QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
(Address of principal executive offices) | (Zip Code) |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
Large accelerated filer ¨ | Non-accelerated filer ¨ | Smaller reporting company | Emerging growth company | |||||||||||
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨ |
Part I FINANCIAL INFORMATION | ||||||||
Item 1 | Financial Statements (Unaudited) | |||||||
Condensed Consolidated Balance Sheets | ||||||||
Condensed Consolidated Statements of Operations | ||||||||
Condensed Consolidated Statements of Stockholders’ (Deficit) Equity | ||||||||
Condensed Consolidated Statements of Cash Flows | ||||||||
Notes to the Condensed Consolidated Financial Statements | ||||||||
Item 2 | Management’s Discussion and Analysis of Financial Condition and Results of Operations | |||||||
Item 3 | Quantitative and Qualitative Disclosures About Market Risk | |||||||
Item 4 | Controls and Procedures | |||||||
Part II OTHER INFORMATION | ||||||||
Item 1 | Legal Proceedings | |||||||
Item 1A | Risk Factors | |||||||
Item 2 | Unregistered Sales of Equity Securities and Use of Proceeds | |||||||
Item 3 | Defaults upon Senior Securities | |||||||
Item 4 | Mine Safety Disclosures | |||||||
Item 5 | Other Information | |||||||
Item 6 | Exhibits | |||||||
Signatures |
March 31, 2023 | December 31, 2022 | ||||||||||
ASSETS | |||||||||||
Current assets: | |||||||||||
Cash and cash equivalents | $ | $ | |||||||||
Accounts receivable, net | |||||||||||
Inventory | |||||||||||
Prepaid expenses | |||||||||||
Other current assets | |||||||||||
Total current assets | |||||||||||
Property and equipment, net | |||||||||||
Right of use asset | |||||||||||
Goodwill | |||||||||||
Intangible assets, net | |||||||||||
Other assets | |||||||||||
Total assets | $ | $ | |||||||||
LIABILITIES, CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS’ DEFICIT | |||||||||||
Current liabilities: | |||||||||||
Accounts payable | $ | $ | |||||||||
Accrued compensation | |||||||||||
Accrued expenses | |||||||||||
Other current liabilities | |||||||||||
Total current liabilities | |||||||||||
Long term debt, net | |||||||||||
Other liabilities | |||||||||||
Total liabilities | $ | $ | |||||||||
Commitments and contingencies (Note 13) | |||||||||||
Convertible preferred stock Series B; $ | $ | $ | |||||||||
Stockholders' deficit | |||||||||||
Preferred stock Series A; $ | $ | $ | |||||||||
Common stock; $ | |||||||||||
Additional paid-in capital | |||||||||||
Treasury stock at cost; | ( | ||||||||||
Accumulated deficit | ( | ( | |||||||||
Total stockholders' deficit | ( | ( | |||||||||
Total liabilities, convertible preferred stock, and stockholders’ deficit | $ | $ |
Three Months Ended March 31, | |||||||||||
2023 | 2022 | ||||||||||
Net sales | $ | $ | |||||||||
Cost of sales | |||||||||||
Gross profit | |||||||||||
Operating expenses: | |||||||||||
Selling, general and administrative | |||||||||||
Research and development | |||||||||||
Investigation, restatement and related | |||||||||||
Amortization of intangible assets | |||||||||||
Operating loss | ( | ( | |||||||||
Other expense, net | |||||||||||
Interest expense, net | ( | ( | |||||||||
Other income, net | |||||||||||
Loss before income tax provision | ( | ( | |||||||||
Income tax provision expense | ( | ( | |||||||||
Net loss | $ | ( | $ | ( | |||||||
Net loss available to common stockholders (Note 9) | $ | ( | $ | ( | |||||||
Net loss per common share - basic | $ | ( | $ | ( | |||||||
Net loss per common share - diluted | $ | ( | $ | ( | |||||||
Weighted average common shares outstanding - basic | |||||||||||
Weighted average common shares outstanding - diluted |
Common Stock Issued | Additional Paid - in | Treasury Stock | Accumulated | ||||||||||||||||||||
Shares | Amount | Capital | Shares | Amount | Deficit | Total | |||||||||||||||||
Balance at December 31, 2022 | $ | $ | $ | $ | ( | $ | ( | ||||||||||||||||
Share-based compensation expense | — | — | — | — | — | ||||||||||||||||||
Employee stock purchase plan | — | — | — | — | |||||||||||||||||||
Issuance of restricted stock | ( | ( | — | ||||||||||||||||||||
Restricted stock shares canceled/forfeited | — | — | ( | — | |||||||||||||||||||
Net loss | — | — | — | — | — | ( | ( | ||||||||||||||||
Balance at March 31, 2023 | $ | $ | $ | ( | $ | ( | $ | ( |
Common Stock Issued | Additional Paid - in | Treasury Stock | Accumulated | ||||||||||||||||||||
Shares | Amount | Capital | Shares | Amount | Deficit | Total | |||||||||||||||||
Balance at December 31, 2021 | $ | $ | $ | ( | $ | ( | $ | ||||||||||||||||
Share-based compensation expense | — | — | — | — | — | ||||||||||||||||||
Exercise of stock options | — | — | ( | ( | — | ||||||||||||||||||
Issuance of restricted stock | ( | ( | — | ||||||||||||||||||||
Restricted stock shares canceled/forfeited | — | — | ( | — | |||||||||||||||||||
Shares repurchased for tax withholding | — | — | — | ( | — | ( | |||||||||||||||||
Net loss | — | — | — | — | — | ( | ( | ||||||||||||||||
Balance at March 31, 2022 | $ | $ | $ | ( | $ | ( | $ | ( |
Three Months Ended March 31, | |||||||||||
2023 | 2022 | ||||||||||
Cash flows from operating activities: | |||||||||||
Net loss | $ | ( | $ | ( | |||||||
Adjustments to reconcile net loss to net cash flows used in operating activities: | |||||||||||
Share-based compensation | |||||||||||
Depreciation | |||||||||||
Non-cash lease expenses | |||||||||||
Amortization of intangible assets | |||||||||||
Amortization of deferred financing costs | |||||||||||
Accretion of asset retirement obligation | |||||||||||
Gain on fixed asset disposal | ( | ||||||||||
Bad debt expense | ( | ||||||||||
Increase (decrease) in cash resulting from changes in: | |||||||||||
Accounts receivable | ( | ||||||||||
Inventory | ( | ( | |||||||||
Prepaid expenses | ( | ||||||||||
Other assets | ( | ||||||||||
Accounts payable | ( | ||||||||||
Accrued compensation | ( | ( | |||||||||
Accrued expenses | |||||||||||
Other liabilities | ( | ( | |||||||||
Net cash flows used in operating activities | ( | ( | |||||||||
Cash flows from investing activities: | |||||||||||
Purchases of equipment | ( | ( | |||||||||
Patent application costs | ( | ( | |||||||||
Proceeds from sale of equipment | |||||||||||
Net cash flows used in investing activities | ( | ( | |||||||||
Cash flows from financing activities: | |||||||||||
Principal payments on finance lease | ( | ( | |||||||||
Stock repurchased for tax withholdings on vesting of restricted stock | ( | ||||||||||
Proceeds from exercise of stock options | |||||||||||
Net cash flows used in financing activities | ( | ( | |||||||||
Net change in cash | ( | ( | |||||||||
Cash and cash equivalents, beginning of period | |||||||||||
Cash and cash equivalents, end of period | $ | $ |
March 31, 2023 | December 31, 2022 | ||||||||||
Accounts receivable, gross | $ | $ | |||||||||
Less: allowance for doubtful accounts | ( | ( | |||||||||
Accounts receivable, net | $ | $ |
Allowance for Doubtful Accounts | |||||
Balance at December 31, 2022 | $ | ||||
Bad debt expense | ( | ||||
Write-offs | ( | ||||
Balance at March 31, 2023 | $ |
March 31, 2023 | December 31, 2022 | ||||||||||
Raw materials | $ | $ | |||||||||
Work in process | |||||||||||
Finished goods | |||||||||||
Inventory | $ | $ |
March 31, 2023 | December 31, 2022 | ||||||||||
Laboratory and clean room equipment | $ | $ | |||||||||
Furniture and equipment | |||||||||||
Leasehold improvements | |||||||||||
Construction in progress | |||||||||||
Asset retirement cost | |||||||||||
Finance lease right-of-use asset | |||||||||||
Property and equipment, gross | |||||||||||
Less: accumulated depreciation and amortization | ( | ( | |||||||||
Property and equipment, net | $ | $ |
Three Months Ended March 31, | |||||||||||
2023 | 2022 | ||||||||||
Depreciation expense | $ | $ |
March 31, 2023 | December 31, 2022 | ||||||||||||||||||||||
Gross Carrying Amount | Accumulated Amortization | Net Carrying Amount | Gross Carrying Amount | Accumulated Amortization | Net Carrying Amount | ||||||||||||||||||
Amortized intangible assets | |||||||||||||||||||||||
Patents and know-how | $ | $ | ( | $ | $ | $ | ( | $ | |||||||||||||||
Licenses | ( | ( | $ | ||||||||||||||||||||
Total amortized intangible assets | $ | $ | ( | $ | $ | $ | ( | $ | |||||||||||||||
Unamortized intangible assets: | |||||||||||||||||||||||
Tradenames and trademarks | $ | $ | $ | $ | |||||||||||||||||||
Patents in Process | |||||||||||||||||||||||
Total intangible assets | $ | $ | $ | $ |
Three Months Ended March 31, | |||||||||||
2023 | 2022 | ||||||||||
Amortization expense | $ | $ | |||||||||
Year ending December 31, | Estimated Amortization Expense | ||||
2023 (excluding the three months ended March 31, 2023) | $ | ||||
2024 | |||||
2025 | |||||
2026 | |||||
2027 | |||||
Thereafter | |||||
Total amortized intangible assets | $ |
March 31, 2023 | December 31, 2022 | ||||||||||
Legal and settlement costs | $ | $ | |||||||||
Commissions to sales agents | |||||||||||
Accrued rebates | |||||||||||
Accrued group purchasing organization fees | |||||||||||
Estimated sales returns | |||||||||||
Accrued travel | |||||||||||
Accrued clinical trials | |||||||||||
Other | |||||||||||
Accrued expenses | $ | $ |
March 31, 2023 | December 31, 2022 | ||||||||||
Outstanding principal | $ | $ | |||||||||
Deferred financing costs | ( | ( | |||||||||
Original issue discount | ( | ( | |||||||||
