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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
| | | | | |
☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the
Quarterly Period Ended
September 30, 2023
OR
| | | | | |
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from _____________________to______________________
Commission File Number 001-35887
MIMEDX GROUP, INC.
(Exact name of registrant as specified in its charter)
| | | | | | | | |
Florida | | 26-2792552 |
(State or other jurisdiction of incorporation or organization) | | (I.R.S. Employer Identification No.) |
| | | | | | | | |
1775 West Oak Commons Ct NE Marietta, GA | | 30062 |
(Address of principal executive offices) | | (Zip Code) |
(770) 651-9100
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
| | | | | | | | |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
Common Stock, par value $0.001 per share | MDXG | The Nasdaq Stock Market |
Securities registered pursuant to Section 12(g) of the Act: None.
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes x No ¨
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Yes x No ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| | | | | | | | | | | | | | |
Large accelerated filer ¨ | Accelerated filer x | 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. ¨ |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes ☐ No x
There were 116,376,583 shares of the registrant’s common stock, par value $0.001 per share, outstanding as of October 26, 2023.
Table of Contents
| | | | | | | | |
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 | | |
Explanatory Note and Important Cautionary Statement Regarding Forward-Looking Statements
As used herein, the terms “MIMEDX,” the “Company,” “we,” “our” and “us” refer to MiMedx Group, Inc., a Florida corporation, and its consolidated subsidiaries as a combined entity, except where it is clear that the terms mean only MiMedx Group, Inc.
Certain statements made in this Quarterly Report on Form 10-Q (this “Quarterly Report”) are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended. All statements relating to events or results that may occur in the future are forward-looking statements, including, without limitation, statements regarding the following:
•our strategic focus and current business priorities, and our ability to implement these priorities, including as a result of our no longer being able to market our micronized products and certain other products;
•our expectations regarding future revenue growth, margins, and cash flows;
•the advantages of our products and development of new products;
•our expectations regarding the size of potential markets for our products and any growth in such markets;
•our expectations regarding the regulatory pathway for our products;
•our expectations regarding ongoing regulatory obligations and oversight and the changing nature thereof impacting our products, research and clinical programs, and business, including those relating to patient privacy;
•our expectations regarding costs relating to compliance with regulatory requirements, including those arising from maintaining current Good Tissue Practice compliance;
•the likelihood, timing, and scope of possible regulatory approval and commercial launch of new products;
•our expectations regarding government and other third-party coverage and reimbursement for our existing and new products;
•our belief in the sufficiency of our intellectual property rights in our technology;
•our expectations regarding our ability to procure sufficient supplies of human tissue to manufacture and process our products;
•our expectations regarding our ability to fund our ongoing operations and future operating costs and the sufficiency of our liquidity and existing capital resources to implement our current business priorities;
•our expectations regarding future income tax liability;
•our expectations regarding the outcome of pending litigation and investigations;
•demographic and market trends; and
•our ability to compete effectively.
Forward-looking statements generally can be identified by words such as “expect,” “will,” “change,” “intend,” “seek,” “target,” “future,” “plan,” “continue,” “potential,” “possible,” “could,” “estimate,” “may,” “anticipate,” “to be” and similar expressions. These statements are based on numerous assumptions and involve known and unknown risks, uncertainties and other factors that could significantly affect the Company’s operations and may cause the Company’s actual actions, results, financial condition, performance or achievements to differ materially from any future actions, results, financial condition, performance or achievements expressed or implied by any such forward-looking statements. Factors that may cause such a difference include, without limitation, those discussed under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022 (our “2022 Form 10-K”), filed with the Securities and Exchange Commission (“SEC”) on February 28, 2023 and those discussed in Part II, Item 1A, Risk Factors, if any.
