024. We do not expect activity to be material in future periods .
Amortization of Intangible Assets
Amortization expense related to intangible assets was $0.6 million for each of the nine months ended September 30, 2023 and 2023.
Impairment of Intangible Assets
Impairment for the nine months ended September 30, 2024 was $0.4 million, which relates to abandoned patents.
Interest Expense, Net
Interest expense, net was $1.4 million for the nine months ended September 30, 2024 compared to $4.9 million for the nine months ended September 30, 2023. The decrease was the result of a decrease in outstanding debt, lower interest rates under the Citizens Credit Facilities, and improvements in our treasury management. The decrease was partially offset by a loss on extinguishment of debt due to repaying and terminating a previous loan agreement during the first quarter of 2024 ($1.4 million).
Income Tax Provision Expense
The effective tax rates for the Company were 24.9% and 3.4% for the nine months ended September 30, 2024 and 2023, respectively.
During the fourth quarter of 2023, we noted that we were 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 expectations for future taxable income generation, led to a change in our assessment of the realizability of our deferred tax assets. Consequently, the effective tax rate for the nine months ended September 30, 2024 was not influenced by a valuation allowance reflected against deferred tax assets, which had an unfavorable impact on the effective tax rate.
The effective tax rate for the nine months ended September 30, 2024 was favorably impacted by vestings of restricted stock units, offset by executive compensation deduction limitations.
Discussion of Cash Flows
Operating Activities
Net cash provided by operating activities from continuing operations during the nine months ended September 30, 2024 was $47.4 million, compared to cash provided by operating activities from continuing operations of $16.5 million for the nine months ended September 30, 2023. The change was primarily the result of year-over-year increases in net sales, which drove increases in collections from customers.
Investing Activities
25
Net cash used for investing activities during the nine months ended September 30, 2024 was $6.8 million, compared to $1.7 million for the nine months ended September 30, 2023. This increase was largely the result of our investment to expand our product portfolio through the TELA and Regenity agreements, as described below in “Liquidity and Capital Resources.”
Financing Activities
Net cash used for financing activities during the nine months ended September 30, 2024 was $33.8 million. Cash provided by financing activities was $0.4 million during the nine months ended September 30, 2023. The cash used during the nine months ended September 30, 2024 was due to the repayment of the initial $30.0 million drawing under the Revolving Credit Facility, as described below in “Liquidity and Capital Resources,” deferred financing costs and other payments made as part of the Debt Refinancing Transactions, as defined below, and stock repurchases for tax withholdings upon vesting of employee stock awards.
Liquidity and Capital Resources
We require capital for our operating activities, including costs associated with the sale of product through direct and indirect sales channels, research and development activities, compliance costs, costs to sell and market our products, regulatory fees, and legal and consulting fees in connection with ongoing litigation and other matters. We generally fund our operating capital requirements through our operating activities and cash reserves. We expect to use capital to invest in the broadening of our product portfolio, including through potential acquisitions, licensing agreements or other arrangements, the international expansion of our business and certain capital projects.
As of September 30, 2024, we had $88.8 million of cash and cash equivalents, total current assets of $172.1 million and total current liabilities of $41.9 million, reflecting a current ratio of 4.1. We had no borrowings outstanding and $75 million of availability under our Revolving Credit Facility (as defined below).
The Company is currently paying its obligations in the ordinary course of business. We believe that our 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 Quarterly Report.
Citizens Credit Facilities
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 was designed to simultaneously improve our capital structure, providing the ability to refinance our prior $50 million senior secured term loan under the Hayfin Loan Agreement (as defined below) at lower interest rates and have access to additional borrowing capacity that could be deployed in the future in support of our organic and potential inorganic growth objectives.
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 our Consolidated EBITDA as defined therein, each subject to the existing or any new lenders’ election to extend additional term loans or revolving commitments.
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. The applicable margin will be determined based on the Company’s consolidated total net leverage ratio.
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. We must make mandatory prepayments in connection with certain asset dispositions and casualty events, subject in each case to customary reinvestment
26
rights. We may prepay borrowings under the Credit Facilities at any time, without premium or penalty, and may, at its option, reduce the aggregate unused commitments under the Revolving Credit Facility in whole or in part, in each case subject to the terms of the Credit Agreement. We must also comply with certain financial covenants, including a maximum total net leverage ratio and a minimum consolidated fixed charge coverage ratio, as well as other customary restrictive covenants. As of September 30, 2024, the Company is in compliance with all financial covenants under the Credit Facilities.
On January 19, 2024, we borrowed $30.0 million under the Revolving Credit Facility and $20.0 million under the Term Loan Facility. Proceeds from the initial drawings under the Credit Facilities, together with cash on hand, were used to repay in full the $50.0 million principal amount and other obligations under that certain Loan Agreement, dated as of June 30, 2020 (as amended from time to time), by and among the Company, the guarantors party thereto, the lenders party thereto and Hayfin Services LLP, as administrative and collateral agent (as amended from time to time, the “Hayfin Loan Agreement”) and to pay related fees, premiums, costs and expenses (collectively with the entry into the Citizens Credit Agreement and the initial borrowings thereunder, the “Debt Refinancing Transactions”).