Long term debt, net | $ | $ |
Three Months Ended March 31, | |||||||||||
2023 | 2022 | ||||||||||
Stated interest | $ | $ | |||||||||
Amortization of deferred financing costs | |||||||||||
Accretion of original issue discount | |||||||||||
Interest expense | $ | $ |
Year ending December 31, | Principal | ||||
2023 (excluding the three months ended March 31, 2023) | $ | ||||
2024 | |||||
2025 | |||||
2026 | |||||
2027 | |||||
Thereafter | |||||
Outstanding principal | $ |
Three Months Ended March 31, | |||||||||||
2023 | 2022 | ||||||||||
Net loss | $ | ( | $ | ( | |||||||
Accumulated dividends on Series B Preferred Stock | |||||||||||
Net loss available to common stockholders | $ | ( | $ | ( | |||||||
Weighted average common shares outstanding | |||||||||||
Basic net loss per common share | $ | ( | $ | ( |
Three Months Ended March 31, | |||||||||||
2023 | 2022 | ||||||||||
Net loss available to common stockholders | $ | ( | $ | ( | |||||||
Adjustments: | |||||||||||
Accumulated dividends on Series B Convertible Preferred Stock | |||||||||||
Less: antidilutive adjustments | ( | ( | |||||||||
Total adjustments | — | — | |||||||||
Numerator | $ | ( | $ | ( | |||||||
Weighted average shares outstanding | |||||||||||
Adjustments | |||||||||||
Potential common shares | |||||||||||
Less: antidilutive potential common shares (a) | ( | ( | |||||||||
Total adjustments | — | — | |||||||||
Weighted average shares outstanding adjusted for potential common shares | |||||||||||
Diluted net loss per common share | $ | ( | $ | ( |
Three Months Ended March 31, | |||||||||||
2023 | 2022 | ||||||||||
Series B Convertible Preferred Stock | |||||||||||
Restricted stock unit awards | |||||||||||
Restricted stock awards | |||||||||||
Employee stock purchase plan | |||||||||||
Performance stock unit awards | |||||||||||
Outstanding stock options | |||||||||||
Potential common shares |
RSA | RSU | PSU | ||||||||||||||||||||||||
Number of Shares | Weighted-Average Grant Date Fair Value | Number of Shares | Weighted-Average Grant Date Fair Value | Number of Shares | Weighted-Average Grant Date Fair Value | |||||||||||||||||||||
Unvested at January 1, 2023 | $ | $ | $ | |||||||||||||||||||||||
Granted | ||||||||||||||||||||||||||
Vested | ( | |||||||||||||||||||||||||
Forfeited | ( | ( | ( | |||||||||||||||||||||||
Unvested at March 31, 2023 | $ | $ | $ |
Number of Shares | Weighted- Average Exercise Price | Weighted- Average Remaining Contractual Term (in years) | Aggregate Intrinsic Value | ||||||||||||||||||||
Outstanding at January 1, 2023 | $ | ||||||||||||||||||||||
Granted | |||||||||||||||||||||||
Exercised | |||||||||||||||||||||||
Unvested options forfeited | |||||||||||||||||||||||
Vested options expired | ( | ||||||||||||||||||||||
Outstanding at March 31, 2023 | |||||||||||||||||||||||
Exercisable at March 31, 2023 | $ | $ |
Assumption | |||||
Stock price on grant date | $ | ||||
Exercise price | $ | ||||
Risk-free interest rate | % | ||||
Expected volatility (annualized) | % | ||||
Dividend yield | % | ||||
Weighted average grant date fair value | $ |
Three Months Ended March 31, | |||||||||||
2023 | 2022 | ||||||||||
Cash paid for interest | $ | $ | |||||||||
Cash paid for income taxes | |||||||||||
Non-cash activities: | |||||||||||
Purchases of equipment in accounts payable | |||||||||||
Issuance of shares pursuant to employee stock purchase plan | |||||||||||
Right of use assets arising from operating lease liabilities | ( | ||||||||||
Three Months Ended March 31, | |||||||||||
2023 | 2022 | ||||||||||
Advanced Wound Care | |||||||||||
Tissue/Other | $ | $ | |||||||||
Cord | |||||||||||
Total Advanced Wound Care | |||||||||||
Section 351(1) | |||||||||||
Total | $ | $ |
Three Months Ended March 31, | |||||||||||
2023 | 2022 | ||||||||||
Hospital | $ | $ | |||||||||
Private Office | |||||||||||
Other | |||||||||||
Total | $ | $ | |||||||||
Wound & Surgical | Regenerative Medicine | Corporate & Other | Consolidated | ||||||||||||||||||||
Net sales | $ | $ | $ | ||||||||||||||||||||
Cost of sales | |||||||||||||||||||||||
Selling, general and administrative expense | |||||||||||||||||||||||
Research and development expense | |||||||||||||||||||||||
Amortization of intangible assets | |||||||||||||||||||||||
Segment contribution | $ | $ | ( | ||||||||||||||||||||
Investigation, restatement and related expense | |||||||||||||||||||||||
Operating loss | $ | ( | |||||||||||||||||||||
Supplemental information | |||||||||||||||||||||||
Depreciation expense | $ | $ | $ | $ | |||||||||||||||||||
Share-based compensation | $ | $ | $ | $ |
Wound & Surgical | Regenerative Medicine | Corporate & Other | Consolidated | ||||||||||||||||||||
Net sales | $ | $ | $ | $ | |||||||||||||||||||
Cost of sales | |||||||||||||||||||||||
Selling, general and administrative expense | |||||||||||||||||||||||
Research and development expense | |||||||||||||||||||||||
Amortization of intangible assets | |||||||||||||||||||||||
Segment contribution | $ | $ | ( | ||||||||||||||||||||
Investigation, restatement and related expense | |||||||||||||||||||||||
Operating loss | $ | ( | |||||||||||||||||||||
Supplemental information | |||||||||||||||||||||||
Depreciation expense | $ | $ | $ | $ | |||||||||||||||||||
Share-based compensation | $ | $ | $ | $ |
Three Months Ended March 31, | |||||||||||||||||||||||
(in thousands) | |||||||||||||||||||||||
2023 | 2022 | $ Change | % Change | ||||||||||||||||||||
Net sales | $ | 71,676 | $ | 58,894 | $ | 12,782 | 21.7 | % | |||||||||||||||
Cost of sales | 12,419 | 9,936 | 2,483 | 25.0 | % | ||||||||||||||||||
Gross profit | 59,257 | 48,958 | 10,299 | 21.0 | % | ||||||||||||||||||
Selling, general and administrative | 52,279 | 49,570 | 2,709 | 5.5 | % | ||||||||||||||||||
Research and development | 6,496 | 5,964 | 532 | 8.9 | % | ||||||||||||||||||
Investigation, restatement and related | 3,673 | 2,552 | 1,121 | 43.9 | % | ||||||||||||||||||
Amortization of intangible assets | 190 | 172 | 18 | 10.5 | % | ||||||||||||||||||
Interest expense, net | (1,553) | (1,126) | (427) | 37.9 | % | ||||||||||||||||||
Income tax provision expense | (51) | (63) | 12 | (19.0) | % | ||||||||||||||||||
Net loss | $ | (4,983) | $ | (10,489) | $ | 5,506 | (52.5) | % |
Three Months Ended March 31, | Change | ||||||||||||||||||||||
2023 | 2022 | $ | % | ||||||||||||||||||||
Hospital | $ | 42,171 | $ | 35,981 | $ | 6,190 | 17.2 | % | |||||||||||||||
Private Office | 21,487 | 16,157 | 5,330 | 33.0 | % | ||||||||||||||||||
Other | 8,018 | 6,756 | 1,262 | 18.7 | % | ||||||||||||||||||
Total | $ | 71,676 | $ | 58,894 | $ | 12,782 | 21.7 | % | |||||||||||||||
Three Months Ended March 31, | |||||||||||||||||||||||
(in thousands) | |||||||||||||||||||||||
2023 | 2022 | $ Change | % Change | ||||||||||||||||||||
Net sales | $ | 70,629 | $ | 58,330 | $ | 12,299 | 21.1 | % | |||||||||||||||
Cost of sales | 11,332 | 9,129 | 2,203 | 24.1 | % | ||||||||||||||||||
Selling, general and administrative expense | 37,666 | 34,044 | 3,622 | 10.6 | % | ||||||||||||||||||
Research and development expense | 1,522 | 1,951 | (429) | (22.0) | % | ||||||||||||||||||
Segment contribution | $ | 20,109 | $ | 13,206 | $ | 6,903 | 52.3 | % |
Three Months Ended March 31, | |||||||||||||||||||||||
(in thousands) | |||||||||||||||||||||||
2023 | 2022 | $ Change | % Change | ||||||||||||||||||||
Research and development expense | $ | 4,974 | $ | 4,013 | $ | 961 | 23.9 | % | |||||||||||||||
Segment contribution | $ | (4,974) | $ | (4,013) | $ | (961) | 23.9 | % |
Three Months Ended March 31, | |||||||||||
2023 | 2022 | ||||||||||
Net loss | $ | (4,983) | $ | (10,489) | |||||||
Net margin | (7.0) | % | (17.8) | % | |||||||
Non-GAAP Adjustments: | |||||||||||
Depreciation expense | 714 | 860 | |||||||||
Amortization of intangible assets | 190 | 172 | |||||||||
Interest expense, net | 1,553 | 1,126 | |||||||||
Income tax provision | 51 | 63 | |||||||||
EBITDA | (2,475) | (8,268) | |||||||||
EBITDA margin | (3.5) | % | (14.0) | % | |||||||
Additional Non-GAAP Adjustments | |||||||||||
Investigation, restatement and related expenses | 3,673 | 2,552 | |||||||||
Share-based compensation | 4,345 | 3,998 | |||||||||
Adjusted EBITDA | $ | 5,543 | $ | (1,718) | |||||||
Adjusted EBITDA margin | 7.7 | % | (2.9) | % | |||||||
Assumption | |||||
Stock price on grant date | $ | 3.70 | |||
Exercise price | $ | 3.70 | |||
Risk-free interest rate | 3.58 | % | |||
Expected volatility (annualized) | 75.00 | % | |||
Dividend yield | — | % | |||
Weighted average grant date fair value | $ | 1.93 |
Exhibit Number | Description | |||||||
3.1* | Amended and Restated Bylaws of MiMedx Group, Inc., as amended and restated as of February 16, 2023 (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed on February 23, 2023). | |||||||
10.1* | Employment Offer Letter between MiMedx Group, Inc. and Ricci S. Whitlow dated December 27, 2022 (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on January 3, 2023). | |||||||
10.2* | Letter Agreement between MiMedx Group, Inc. and Joseph H. Capper dated January 27, 2023 (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on January 27, 2023). | |||||||
10.3* | Performance Stock Unit Agreement between MiMedx Group, Inc. and Joseph H. Capper dated January 27, 2023 (incorporated by reference to Exhibit 10.3 to the Registrant’s Current Report on Form 8-K filed on January 27, 2023). | |||||||