Unless required by law, the Company does not intend, and undertakes no obligation, to update or publicly release any revision to any forward-looking statements, whether as a result of the receipt of new information, the occurrence of subsequent events, a change in circumstances or otherwise. Each forward-looking statement contained in this Quarterly Report is specifically qualified in its entirety by the aforementioned factors. Readers are advised to carefully read this Quarterly Report in conjunction
with the important disclaimers set forth above prior to reaching any conclusions or making any investment decisions and not to place undue reliance on forward-looking statements, which speak only as of the date of the filing of this Quarterly Report with the SEC.
Estimates and Projections
This Quarterly Report includes certain estimates, projections and other statistical data. These estimates and projections reflect management’s best estimates based upon currently available information and certain assumptions we believe to be reasonable as of the date of this Quarterly Report. These estimates are inherently uncertain, subject to risks and uncertainties, many of which are not within our control, have not been reviewed by our independent auditors and may be revised as a result of management’s further review. In addition, these estimates and projections are not a comprehensive statement of our financial results, and our actual results may differ materially from these estimates and projections due to developments that may arise between now and the time the results are final. There can be no assurance that the estimates will be realized, and our results may vary significantly from the estimates, including as a result of unexpected issues in our business and operations. Accordingly, you should not place undue reliance on such information. Projections, assumptions and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk.
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
MIMEDX GROUP, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share data)
(unaudited)
| | | | | | | | | | | |
| September 30, 2023 | | December 31, 2022 |
ASSETS | | | |
Current assets: | | | |
Cash | $ | 81,164 | | | $ | 65,950 | |
Accounts receivable, net | 49,005 | | | 43,084 | |
Inventory | 19,068 | | | 13,183 | |
Prepaid expenses | 2,954 | | | 8,646 | |
| | | |
Other current assets | 2,311 | | | 3,335 | |
Total current assets | 154,502 | | | 134,198 | |
| | | |
Property and equipment, net | 7,094 | | | 7,856 | |
Right of use asset | 2,441 | | | 3,400 | |
Goodwill | 19,441 | | | 19,976 | |
Intangible assets, net | 5,395 | | | 5,852 | |
| | | |
Other assets | 149 | | | 148 | |
Total assets | $ | 189,022 | | | $ | 171,430 | |
LIABILITIES, CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS’ EQUITY (DEFICIT) | | | |
Current liabilities: | | | |
Accounts payable | $ | 9,170 | | | $ | 8,847 | |
Accrued compensation | 23,159 | | | 21,852 | |
Accrued expenses | 9,444 | | | 11,024 | |
| | | |
| | | |
| | | |
| | | |
Other current liabilities | 1,854 | | | 1,834 | |
Total current liabilities | 43,627 | | | 43,557 | |
Long term debt, net | 48,966 | | | 48,594 | |
Other liabilities | 2,605 | | | 4,773 | |
Total liabilities | $ | 95,198 | | | $ | 96,924 | |
Commitments and contingencies (Note 13) | | | |
Convertible preferred stock Series B; $0.001 par value; 100,000 shares authorized, issued and outstanding at September 30, 2023 and December 31, 2022 | $ | 92,494 | | | $ | 92,494 | |
Stockholders' equity (deficit) | | | |
Preferred stock Series A; $0.001 par value; 5,000,000 shares authorized, 0 issued and outstanding at September 30, 2023 and December 31, 2022 | $ | — | | | $ | — | |