On February 27, 2024, we repaid the initial $30.0 million drawing under the Revolving Credit Facility.
Contractual Obligations
Except as described below, there were no significant changes to our contractual obligations during the nine months ended September 30, 2024 from those disclosed in the section Item 7, “Management’s Discussion and Analysis of Financial Condition and Results from Operations”, in our 2023 Form 10-K.
TELA and Regenity Agreements
On March 15, 2024, the Company entered into an Asset Purchase Agreement (the “TELA APA”) with TELA Bio, Inc. (“TELA”) and a manufacturing and supply agreement (the “Supply Agreement”) with Regenity Biosciences, Inc. (“Regenity”), adding to the Company’s product portfolio a 510(k)-cleared collagen particulate xenograft product now marketed as HELIOGEN (“HELIOGEN”) indicated for the management of moderately to heavily exudating wounds and to control minor bleeding. Under the terms of the TELA APA, the Company made an initial $5.0 million payment to TELA and will be required to make additional future payments aggregating between a minimum of $3.0 million and a maximum of $7.0 million, based on net sales of HELIOGEN over the next two years from June 2024.
The Supply Agreement maintains MIMEDX’s exclusive right to sell and market HELIOGEN in the United States and requires MIMEDX to purchase a minimum amount of HELIOGEN from Regenity annually through December 31, 2033. Should MIMEDX fail to meet a purchasing minimum in any one period, it has the option (among others) to amend its distribution rights under the Supply Agreement to be non-exclusive.
Critical Accounting Estimates
In preparing financial statements, we follow accounting principles generally accepted in the United States, which require us to make certain estimates and apply judgments that affect our financial position and results of operations. We regularly review our accounting policies and financial information disclosures. A summary of critical accounting estimates in preparing the financial statements was provided in our 2023 Form 10-K.
Recent Accounting Pronouncements
For the effect of recent accounting pronouncements, see Note 2, Significant Accounting Policies, to the unaudited condensed consolidated financial statements contained herein.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
We are exposed to risks associated with changes in interest rates that could adversely affect our results of operations and financial condition. We do not hedge against interest rate risk.
The interest rate on our Term Loan Facility is determined quarterly based on the 1-month term SOFR. As of September 30, 2024, the interest rate on our Term Loan Facility was 7.9%. A 100 basis point change in SOFR would change our interest expense by $0.2 million on an annualized basis.
27
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended, or the Exchange Act) as of the end of the period covered by this report. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures as of the end of the period covered by this report were effective at a reasonable assurance level in ensuring that information required to be disclosed by us in reports that we file or submit under the Exchange Act (i) is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and (ii) accumulated and communicated to management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely discussions regarding required disclosure. We believe that a control system, no matter how well designed and operated, cannot provide absolute assurance that the objectives of the control system are met, and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected.
Changes in Internal Control over Financial Reporting
There was no change in our internal control over financial reporting (as defined in Rule 13a-15(f) and 15d-15(f) of the Exchange Act) that occurred during the fiscal quarter ended September 30, 2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
28
PART II – OTHER INFORMATION
Item 1. Legal Proceedings
The Company and its subsidiaries are parties to numerous claims and lawsuits arising in the ordinary course of its business activities, some of which involve claims for substantial amounts. The ultimate outcome of these suits cannot be ascertained at this time. The description of the Welker v. MiMedx, et. Al case, which was settled in August 2024, contained in Note 12, “Commitments and Contingencies,” to the unaudited condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report, is incorporated herein by reference.
Item 1A. Risk Factors
There have been no material changes to the Company’s risk factors included in its 2023 Form 10-K.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
(a) None.
(b) None.
(c) The following table sets forth information regarding the purchases of the Company’s equity securities made by or on behalf of the Company or any affiliated purchases (as defined in Exchange Act Rule 10b-18) during the three month period ended September 30, 2024:
Total number of shares purchased1
Average price paid per share
Total number of shares purchased under publicly announced plan
Approximate dollar value of shares that may yet be purchased under plans or programs
July 1 - July 31, 2024
31,380
$
7.18
—
$
—
August 1 - August 31, 2024
—
—
—
—
September 1 - September 30, 2024
—
—
—
—
Total for the quarter
31,380
$
7.18
$
—
$
—
(1) Reflect repurchases of shares by the Company upon vesting of employee restricted stock units in order to satisfy tax withholding obligations.
Item 3. Defaults Upon Senior Securities
Not applicable.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
Insider Trading Arrangements and Policies
During the three months ended September 30, 2024, no director or officer of the Company adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.
Previously filed and incorporated herein by reference
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Filed or furnished herewith
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.