10.4* | Nonqualified Stock Option Agreement between MiMedx Group, Inc. and Joseph H. Capper dated January 27, 2023 (incorporated by reference to Exhibit 10.4 to the Registrant’s Current Report on Form 8-K filed on January 27, 2023). | |||||||
31.1 # | Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |||||||
31.2 # | Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |||||||
32.1 # | Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |||||||
32.2 # | Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |||||||
101.INS # | XBRL Instance Document | |||||||
101.SCH # | XBRL Taxonomy Extension Schema Document | |||||||
101.CAL # | XBRL Taxonomy Extension Calculation Linkbase Document | |||||||
101.DEF # | XBRL Taxonomy Extension Definition Linkbase Document | |||||||
101.LAB # | XBRL Taxonomy Extension Label Linkbase Document | |||||||
101.PRE # | XBRL Taxonomy Extension Presentation Linkbase Document |
* | Previously filed and incorporated herein by reference | ||||
# | Filed or furnished herewith |
May 2, 2023 | MIMEDX GROUP, INC. | |||||||
By: | /s/ Peter M. Carlson | |||||||
Peter M. Carlson | ||||||||
Chief Financial Officer and Principal Financial Officer |
Date: | May 2, 2023 | /s/Joseph H. Capper | ||||||
Joseph H. Capper | ||||||||
Chief Executive Officer |
Date: | May 2, 2023 | /s/ Peter M. Carlson | ||||||
Peter M. Carlson | ||||||||
Chief Financial Officer |
Date: | May 2 , 2023 | /s/ Joseph H. Capper | ||||||
Joseph H. Capper | ||||||||
Chief Executive Officer |
Date: | May 2, 2023 | /s/ Peter M. Carlson | ||||||
Peter M. Carlson | ||||||||
Chief Financial Officer |
Nature of Business |
3 Months Ended |
---|---|
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Business | Nature of Business MiMedx Group, Inc. (together with its subsidiaries, except where the context otherwise requires, “MIMEDX,” or the “Company”) is a pioneer and leader in placental biologics focused on addressing the needs of patients with acute and chronic non-healing wounds. The Company is also advancing a promising late-stage biologics pipeline targeted at decreasing pain and improving function of patients with knee osteoarthritis (“KOA”). To accomplish these goals, the Company operates as two defined, internal business units: Wound & Surgical and Regenerative Medicine. All of the Company’s products sold in the United States are regulated by the United States Food & Drug Administration (“FDA”). The Company’s business is focused primarily on the United States of America but the Company is pursuing opportunities for international expansion, with specific focus on the sale of its placental tissue products in Japan.
|
Significant Accounting Policies |
3 Months Ended |
---|---|
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | Significant Accounting PoliciesPlease see Note 2, Significant Accounting Policies, to the Company’s Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 (the “2022 Form 10-K”), filed with the Securities and Exchange Commission (“SEC”) on February 28, 2023 for a description of all significant accounting policies. Basis of Presentation The unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments considered necessary for a fair presentation of the results of operations for the periods presented have been included. The operating results for the three months ended March 31, 2023 and 2022 are not necessarily indicative of the results that may be expected for the full fiscal year. The balance sheet as of December 31, 2022 was derived from the audited consolidated financial statements at that date, but does not include all of the information and footnotes required by GAAP for complete financial statements. These unaudited condensed consolidated financial statements should be read in conjunction with the historical consolidated financial statements of the Company included in the 2022 Form 10-K. Reclassifications Increase in cash resulting from changes in income taxes of $0.1 million for the three months ended March 31, 2022, which was separately presented in the unaudited condensed consolidated statement of cash flows in previously-issued financial statements, is included as part of increases and decreases in cash resulting from changes in other assets in the unaudited condensed consolidated statement of cash flows included as part of these financial statements. Principles of Consolidation The consolidated financial statements include the accounts of MiMedx Group, Inc. and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated upon consolidation. Use of Estimates GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported consolidated statements of operations during the reporting period. Actual results could differ from those estimates. Significant estimates include estimated useful lives and potential impairment of property and equipment, estimates of impairment for goodwill and intangible assets, estimates of loss for contingent liabilities, estimate of allowance for doubtful accounts, management’s assessment of the Company’s ability to continue as a going concern, estimate of fair value and the probable achievement of share-based payments, estimates of returns and allowances, and valuation of deferred tax assets. Share-Based Compensation The Company grants share-based awards to employees and members of the Company’s Board of Directors (the “Board”). Awards to employees and the Board are generally made annually. Grants are issued outside of the annual cadence for certain new hires, promotions, and other events. The amount of expense to be recognized is determined by the fair value of the award using inputs available as of the grant date. The fair value of non-option share awards that are not subject to a market condition is the value of the common stock on the grant date. For non-option share awards that are subject to a market condition, the fair value of the common stock on the grant date is adjusted to reflect the value of the market condition, generally using a path-dependent pricing model, such as a Monte Carlo simulation. The fair value of stock option grants is estimated using an option pricing model, as appropriate based on the terms of the grant. Use of a valuation model requires management to make certain assumptions with respect to selected model inputs, which generally follows the inputs to a Black-Scholes option pricing model. Absent the availability of an option market with similar terms to the awarded options, the Company uses the historical volatility of daily price changes in its share price for a period equal to the contractual or expected term of the option, as applicable, subject to adjustment for price activity associated with certain events which are not expected to recur during the relevant term to infer an expectation of volatility. The expected term is derived based on the Company’s expectations for option exercise by the recipients. The Company uses U.S. Treasury yields with a maturity similar to the expected or contractual term, as applicable, as the basis for its risk-free interest rate assumption. The Company has never declared a dividend on its common stock and, therefore, assumes a dividend yield of 0%. For awards with service-based vesting conditions only, the Company recognizes share-based compensation expense on a straight-line basis through the vesting date of the last tranche of the award. For awards which vest based on more than a service condition, the Company recognizes share-based compensation expense using a graded-vesting method, treating each tranche as if it were a separately-granted award and recognizing expense through the vesting date of each individual tranche. In each scenario, the Company recognizes share-based compensation expense to the extent associated service and performance conditions are considered probable to occur. Determinations of probability are made during each reporting period and use available evidence considered relevant for the particular performance condition. The Company recognizes the cumulative effect of changes in the probability of occurrence in the period of re-evaluation. The probability and ultimate resolution of market conditions is not considered in expense recognition. Consequently, the Company could recognize expense for awards that do not ultimately vest. Basic and Diluted Net Loss Per Common Share Basic net loss per common share is calculated as net loss available to common stockholders divided by the weighted average common shares outstanding for the applicable period. Net loss available to common stockholders is calculated by adjusting net loss for periodic accumulated dividends on the Company’s Series B Convertible Preferred Stock (“Series B Preferred Stock”). This amount is divided by the weighted average common shares outstanding during the period. Weighted average common shares outstanding is calculated as shares of the Company outstanding adjusted for the portion of the period for which they are outstanding. Unvested non-option share awards are excluded from the calculation of weighted average common shares outstanding until they have vested. Unvested stock options are excluded from the calculation of weighted average common shares outstanding until they are exercised. Shares issuable pursuant to the Company’s Employee Stock Purchase Plan (“ESPP”) are included for the minimum number of shares issuable beginning at the point in time that all contingencies for share issuance are resolved. Diluted net loss per common share adjusts