Common stock; $0.001 par value; 250,000,000 shares authorized, 116,359,748 issued and outstanding at September 30, 2023 and 187,500,000 shares authorized, 113,705,447 issued and outstanding at December 31, 2022 | 116 | | | 114 | |
Additional paid-in capital | 188,369 | | | 173,804 | |
| | | |
Accumulated deficit | (187,155) | | | (191,906) | |
Total stockholders' equity (deficit) | 1,330 | | | (17,988) | |
Total liabilities, convertible preferred stock, and stockholders’ equity (deficit) | $ | 189,022 | | | $ | 171,430 | |
See notes to unaudited condensed consolidated financial statements
MIMEDX GROUP, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
(unaudited)
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
| | | | | | | |
Net sales | $ | 81,712 | | | $ | 67,689 | | | $ | 234,645 | | | $ | 193,466 | |
Cost of sales | 14,790 | | | 12,188 | | | 40,792 | | | 33,947 | |
Gross profit | 66,922 | | | 55,501 | | | 193,853 | | | 159,519 | |
| | | | | | | |
Operating expenses: | | | | | | | |
| | | | | | | |
| | | | | | | |
Selling, general and administrative | 52,571 | | | 53,475 | | | 156,773 | | | 158,838 |
Research and development | 3,175 | | | 5,953 | | | 18,168 | | | 17,429 | |
Restructuring (Note 16) | 208 | | | — | | | 3,464 | | | — | |
Investigation, restatement and related | (38) | | | 3,001 | | | 4,652 | | | 8,771 | |
| | | | | | | |
Amortization of intangible assets | 190 | | | 175 | | | 570 | | | 519 | |
Operating income (loss) | 10,816 | | | (7,103) | | | 10,226 | | | (26,038) | |
| | | | | | | |
Other expense, net | | | | | | | |
| | | | | | | |
Interest expense, net | (1,680) | | | (1,270) | | | (4,864) | | | (3,566) | |
Other expense, net | (11) | | | — | | | (42) | | | (1) | |
Income (loss) before income tax provision | 9,125 | | | (8,373) | | | 5,320 | | | (29,605) | |
Income tax provision expense | (591) | | | (53) | | | (569) | | | (178) | |
Net income (loss) | $ | 8,534 | | | $ | (8,426) | | | $ | 4,751 | | | $ | (29,783) | |
| | | | | | | |
Net income (loss) available to common shareholders (Note 9) | $ | 6,761 | | | $ | (10,096) | | | $ | (433) | | | $ | (34,667) | |
| | | | | | | |
| | | | | | | |
Net income (loss) per common share - basic | $ | 0.06 | | | $ | (0.09) | | | $ | (0.00) | | | $ | (0.31) | |
Net income (loss) per common share - diluted | $ | 0.06 | | | $ | (0.09) | | | $ | (0.00) | | | $ | (0.31) | |
| | | | | | | |
Weighted average common shares outstanding - basic | 116,298,146 | | | 113,448,251 | | | 115,528,067 | | 112,650,713 |
Weighted average common shares outstanding - diluted | 119,327,709 | | | 113,448,251 | | | 115,528,067 | | 112,650,713 |
See notes to unaudited condensed consolidated financial statements
MIMEDX GROUP, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ (DEFICIT) EQUITY
(in thousands, except share data)
(unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Common Stock Issued | | Additional Paid-In | | Treasury Stock | | Accumulated | | |
| Shares | | Amount | | Capital | | Shares | | Amount | | Deficit | | Total |
Balance at June 30, 2023 | 116,109,125 | | | $ | 116 | | | $ | 182,907 | | | — | | | $ | — | | | $ | (195,689) | | | $ | (12,666) | |
| | | | | | | | | | | | | |
Share-based compensation expense | — | | | — | | | 4,388 | | | — | | | — | | | — | | | 4,388 | |
Exercise of stock options | 41,233 | | | — | | | 274 | | | (17,032) | | 112 | | — | | | 386 | |
Employee stock purchase plan | 209,390 | | | — | | | 688 | | | — | | | — | | | — | | | 688 | |
Issuance of restricted stock | — | | | — | | | (73) | | | (11,080) | | | 73 | | | — | | | — | |
Restricted stock shares canceled/forfeited | — | | | — | | | 185 | | | 28,112 | | | (185) | | | — | | | — | |
| | | | | | | | | | | | | |
Net income | — | | | — | | | — | | | — | | | — | | | 8,534 | | | 8,534 | |
Balance at September 30, 2023 | 116,359,748 | | | $ | 116 | | | $ | 188,369 | | | — | | | $ | — | | | $ | (187,155) | | | $ | 1,330 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Common Stock Issued | | Additional Paid-In | | Treasury Stock | | Accumulated | | |
| Shares | | Amount | | Capital | | Shares | | Amount | | Deficit | | Total |
Balance at June 30, 2022 | 113,609,274 | | | $ | 114 | | | $ | 169,352 | | | 1,003 | | | $ | (3) | | | $ | (183,066) | | | $ | (13,603) | |
| | | | | | | | | | | | | |
Share-based compensation expense | — | | | — | | | 2,372 | | | — | | | — | | | — | | | 2,372 | |
Exercise of stock options | 49,666 | | | — | | | 132 | | | (1,001) | | | 5 | | | — | | | 137 | |
Issuance of restricted stock | 11,077 | | | — | | | — | | | — | | | — | | | — | | | — | |
Restricted stock shares canceled/forfeited | — | | | — | | | 9 | | | 1,836 | | | (9) | | | — | | | — | |
Net loss | — | | | — | | | — | | | — | | | — | | | (8,426) | | | (8,426) | |
Balance at September 30, 2022 | 113,670,017 | | | $ | 114 | | | $ | 171,865 | | | 1,838 | | | $ | (7) | | | $ | (191,492) | | | $ | (19,520) | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Common Stock Issued | | Additional Paid-In | | Treasury Stock | | Accumulated | | |
| Shares | | Amount | | Capital | | Shares | | Amount | | Deficit | | Total |
Balance at December 31, 2022 | 113,705,447 | | | $ | 114 | | | $ | 173,804 | | | — | | | $ | — | | | $ | (191,906) | | | $ | (17,988) | |
| | | | | | | | | | | | | |
Share-based compensation | — | | | — | | | 12,793 | | | — | | | — | | | — | | | 12,793 | |
Employee stock purchase plan | 444,809 | | | — | | | 1,368 | | | — | | | — | | | — | | | 1,368 | |
Issuance of restricted stock | 2,163,925 | | | 2 | | | (268) | | | (73,335) | | | 266 | | | — | | | — | |
Restricted stock shares canceled/forfeited | — | | | — | | | 378 | | | 90,367 | | | (378) | | | — | | | — | |
Exercise of stock options | 45,567 | | | — | | | 294 | | | (17,032) | | | 112 | | | — | | | 406 | |
| | | | | | | | | | | | | |
Net income | — | | | — | | | — | | | — | | | — | | | 4,751 | | | 4,751 | |
Balance at September 30, 2023 | 116,359,748 | | | $ | 116 | | | $ | 188,369 | | | — | | | $ | — | | | $ | (187,155) | | | $ | 1,330 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Common Stock Issued | | Additional Paid-In | | Treasury Stock | | Accumulated | | |
| Shares | | Amount | | Capital | | Shares | | Amount | | Deficit | | Total |
Balance at December 31, 2021 | 112,703,926 | | | $ | 113 | | | $ | 165,695 | | | 778,710 | | | $ | (4,017) | | | $ | (161,709) | | | $ | 82 | |
| | | | | | | | | | | | | |
Share-based compensation expense | — | | | — | | | 10,798 | | | — | | | — | | | — | | | 10,798 | |
Exercise of stock options | 133,762 | | | — | | | (697) | | | (151,239) | | | 1,271 | | | — | | | 574 | |
Issuance of restricted stock | 832,329 | | | 1 | | | (3,960) | | | (880,749) | | | 3,959 | | | — | | | — | |
Restricted stock shares canceled/forfeited | — | | | — | | | 29 | | | 5,338 | | | (29) | | | — | | | — | |
Shares repurchased for tax withholding | — | | | — | | | — | | | 249,778 | | | (1,191) | | | — | | | (1,191) | |
Net loss | — | | | — | | | — | | | — | | | — | | | (29,783) | | | (29,783) | |
Balance at September 30, 2022 | 113,670,017 | | | $ | 114 | | | $ | 171,865 | | | 1,838 | | | $ | (7) | | | $ | (191,492) | | | $ | (19,520) | |
See notes to unaudited condensed consolidated financial statements
MIMEDX GROUP, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited) | | | | | | | | | | | |
| Nine Months Ended September 30, |
| 2023 | | 2022 |
Cash flows from operating activities: | | | |
Net income (loss) | $ | 4,751 | | | $ | (29,783) | |
Adjustments to reconcile net income (loss) to net cash flows provided by (used in) operating activities: | | | |
Share-based compensation | 12,793 | | | 10,798 | |
Impairment of clinical trial assets | 1,974 | | | — | |
Depreciation | 2,054 | | | 2,549 | |