basic net loss per common share for convertible securities, options, equity incentive awards, and other share-based payment awards which have yet to vest and vest only on the satisfaction of a service condition. Equity incentive awards and options that are subject to a performance or market condition are included only if the performance or market condition would be satisfied if the end of the applicable period were the end of the performance period. In any case, these adjustments are reflected in the calculation of diluted net loss per common share to the extent that they reduce basic net loss per common share. The Company uses the if-converted method to calculate the dilutive effect of the Series B Preferred Stock and other convertible securities to the extent they are outstanding. The if-converted method assumes that convertible securities are converted at the later of the issuance date and the beginning of the period. If the hypothetical conversion of convertible securities, and the consequential avoidance of any accumulated preferred dividends, would decrease basic net loss per common share, these effects are incorporated in the calculation of diluted net loss per common share, adjusted for the portion of the period the securities were outstanding. The Company uses the treasury stock method to calculate the dilutive effect of options, non-option share awards, and certain other share-based payments. The treasury stock method assumes that the proceeds from exercise are used to repurchase common shares at the weighted average market price during the period, increasing the denominator for the net effect of shares issued upon exercise less hypothetical shares repurchased. Share-based payment awards which are subject to a performance or market condition are included if or to the extent that the applicable performance or market condition has been resolved as if the end of the applicable reporting period were the end of the applicable performance period. Shares issuable pursuant to the ESPP are included in the calculation of diluted net loss per common share to the extent that such shares would be issued based on the share price at the conclusion of the period, to the extent such shares are not already included in the calculation of weighted average common shares outstanding. Recently Issued Accounting Standards Not Yet Adopted All ASUs issued and not yet effective for the three months ended March 31, 2023, and through the date of this report, were assessed and determined to be either not applicable or are expected to have minimal impact on the Company’s financial position and results of operations.
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Accounts Receivable, Net |
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Receivables [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accounts Receivable, Net | Accounts Receivable, Net Accounts receivable, net, consisted of the following (in thousands):
Activity related to the Company’s allowance for doubtful accounts for the three months ended March 31, 2023 was as follows (in thousands):
Bad debt expense and write-offs were not material for the three months ended March 31, 2022.
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Inventory |
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Inventory Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory | InventoryInventory consisted of the following (in thousands):
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Property and Equipment, Net |
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Property, Plant and Equipment [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property and Equipment, Net | Property and Equipment, Net Property and equipment, net, consisted of the following (in thousands):
Depreciation expense for the three months ended March 31, 2023 and 2022 is summarized in the table below (in thousands):
Depreciation expense is allocated amongst cost of sales, research and development expense, and selling, general, and administrative expense on the unaudited condensed consolidated statements of operations.
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Intangible Assets, Net |
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Goodwill and Intangible Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Intangible Assets, Net | Intangible Assets, Net Intangible assets, net, are summarized as follows (in thousands):
Amortization expense three months ended March 31, 2023 and 2022 is summarized in the table below (in thousands):
Expected future amortization of intangible assets as of March 31, 2023, is as follows (in thousands):
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Accrued Expenses |
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Accrued Expenses | Accrued Expenses Accrued expenses consisted of the following (in thousands):
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Long Term Debt, Net |
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Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Long Term Debt, Net | Long Term Debt, Net Hayfin Loan Agreement On June 30, 2020, the Company entered into a Loan Agreement with, among others, Hayfin Services, LLP (“Hayfin”), an affiliate of Hayfin Capital Management LLP (the “Hayfin Loan Agreement”), which Hayfin funded on July 2, 2020, providing the Company with a senior secured term loan in an aggregate amount of $50.0 million (the “Term Loan”). On February 28, 2022, the Company executed an Amendment to the Hayfin Loan Agreement (as amended, the “Amended Hayfin Loan Agreement”). The Term Loan matures on June 30, 2025 (the “Maturity Date”). Interest on any borrowings under the Amended Hayfin Loan Agreement is equal to the London Interbank Offered Rate (“LIBOR”), subject to a floor of 1.5%, plus a margin of 6.75% per annum (the “Margin”). If LIBOR is unavailable, the Term Loan will carry interest equal to the Margin plus the greatest of the Prime Rate, the Federal Funds Rate plus 0.5%, and 2.5%. The Term Loan carried an interest rate of 11.9% as of March 31, 2023. As of March 31, 2023, the Company is in compliance with all applicable financial covenants under the Amended Hayfin Loan Agreement. A breach of a financial covenant in the Amended Hayfin Loan Agreement, if uncured or unable to be cured, would likely result in an event of default that could trigger the lender’s remedies, including acceleration of the entire principal balance of the loan as well as any applicable prepayment premiums. The balances of the Term Loan as of March 31, 2023 and December 31, 2022 were as follows (in thousands):
Interest expense related to the Term Loan, included in interest expense, net in the unaudited condensed consolidated statements of operations, was as follows (amounts in thousands):
A summary of principal payments due on the Term Loan, by year, from March 31, 2023 through maturity are as follows (in thousands):
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Net Loss Per Common Share |
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Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net Loss Per Common Share | Net Loss Per Common ShareNet loss per common share is calculated using two methods: basic and diluted. Basic Net Loss Per Common Share The following table provides a reconciliation of net loss to net loss available to common stockholders and calculation of basic net loss per common share for each of the three months ended March 31, 2023 and 2022 (in thousands, except share and per share amounts):
The following table sets forth the computation of diluted net loss per common share (in thousands, except share and per share amounts):
(a) Weighted average common shares outstanding for the calculation of diluted net loss per common share does not include the following adjustments for potential common shares below because their effects were determined to be antidilutive for the periods presented.
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Equity |
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Equity [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Equity | Equity Series B Convertible Preferred Stock The Company has not declared or paid any dividends on the Series B Preferred Stock since issuance. Dividends accumulated but not paid as of March 31, 2023 were $15.5 million. As this amount has not been declared, the Company has not recorded this amount on its unaudited condensed consolidated balance sheet as of March 31, 2023. Based on accumulated dividends as of March 31, 2023, the Series B Preferred Stock was convertible into an aggregate of 29,997,271 shares of the Company’s common stock as of that date. Equity Incentive Awards The Company has issued restricted stock awards (“RSAs”), restricted stock unit awards (“RSUs”), and performance stock unit awards (“PSUs”, collectively the “Equity Incentive Awards”) to its employees. The following is summary information for Equity Incentive Awards for the three months ended March 31, 2023. As of March 31, 2023, there was $34.8 million of unrecognized share-based compensation expense related to share-based payment arrangements. This expense is expected to be recognized over a weighted-average period of 2.58 years, which approximates the remaining vesting period of these grants. The below table summarizes activity of unvested Equity Incentive Awards by award type from January 1, 2023 through March 31, 2023.