Non-cash lease expenses | 959 | | | 931 | |
Bad debt expense | 737 | | | 2,817 | |
Amortization of intangible assets | 570 | | | 519 | |
Impairment of goodwill | 535 | | | — | |
Amortization of deferred financing costs | 373 | | | 348 | |
Accretion of asset retirement obligation | 70 | | | 69 | |
Gain on fixed asset disposal | — | | | (17) | |
| | | |
Increase (decrease) in cash resulting from changes in: | | | |
Accounts receivable | (6,659) | | | (3,295) | |
Inventory | (5,885) | | | (2,586) | |
Prepaid expenses | 3,718 | | | 1,467 | |
| | | |
Other assets | 1,024 | | | (287) | |
Accounts payable | 323 | | | 1,090 | |
Accrued compensation | 1,511 | | | 495 | |
Accrued expenses | (1,289) | | | 1,711 | |
Other liabilities | (1,041) | | | 905 | |
Net cash flows provided by (used in) operating activities | 16,518 | | | (12,269) | |
| | | |
Cash flows from investing activities: | | | |
Purchases of equipment | (1,560) | | | (847) | |
Patent application costs | (114) | | | (128) | |
| | | |
Proceeds from sale of equipment | — | | | 24 | |
Net cash flows used in investing activities | (1,674) | | | (951) | |
| | | |
Cash flows from financing activities: | | | |
Proceeds from exercise of stock options | 406 | | | 574 | |
Principal payments on finance lease | (36) | | | (29) | |
Stock repurchased for tax withholdings on vesting of restricted stock | — | | | (1,191) | |
| | | |
| | | |
Net cash flows provided by (used in) financing activities | 370 | | | (646) | |
| | | |
Net change in cash | 15,214 | | | (13,866) | |
| | | |
Cash and cash equivalents, beginning of period | 65,950 | | | 87,083 | |
Cash and cash equivalents, end of period | $ | 81,164 | | | $ | 73,217 | |
See notes to unaudited condensed consolidated financial statements
MIMEDX GROUP, INC.
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2023 AND 2022
1.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 delivering innovative solutions to patients and the healthcare professionals who treat them. 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.
During the three and nine months ended September 30, 2023, the Company operated as two defined, internal business units: Wound & Surgical and Regenerative Medicine. On June 20, 2023, the Company announced that it would disband its Regenerative Medicine business unit and suspended its associated Knee Osteoarthritis clinical trial program. All activities in Regenerative Medicine during the three months ended September 30, 2023 were part of the wind-down of the unit, primarily related to regulatory obligations associated with its clinical trial, and it is expected that these activities will materially conclude during the fourth quarter of 2023.
2.Significant Accounting Policies
Please 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
These 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 and nine months ended September 30, 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.
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 infers an expectation for volatility using 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. 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%.
Expense is recognized over the requisite service period to achieve a vesting condition associated with an award, which can either be explicitly defined by the award, implied by its terms, or derived from potential market movements. In situations where multiple vesting conditions must be achieved, the longest service period is used as a basis for expense recognition. Derived service periods associated with market conditions are accelerated if such market conditions are met prior to the initially-assessed derived service period, but are not deferred if the market conditions are not met prior to the end of the initially-assessed derived service period.