Stock Options A summary of stock option activity for the three months ended March 31, 2023 is presented below:
CEO Performance Grant On January 27, 2023, the Board of Directors appointed Joseph H. Capper to serve as Chief Executive Officer. The Company entered into a Letter Agreement with Mr. Capper that included, among other things, a grant of 3,300,000 PSUs (the “CEO Performance PSUs”) and a non-qualified stock option (the “CEO Performance Option”, collectively with the CEO Performance PSUs, the “CEO Performance Grant”) for 3,600,000 shares of the Company’s common stock. In addition to continued employment with the Company, the occurrence and extent of vesting of each component of the CEO Performance Grant is dependent upon the Company’s operating and share price performance: the CEO Performance PSUs vest on the basis of achieved revenue growth, while the CEO Performance Option vests on the basis of share price appreciation. CEO Performance PSUs The CEO Performance PSUs vest in a single tranche on the earlier of the filing date of the Company’s 2026 Annual Report on Form 10-K and March 15, 2027. The occurrence and extent of vesting depends on the Company’s compound annual growth rate (“CAGR”) achieved with respect to its revenue growth between the year ended December 31, 2022 and the year ending December 31, 2026. The PSUs may vest with respect to 50% to 200% of the granted number of PSUs, depending on the extent of CAGR achievement. Failure to achieve the CAGR associated with 50% of achievement would result in no vesting. Management determined the probable level of vesting using internally-developed forecasts for the relevant period representing the Company’s best estimate for revenue, with a factor applied to calculate the highest level of CAGR evaluated to be probable of occurring based on that estimate. The Company recognized $0.3 million of expense related to the CEO Performance PSUs during the three months ended March 31, 2023. CEO Performance Option The CEO Performance Option grants Mr. Capper the right to purchase up to 3,600,000 shares of common stock for $3.70 per share. The CEO Performance Option vests based on the satisfaction of service and market conditions. Mr. Capper may vest in 25% of the CEO Performance Option on each of the first four anniversary dates of the date of grant provided that he remains employed by the Company and provided that specified share price goals are achieved at any point between the date of grant and January 31, 2027. There are three separate share price goals associated with the CEO Performance Option. If specified share price goals are met at one level, one-third of the option may vest, at a second level, a further one-third may vest, and at a third level, the full amount of the option may vest. Satisfaction of the share price goals is based on the average of the closing price of the Company’s common stock during any 20 consecutive trading days through January 31, 2027 exceeding the stipulated share price goal. The CEO Performance Option expires on February 1, 2030. The Company estimated the fair value of the awards using a Monte Carlo simulation using the following assumptions:
The risk-free interest rate was derived based on the U.S. Treasury Yield curve in effect at the date of grant for maturities of similar periods to the contractual term. The expected volatility was estimated principally based on the Company’s historical daily stock price movements for a term similar in length to the contractual term. The dividend yield was based on the Company’s history of dividends on its common stock. The fair value was determined using an expected term which reflects the anticipated holding and post-vesting behavior pattern, calculated for each individual simulation. The total grant date fair value of the CEO Performance Option was $7.0 million. The fair value associated with each tranche of the award will be recognized, straight-line, over the associated requisite service period for that tranche, subject to acceleration if the market condition is met prior to the end of the derived service period. Failure to meet the market condition for an award does not result in reversal of previously-recognized expense, so long as the service is provided for the duration of the required service period. The Company recognized $0.5 million of expense related to the CEO Performance Option during the three months ended March 31, 2023.
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Income Taxes |
3 Months Ended |
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Mar. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income TaxesThe effective tax rates for the Company were (1.0)% and (0.6)% for the three months ended March 31, 2023 and 2022, respectively. There were no material discrete items affecting the effective tax rate in any period. Net operating losses incurred were offset by a valuation allowance. |
Supplemental Disclosure of Cash Flow and Non-cash Investing and Financing Activities |
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Supplemental Disclosure of Cash Flow and Non-cash Investing and Financing Activities | Supplemental Disclosure of Cash Flow and Non-cash Investing and Financing Activities Selected cash payments, receipts, and non-cash activities are as follows (in thousands):
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Commitments and Contingencies |
3 Months Ended |
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Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Separation Agreement with Timothy R. Wright On September 15, 2022, the Company entered into a Separation Agreement and General Release with Timothy R. Wright, the former Chief Executive Officer of the Company (the “Separation Agreement”). Pursuant to the terms of the Separation Agreement and Mr. Wright’s general release of all claims against the Company, the Company will pay Mr. Wright a total of $3.1 million in cash in a series of installments through September 2024. Of the $3.1 million, $0.9 million was paid during the three months ended March 31, 2023. $1.6 million, reflecting payments owed to Mr. Wright within one year, is reflected in accrued compensation together with the remaining $0.6 million reflected in other liabilities in the unaudited condensed consolidated balance sheet as of March 31, 2023. Nordic Agreement In June 2022, the Company entered into a collaboration agreement (the “Nordic Agreement”) with Nordic Bioscience Clinical Development A/S (“NBCD”) to provide full operational support for the Company’s KOA clinical trial program. Under the terms of the Nordic Agreement, the Company is obligated to pay $10.2 million upon the achievement of specified milestones over the course of the clinical trial. As of March 31, 2023, the Company has paid $3.6 million under the Nordic Agreement, relating to milestones which have been achieved from inception through that date. During the three months ended March 31, 2023, the Company recognized $0.6 million of expense. This amount is included as part of research and development expense in the unaudited condensed consolidated statements of operations for those periods. $2.2 million is reflected in prepaid expenses on the consolidated balance sheet as of March 31, 2023. Turn Agreement On December 7, 2022, the Company acquired intellectual property rights pursuant to a Platform Intellectual Property License (the “Turn Agreement”) with Global Health Solutions, Inc. (d.b.a. Turn Therapeutics or “Turn”). The Turn Agreement provided MIMEDX with an exclusive, worldwide, sub-licensable license to use Turn’s proprietary antimicrobial technology platform (PermaFusion®) to develop antimicrobial product line extensions and new products. In addition, the Turn Agreement granted the Company the commercial rights to Turn’s placental collagen matrix product, FleX™ AM (“Flex”), contingent upon Turn’s receipt of FDA 510(k) clearance and other conditions. The Turn Agreement provided for a potential milestone payment by the Company of $9.6 million upon Turn’s receipt of 510(k) clearance for FleX. As of March 31, 2023, FleX has not received 510(k) clearance. Litigation and Regulatory Matters In the ordinary course of business, the Company and its subsidiaries may be a party to pending and threatened legal, regulatory, and governmental actions and proceedings (including those described below). In view of the inherent difficulty of predicting the outcome of such matters, particularly where the plaintiffs or claimants seek very large or indeterminate damages or where the matters present novel legal theories or involve a large number of parties, the Company generally cannot predict what the eventual outcome of the pending matters will be, what the timing of the ultimate resolution of these matters will be, or what the eventual recovery, loss, fines or penalties related to each pending matter may be. The Company's unaudited condensed consolidated balance sheet as of March 31, 2023 reflects the Company's current best estimate of probable losses associated with these matters, including costs to comply with various settlement agreements, where applicable. For more information regarding the Company’s legal proceedings, refer to Note 16, “Commitments and Contingencies” in the 2022 Form 10-K. The Company has not accrued for any potential losses related to legal matters as of March 31, 2023. The Company paid $0.2 million toward the resolution of legal matters involving the Company during the three months ended March 31, 2023. The following is a description of certain litigation and regulatory matters to which the Company is a party: Securities Class Action On January 16, 2019, the United States District Court for the Northern District of Georgia entered an order consolidating two purported securities class actions (MacPhee v. MiMedx Group, Inc., et al. filed February 23, 2018 and Kline v. MiMedx Group, Inc., et al. filed February 26, 2018). The order also appointed Carpenters Pension Fund of Illinois (“CPFI”) as lead plaintiff. On May 1, 2019, CPFI filed a consolidated amended complaint, naming as defendants the Company, Michael J. Senken, Parker H. “Pete” Petit, William C. Taylor, Christopher M. Cashman and Cherry Bekaert & Holland LLP. The amended complaint (the “Securities Class Action Complaint”) alleged violations of Section 10(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), Rule 10b-5 promulgated thereunder, and Section 20(a) of the Exchange Act. It asserted a class period of March 7, 2013 through June 29, 2018. Following the filing of motions to dismiss by the various defendants, CPFI was granted leave to file an amended complaint. CPFI filed its amended complaint against the Company, Michael J. Senken, Parker H. Petit, William C. Taylor, and Cherry Bekaert & Holland (Christopher Cashman was dropped as a defendant) on March 30, 2020. The defendants filed motions to dismiss on May 29, 2020. On March 25, 2021, the Court granted defendants’ respective motions to dismiss, finding that CPFI lacked standing to bring the underlying claims and also could not establish loss causation because it sold all of its shares in MIMEDX prior to any corrective disclosures, and dismissed the case. On April 22, 2021, CPFI filed a motion for reconsideration of the dismissal and for leave to amend to add a new plaintiff to attempt to cure the standing and loss causation issues. On January 28, 2022, the Court denied CPFI’s motion to reconsider and motion to substitute class representative. On February 25, 2022, CPFI filed a Notice of Appeal in the 11th Circuit Court of Appeals. Oral arguments were held on January 24, 2023. Welker v. MiMedx, et. al. On November 4, 2022, Troy Welker and Min Turner, former optionholders of the Company, brought a lawsuit in Fulton County State Court against the Company, former directors Terry Dewberry and Charles Evans, and former officers Parker H. “Pete” Petit, William C. Taylor, and Michael Senken alleging violations of the Georgia Racketeer Influenced and Corrupt Organizations (“RICO”) Act against all defendants, and conspiracy to violate the Georgia RICO Act and breach of fiduciary duty against the individual defendants. The Company is defending against the allegations and removed the case to the United States District Court for the Northern District of Georgia. Plaintiffs have filed a motion to remand back to state court, which is currently pending. Former Employee Litigation and Related Matters On January 12, 2021, the Company filed suit in the Circuit Court of the Eleventh Judicial District in and for Miami-Dade County, Florida (MiMedx Group, Inc. v. Petit, et. al.) against its former CEO, Parker H. “Pete” Petit, and its former COO, William C. Taylor, seeking a determination of its rights and obligations under indemnification agreements with Petit and Taylor following a federal jury’s guilty verdict against Petit for securities fraud and Taylor for conspiracy to commit securities fraud. The Company is seeking a declaratory judgment that it is not obligated to indemnify or advance expenses to Petit and Taylor in connection with certain cases to which Petit and Taylor are parties and also seeking to recoup amounts previously paid on behalf of Petit and Taylor in connection with such cases. On April 22, 2021, Petit and Taylor filed an answer and asserted counterclaims against the Company alleging breach of their indemnification agreements, breach of the covenant of good faith and fair dealing with respect to their indemnification agreements, and seeking a declaration that the Company remains obligated to indemnify and advance fees in connection with certain cases. Petit and Taylor simultaneously also filed a motion seeking to compel the Company to advance and reinstate its payments of Petit and Taylor’s legal expenses. The Company opposed Petit and Taylor’s motion and a hearing was set for June 23, 2021. At the joint request of the parties, the hearing was cancelled to allow the parties to attend a mediation to attempt a resolution of this matter; such mediation was held on August 11, 2021. Following the mediation, the Company and Mr. Taylor reached an agreement to settle the matter between them. Negotiations with Mr. Petit are ongoing. Other Matters Under the Florida Business Corporation Act and agreements with its current and former officers and directors, the Company is obligated to indemnify its current and former officers and directors who are made party to a proceeding, including a proceeding brought by or in the right of the corporation, with certain exceptions, and to advance expenses to defend such matters. The Company has already borne substantial costs to satisfy these indemnification and expense advance obligations and may continue to do so in the future. Costs incurred pursuant to these agreements are included in investigation, restatement and related expense in the unaudited condensed consolidated statements of operations. In addition to the matters described above, the Company is a party to a variety of other legal matters that arise in the ordinary course of the Company’s business, none of which are deemed to be individually material at this time. Due to the inherent uncertainty of litigation, there can be no assurance that the resolution of any particular claim or proceeding would not have a material adverse effect on the Company’s business, results of operations, financial position or liquidity.
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Revenue |
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Revenue | RevenueNet Sales by Product MIMEDX has two primary classes of products: (1) Advanced Wound Care, or Section 361, products, consisting of its tissue and cord sheet allograft products as well as certain particulate products regulated under Section 361, and (2) Section 351 products, consisting of the Company’s micronized and certain other particulate products. Advanced Wound Care is further disaggregated between the Company’s Tissue/Other and Cord products. Below is a summary of net sales by class of product (in thousands):
(1) Revenue recognized from collections relating to revenue transactions for which performance obligations were fulfilled prior to October 1, 2019, the date at which the Company changed its pattern of revenue recognition, for the three months ended March 31, 2022 of $0.1 million, which were separately presented in previously-issued financial statements, are presented as part of Section 351 in the table above. Net Sales by Site of Service MIMEDX has three sites of service for its products (1) Hospital settings and wound care clinics, which are stable reimbursement settings in which products are used for surgical applications, (2) Private offices, which generally represents doctors and practitioners with independent operations, and (3) Other, which includes federal facilities, international sales, and other sites of service. Below is a summary of net sales by site of service (in thousands):
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 months ended March 31, 2023 or 2022.
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Segment Information |
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Segment Reporting [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Segment Information | Segment Information The Company has two reportable segments: Wound & Surgical and Regenerative Medicine. See Note 13, Segment Information, included in the 2022 Form 10-K for descriptions of each reportable segment. The accounting policies of the segments are the same as the Company’s accounting policies. See Note 2, Significant Accounting Policies, included in the 2022 Form 10-K. The Company evaluates the performance of its segments and allocates resources based on segment contribution, defined as net sales less (i) cost of sales, (ii) selling, general and administrative expense, (iii) research and development expense, and (iv) amortization of intangible assets. Prior period results were recast on the basis of new operating segments. The only components which comprise loss before income tax provision that are not included in operating loss are interest expense, net and other expense, net. The Company does not allocate any assets to the reportable segments. No asset information is reported or disclosed to the chief operating decision maker in the financial information for each segment. Net sales and segment contribution by each reportable segment for the three months ended March 31, 2023 were as follows (in thousands):
Net sales and segment contribution by each reportable segment for the three months ended March 31, 2022 were as follows (in thousands):
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Significant Accounting Policies (Policies) |
3 Months Ended |
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Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments considered necessary for a fair presentation of the results of operations for the periods presented have been included. The operating results for the three months ended March 31, 2023 and 2022 are not necessarily indicative of the results that may be expected for the full fiscal year. The balance sheet as of December 31, 2022 was derived from the audited consolidated financial statements at that date, but does not include all of the information and footnotes required by GAAP for complete financial statements. These unaudited condensed consolidated financial statements should be read in conjunction with the historical consolidated financial statements of the Company included in the 2022 Form 10-K.
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Reclassifications | Reclassifications Increase in cash resulting from changes in income taxes of $0.1 million for the three months ended March 31, 2022, which was separately presented in the unaudited condensed consolidated statement of cash flows in previously-issued financial statements, is included as part of increases and decreases in cash resulting from changes in other assets in the unaudited condensed consolidated statement of cash flows included as part of these financial statements.
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Principles of Consolidation | Principles of Consolidation The consolidated financial statements include the accounts of MiMedx Group, Inc. and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated upon consolidation.
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Use of Estimates | Use of Estimates GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported consolidated statements of operations during the reporting period. Actual results could differ from those estimates. Significant estimates include estimated useful lives and potential impairment of property and equipment, estimates of impairment for goodwill and intangible assets, estimates of loss for contingent liabilities, estimate of allowance for doubtful accounts, management’s assessment of the Company’s ability to continue as a going concern, estimate of fair value and the probable achievement of share-based payments, estimates of returns and allowances, and valuation of deferred tax assets.
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Share-Based Compensation | Share-Based Compensation The Company grants share-based awards to employees and members of the Company’s Board of Directors (the “Board”). Awards to employees and the Board are generally made annually. Grants are issued outside of the annual cadence for certain new hires, promotions, and other events. The amount of expense to be recognized is determined by the fair value of the award using inputs available as of the grant date. The fair value of non-option share awards that are not subject to a market condition is the value of the common stock on the grant date. For non-option share awards that are subject to a market condition, the fair value of the common stock on the grant date is adjusted to reflect the value of the market condition, generally using a path-dependent pricing model, such as a Monte Carlo simulation. The fair value of stock option grants is estimated using an option pricing model, as appropriate based on the terms of the grant. Use of a valuation model requires management to make certain assumptions with respect to selected model inputs, which generally follows the inputs to a Black-Scholes option pricing model. Absent the availability of an option market with similar terms to the awarded options, the Company uses the historical volatility of daily price changes in its share price for a period equal to the contractual or expected term of the option, as applicable, subject to adjustment for price activity associated with certain events which are not expected to recur during the relevant term to infer an expectation of volatility. The expected term is derived based on the Company’s expectations for option exercise by the recipients. The Company uses U.S. Treasury yields with a maturity similar to the expected or contractual term, as applicable, as the basis for its risk-free interest rate assumption. The Company has never declared a dividend on its common stock and, therefore, assumes a dividend yield of 0%. For awards with service-based vesting conditions only, the Company recognizes share-based compensation expense on a straight-line basis through the vesting date of the last tranche of the award. For awards which vest based on more than a service condition, the Company recognizes share-based compensation expense using a graded-vesting method, treating each tranche as if it were a separately-granted award and recognizing expense through the vesting date of each individual tranche. In each scenario, the Company recognizes share-based compensation expense to the extent associated service and performance conditions are considered probable to occur. Determinations of probability are made during each reporting period and use available evidence considered relevant for the particular performance condition. The Company recognizes the cumulative effect of changes in the probability of occurrence in the period of re-evaluation. The probability and ultimate resolution of market conditions is not considered in expense recognition. Consequently, the Company could recognize expense for awards that do not ultimately vest.
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Basic and Diluted Net Loss Per Common Share | Basic and Diluted Net Loss Per Common Share Basic net loss per common share is calculated as net loss available to common stockholders divided by the weighted average common shares outstanding for the applicable period. Net loss available to common stockholders is calculated by adjusting net loss for periodic accumulated dividends on the Company’s Series B Convertible Preferred Stock (“Series B Preferred Stock”). This amount is divided by the weighted average common shares outstanding during the period. Weighted average common shares outstanding is calculated as shares of the Company outstanding adjusted for the portion of the period for which they are outstanding. Unvested non-option share awards are excluded from the calculation of weighted average common shares outstanding until they have vested. Unvested stock options are excluded from the calculation of weighted average common shares outstanding until they are exercised. Shares issuable pursuant to the Company’s Employee Stock Purchase Plan (“ESPP”) are included for the minimum number of shares issuable beginning at the point in time that all contingencies for share issuance are resolved. Diluted net loss per common share adjusts basic net loss per common share for convertible securities, options, equity incentive awards, and other share-based payment awards which have yet to vest and vest only on the satisfaction of a service condition. Equity incentive awards and options that are subject to a performance or market condition are included only if the performance or market condition would be satisfied if the end of the applicable period were the end of the performance period. In any case, these adjustments are reflected in the calculation of diluted net loss per common share to the extent that they reduce basic net loss per common share. The Company uses the if-converted method to calculate the dilutive effect of the Series B Preferred Stock and other convertible securities to the extent they are outstanding. The if-converted method assumes that convertible securities are converted at the later of the issuance date and the beginning of the period. If the hypothetical conversion of convertible securities, and the consequential avoidance of any accumulated preferred dividends, would decrease basic net loss per common share, these effects are incorporated in the calculation of diluted net loss per common share, adjusted for the portion of the period the securities were outstanding. The Company uses the treasury stock method to calculate the dilutive effect of options, non-option share awards, and certain other share-based payments. The treasury stock method assumes that the proceeds from exercise are used to repurchase common shares at the weighted average market price during the period, increasing the denominator for the net effect of shares issued upon exercise less hypothetical shares repurchased. Share-based payment awards which are subject to a performance or market condition are included if or to the extent that the applicable performance or market condition has been resolved as if the end of the applicable reporting period were the end of the applicable performance period. Shares issuable pursuant to the ESPP are included in the calculation of diluted net loss per common share to the extent that such shares would be issued based on the share price at the conclusion of the period, to the extent such shares are not already included in the calculation of weighted average common shares outstanding.
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Recently Issued Accounting Standards Not Yet Adopted | Recently Issued Accounting Standards Not Yet Adopted All ASUs issued and not yet effective for the three months ended March 31, 2023, and through the date of this report, were assessed and determined to be either not applicable or are expected to have minimal impact on the Company’s financial position and results of operations.
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Segment Reporting | The accounting policies of the segments are the same as the Company’s accounting policies. See Note 2, Significant Accounting Policies, included in the 2022 Form 10-K. The Company evaluates the performance of its segments and allocates resources based on segment contribution, defined as net sales less (i) cost of sales, (ii) selling, general and administrative expense, (iii) research and development expense, and (iv) amortization of intangible assets. Prior period results were recast on the basis of new operating segments. The only components which comprise loss before income tax provision that are not included in operating loss are interest expense, net and other expense, net. The Company does not allocate any assets to the reportable segments. No asset information is reported or disclosed to the chief operating decision maker in the financial information for each segment.
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Accounts Receivable, Net (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Receivables [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Accounts, Notes, Loans and Financing Receivable | Accounts receivable, net, consisted of the following (in thousands):
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Schedule of Activity Related to the Allowance for Doubtful Accounts | Activity related to the Company’s allowance for doubtful accounts for the three months ended March 31, 2023 was as follows (in thousands):
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Inventory (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Inventory | Inventory consisted of the following (in thousands):
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Property and Equipment, Net (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property, Plant and Equipment [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Property and Equipment | Property and equipment, net, consisted of the following (in thousands):
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Schedule of Depreciation Expense | Depreciation expense for the three months ended March 31, 2023 and 2022 is summarized in the table below (in thousands):
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Intangible Assets, Net (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Goodwill and Intangible Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Intangible Assets Activity Summary - Indefinite-lived | Intangible assets, net, are summarized as follows (in thousands):
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Schedule of Intangible Assets Activity Summary - Finite-lived | Amortization expense three months ended March 31, 2023 and 2022 is summarized in the table below (in thousands):
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Schedule of Estimated Future Amortization Expense for Intangible Assets | Expected future amortization of intangible assets as of March 31, 2023, is as follows (in thousands):
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Accrued Expenses (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Payables and Accruals [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Accrued Liabilities | Accrued expenses consisted of the following (in thousands):
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Long Term Debt, Net (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Debt | The balances of the Term Loan as of March 31, 2023 and December 31, 2022 were as follows (in thousands):
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Schedule of Interest Expense | Interest expense related to the Term Loan, included in interest expense, net in the unaudited condensed consolidated statements of operations, was as follows (amounts in thousands):
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Schedule of Future Principal Payments for the Term Loan | A summary of principal payments due on the Term Loan, by year, from March 31, 2023 through maturity are as follows (in thousands):
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Net Loss Per Common Share (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Basic Net Loss Per Common Share | The following table provides a reconciliation of net loss to net loss available to common stockholders and calculation of basic net loss per common share for each of the three months ended March 31, 2023 and 2022 (in thousands, except share and per share amounts):
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Diluted Net Loss Per Common Share | The following table sets forth the computation of diluted net loss per common share (in thousands, except share and per share amounts):
(a) Weighted average common shares outstanding for the calculation of diluted net loss per common share does not include the following adjustments for potential common shares below because their effects were determined to be antidilutive for the periods presented.
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Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share |
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Equity (Tables) |
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Mar. 31, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Equity [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Restricted Stock Awards by Award Type | The below table summarizes activity of unvested Equity Incentive Awards by award type from January 1, 2023 through March 31, 2023.
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Summary of Stock Options Activity | A summary of stock option activity for the three months ended March 31, 2023 is presented below:
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Schedule of Valuation Assumptions | The Company estimated the fair value of the awards using a Monte Carlo simulation using the following assumptions:
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Supplemental Disclosure of Cash Flow and Non-cash Investing and Financing Activities (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Supplemental Cash Flow Elements [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Supplemental Disclosure of Cash Flow and Non-cash Investing and Financing Activities | Selected cash payments, receipts, and non-cash activities are as follows (in thousands):
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Revenue (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue from Contract with Customer [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Disaggregation of Revenue | Below is a summary of net sales by class of product (in thousands):
(1) Revenue recognized from collections relating to revenue transactions for which performance obligations were fulfilled prior to October 1, 2019, the date at which the Company changed its pattern of revenue recognition, for the three months ended March 31, 2022 of $0.1 million, which were separately presented in previously-issued financial statements, are presented as part of Section 351 in the table above. Below is a summary of net sales by site of service (in thousands):
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Segment Information (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Segment Reporting [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Net Sales and Segment Contribution for Each Reportable Segment | Net sales and segment contribution by each reportable segment for the three months ended March 31, 2023 were as follows (in thousands):
Net sales and segment contribution by each reportable segment for the three months ended March 31, 2022 were as follows (in thousands):
|
Nature of Business (Details) |
3 Months Ended |
---|---|
Mar. 31, 2023
segment
| |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Number of reportable segments | 2 |
Significant Accounting Policies (Details) - USD ($) $ in Millions |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Dividends Payable [Line Items] | ||
Increase in cash resulting from changes in income tax | $ 0.1 | |
Stock Options | ||
Dividends Payable [Line Items] | ||
Expected dividend yield | 0.00% |
Accounts Receivable, Net - Accounts Receivable (Details) - USD ($) $ in Thousands |
Mar. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Receivables [Abstract] | ||
Accounts receivable, gross | $ 48,295 | $ 46,867 |
Less: allowance for doubtful accounts | (3,601) | (3,783) |
Accounts receivable, net | $ 44,694 | $ 43,084 |
Accounts Receivable, Net - Schedule of Activity Related to the Allowance for Doubtful Accounts (Details) - USD ($) |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Allowance for Doubtful Accounts | ||
Beginning balance | $ 3,783,000 | |
Bad debt expense | (60,000) | $ 0 |
Write-offs | (122,000) | |
Ending balance | $ 3,601,000 |
Accounts Receivable, Net - Narrative (Details) - USD ($) |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Receivables [Abstract] | ||
Bad debt expense | $ (60,000) | $ 0 |
Inventory (Details) - USD ($) $ in Thousands |
Mar. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Inventory Disclosure [Abstract] | ||
Raw materials | $ 896 | $ 810 |
Work in process | 6,087 | 6,855 |
Finished goods | 7,674 | 5,518 |
Inventory | $ 14,657 | $ 13,183 |
Property and Equipment, Net - Summary of Property and Equipment (Details) - USD ($) $ in Thousands |
Mar. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Property, Plant and Equipment [Line Items] | ||
Finance lease right-of-use asset | $ 189 | $ 189 |
Property and equipment, gross | 44,202 | 43,783 |
Less: accumulated depreciation and amortization | (36,640) | (35,927) |
Property and equipment, net | 7,562 | 7,856 |
Laboratory and clean room equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 16,955 | 16,422 |
Furniture and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 15,016 | 15,016 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 9,190 | 9,190 |
Construction in progress | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,889 | 1,983 |
Asset retirement cost | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 963 | $ 983 |
Property and Equipment, Net - Depreciation Expense (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 714 | $ 860 |
Intangible Assets, Net - Activity Summary (Details) - USD ($) $ in Thousands |
Mar. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | $ 10,963 | $ 10,923 |
Accumulated Amortization | (7,299) | (7,110) |
Net Carrying Amount | 3,664 | 3,813 |
Indefinite-lived Intangible Assets [Line Items] | ||
Intangible assets, gross carrying amount | 13,005 | 12,962 |
Intangible assets, net carrying amount | 5,706 | 5,852 |
Tradenames and trademarks | ||
Indefinite-lived Intangible Assets [Line Items] | ||
Gross carrying value, indefinite lived | 1,008 | 1,008 |
Patents in Process | ||
Indefinite-lived Intangible Assets [Line Items] | ||
Gross carrying value, indefinite lived | 1,034 | 1,031 |
Patents and know-how | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | 9,963 | 9,923 |
Accumulated Amortization | (7,282) | (7,106) |
Net Carrying Amount | 2,681 | 2,817 |
Licenses | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | 1,000 | 1,000 |
Accumulated Amortization | (17) | (4) |
Net Carrying Amount | $ 983 | $ 996 |
Intangible Assets, Net - Amortization Expense (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Amortization expense | $ 190 | $ 172 |
Intangible Assets, Net - Estimated Future Amortization Expense for Intangible Assets (Details) - USD ($) $ in Thousands |
Mar. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Estimated future amortization expense [Abstract] | ||
2023 (excluding the three months ended March 31, 2023) | $ 569 | |
2024 | 759 | |
2025 | 364 | |
2026 | 209 | |
2027 | 209 | |
Thereafter | 1,554 | |
Net Carrying Amount | $ 3,664 | $ 3,813 |
Accrued Expenses (Details) - USD ($) $ in Thousands |
Mar. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Payables and Accruals [Abstract] | ||
Legal and settlement costs | $ 6,302 | $ 4,447 |
Commissions to sales agents | 3,060 | 2,941 |
Accrued rebates | 874 | 707 |
Accrued group purchasing organization fees | 643 | 638 |
Estimated sales returns | 610 | 659 |
Accrued travel | 287 | 566 |
Accrued clinical trials | 90 | 90 |
Other | 1,175 | 976 |
Accrued expenses | $ 13,041 | $ 11,024 |
Long Term Debt, Net - Term Loan (Details) - Term loan - Hayfin Loan Agreement Term Loan - USD ($) |
Feb. 28, 2022 |
Mar. 31, 2023 |
Jul. 02, 2020 |
---|---|---|---|
Debt Instrument [Line Items] | |||
Principal issued | $ 50,000,000 | ||
Effective interest rate | 11.90% | ||
Fair value of the Term Loan | $ 48,100,000 | ||
London Interbank Offered Rate (LIBOR) | |||
Debt Instrument [Line Items] | |||
Debt instrument, interest rate, floor | 1.50% | ||
Debt instrument, basis spread on variable rate | 6.75% | ||
Minimum | Federal Funds Rate | |||
Debt Instrument [Line Items] | |||
Debt instrument, basis spread on variable rate | 0.50% | ||
Maximum | |||
Debt Instrument [Line Items] | |||
Interest rate | 2.50% |
Long Term Debt, Net - Term Loan Balances (Details) - USD ($) $ in Thousands |
Mar. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Debt Instrument [Line Items] | ||
Outstanding principal | $ 50,000 | |
Term loan | Hayfin Loan Agreement Term Loan | ||
Debt Instrument [Line Items] | ||
Outstanding principal | 50,000 | $ 50,000 |
Deferred financing costs | (1,114) | (1,219) |
Original issue discount | (172) | (187) |
Long term debt, net | $ 48,714 | $ 48,594 |
Long Term Debt, Net - Term Loan Interest Expense (Details) - Term loan - Hayfin Loan Agreement Term Loan - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Debt Instrument [Line Items] | ||
Stated interest | $ 1,436 | $ 1,031 |
Amortization of deferred financing costs | 105 | 97 |
Accretion of original issue discount | 16 | 15 |
Interest expense | $ 1,557 | $ 1,143 |
Long Term Debt, Net - Term Loan Maturity (Details) $ in Thousands |
Mar. 31, 2023
USD ($)
|
---|---|
Debt Disclosure [Abstract] | |
2023 (excluding the three months ended March 31, 2023) | $ 0 |
2024 | 0 |
2025 | 50,000 |
2026 | 0 |
2027 | 0 |
Thereafter | 0 |
Outstanding principal | $ 50,000 |
Net Loss Per Common Share - Basic Net Loss Per Common Share (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Earnings Per Share [Abstract] | ||
Net loss | $ (4,983) | $ (10,489) |
Accumulated dividends on Series B Preferred Stock | 1,684 | 1,586 |
Net loss available to common stockholders | $ (6,667) | $ (12,075) |
Weighted average common shares outstanding | 114,398,813 | 111,615,839 |
Basic net loss per common share (in dollars per share) | $ (0.06) | $ (0.11) |
Net Loss Per Common Share - Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Earnings Per Share [Abstract] | ||
Net loss available to common stockholders | $ (6,667) | $ (12,075) |
Accumulated dividends on Series B Convertible Preferred Stock | 1,684 | 1,586 |
Less: antidilutive adjustments | (1,684) | (1,586) |
Numerator | $ (6,667) | $ (12,075) |
Weighted average common shares outstanding | 114,398,813 | 111,615,839 |
Potential common shares | 30,151,138 | 29,459,846 |
Less: antidilutive potential common shares | (30,151,138) | (29,459,846) |
Weighted average shares outstanding adjusted for potential common shares | 114,398,813 | 111,615,839 |
Diluted net loss per common share (in dollars per share) | $ (0.06) | $ (0.11) |
Equity - Fair Value Assumptions (Details) - Stock option |
3 Months Ended |
---|---|
Mar. 31, 2023
$ / shares
| |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Dividend yield | 0.00% |
Executive Officer | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Stock price on grant date (in dollars per share) | $ 3.70 |
Exercise price (in dollars per share) | $ 3.70 |
Risk-free interest rate | 3.58% |
Expected volatility (annualized) | 75.00% |
Dividend yield | 0.00% |
Weighted average grant date fair value (in dollars per share) | $ 1.93 |
Income Taxes (Details) |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Income Tax Disclosure [Abstract] | ||
Effective tax rate | (1.00%) | (0.60%) |
Supplemental Disclosure of Cash Flow and Non-cash Investing and Financing Activities (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Supplemental Cash Flow Elements [Abstract] | ||
Cash paid for interest | $ 1,452 | $ 1,034 |
Cash paid for income taxes | 0 | 0 |
Non-cash activities: | ||
Purchases of equipment in accounts payable | 223 | 287 |
Issuance of shares pursuant to employee stock purchase plan | 680 | 0 |
Right of use assets arising from operating lease liabilities | $ 0 | $ (37) |
Commitments and Contingencies (Details) $ in Millions |
1 Months Ended | 3 Months Ended | |||
---|---|---|---|---|---|
Dec. 07, 2022
USD ($)
|
Jan. 16, 2019
class_action
|
Jun. 30, 2022
USD ($)
|
Mar. 31, 2023
USD ($)
|
Sep. 15, 2022
USD ($)
|
|
Loss Contingencies [Line Items] | |||||
Payments for legal settlements | $ 0.2 | ||||
Number of securities class actions | class_action | 2 | ||||
Turn Therapeutics | |||||
Loss Contingencies [Line Items] | |||||
Long-term purchase commitment amount | $ 9.6 | ||||
Research and Development Arrangement | Nordic Bioscience Clinical Development A/S | |||||
Loss Contingencies [Line Items] | |||||
Long-term purchase commitment amount | $ 10.2 | ||||
Payments made on long-term purchase commitment | 3.6 | ||||
Expenses on long-term purchase commitment | 0.6 | ||||
Remaining prepaid expenses on long-term purchase commitment | 2.2 | ||||
Chief Executive Officer | Separation Agreement | |||||
Loss Contingencies [Line Items] | |||||
Other commitment | 3.1 | $ 3.1 | |||
Other commitments paid | 0.9 | ||||
Other Commitment, Current | 1.6 | ||||
Other Commitment, Noncurrent | $ 0.6 |
Revenue - Summary of Revenue by Product Type (Details) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2023
USD ($)
product
|
Mar. 31, 2022
USD ($)
|
|
Revenue from Contract with Customer [Abstract] | ||
Number of products | product | 2 | |
Revenue, Major Customer [Line Items] | ||
Net sales | $ 71,676 | $ 58,894 |
Advanced Wound Care | ||
Revenue, Major Customer [Line Items] | ||
Net sales | 71,210 | 58,449 |
Tissue/Other | ||
Revenue, Major Customer [Line Items] | ||
Net sales | 65,771 | 52,852 |
Cord | ||
Revenue, Major Customer [Line Items] | ||
Net sales | 5,439 | 5,597 |
Section 351 | ||
Revenue, Major Customer [Line Items] | ||
Net sales | $ 466 | 445 |
Other | ||
Revenue, Major Customer [Line Items] | ||
Net sales | $ 100 |
Revenue - Summary of Revenue by Site Of Service (Details) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2023
USD ($)
service_site
|
Mar. 31, 2022
USD ($)
|
|
Revenue from Contract with Customer [Abstract] | ||
Number of sites of service | service_site | 3 | |
Revenue, Major Customer [Line Items] | ||
Net sales | $ 71,676 | $ 58,894 |
Hospital | ||
Revenue, Major Customer [Line Items] | ||
Net sales | 42,171 | 35,981 |
Private Office | ||
Revenue, Major Customer [Line Items] | ||
Net sales | 21,487 | 16,157 |
Other | ||
Revenue, Major Customer [Line Items] | ||
Net sales | $ 8,018 | $ 6,756 |
Segment Information - Narrative (Details) |
3 Months Ended |
---|---|
Mar. 31, 2023
segment
| |
Segment Reporting [Abstract] | |
Number of reportable segments | 2 |
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