For awards with only service-based vesting conditions, 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 service conditions, 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 that the associated service and performance conditions are considered probable to occur. Determinations of probability are made each reporting period and the Company uses available evidence considered relevant for evaluating the performance conditions. The Company recognizes the cumulative effect of changes in the probability of occurrence in the period of re-evaluation. The probability of occurrence and ultimate resolution of a market condition is not considered in expense recognition. Consequently, the Company could recognize expense for awards that do not ultimately vest.
Basic and Diluted Net Income (Loss) Per Common Share
Basic net income (loss) per common share is calculated as net income (loss) available to common stockholders divided by weighted average common shares outstanding for the applicable period. Net income (loss) available to common stockholders is calculated by adjusting net income (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. Unexercised 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 income (loss) per common share adjusts basic net income (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 income (loss) per common share to the extent that they reduce basic net income (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 income (loss) per common share,
these effects are incorporated in the calculation of diluted net income (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.
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 Adopted Accounting Pronouncements
In March 2020, the Financial Accounting Standards Board issued Accounting Standards Update (“ASU”) 2020-04, “Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting.” ASU 2020-04 provides temporary expedients to accounting guidance for certain contract modifications and hedging arrangements to ease financial reporting burdens as a result of market transitions from certain reference rates, including the London Interbank Offered Rate (“LIBOR”). The updates are effective immediately and may be applied prospectively to contract modifications made and hedging relationships entered into or evaluated on or before December 31, 2024.
In June 2023, the Company entered into Amendment No. 2 (the “Second Amendment”) to the loan agreement, dated as of June 30, 2020, by and among the Company, Hayfin Services, LLP (“Hayfin”), an affiliate of Hayfin Capital Management LLP, and certain other parties, (as amended, the “Hayfin Loan Agreement”), pursuant to which the reference rate used to determine the interest rate was changed from the London Interbank Offered Rate (“LIBOR”) to the Secured Overnight Financing Rate (“SOFR”). Because the only terms of the Second Amendment that affected the Company’s contractual cash flows were related to the changes in the reference rate, the Company adopted the optional guidance prescribed by Topic 848 to this transaction. The adoption of ASU 2020-04 and its application to the Second Amendment did not materially impact the Company’s unaudited condensed consolidated financial statements as of or for the three or nine months ended September 30, 2023.
Recently Issued Accounting Pronouncements Not Yet Adopted
All ASUs issued and not yet effective for the three and nine months ended September 30, 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.
3. Accounts Receivable, Net
Accounts receivable, net, consisted of the following (in thousands):
| | | | | | | | | | | |
| September 30, 2023 | | December 31, 2022 |
Accounts receivable, gross | $ | 51,579 | | | $ | 46,867 | |
Less: allowance for doubtful accounts | (2,574) | | | (3,783) | |
Accounts receivable, net | $ | 49,005 | | | $ | 43,084 | |
Activity related to the Company’s allowance for doubtful accounts for the three months ended September 30, 2023 and 2022 were as follows (in thousands):
| | | | | | | | | | | |
| 2023 | | 2022 |
Balance at July 1 | $ | 2,196 | | | $ | 3,471 | |
Bad debt expense | 447 | | | 426 | |
Write-offs | (69) | | | (67) | |
Balance at September 30 | $ | 2,574 | | | $ | 3,830 | |
Activity related to the Company’s allowance for doubtful accounts for the nine months ended September 30, 2023 and 2022 were as follows (in thousands):
| | | | | | | | | | | |
| 2023 | | 2022 |
Balance at January 1 | $ | 3,783 | | | $ | 1,187 | |
Bad debt expense | 737 | | | 2,817 | |
Write-offs | (1,946) | | | (174) | |
Balance at September 30 | $ | 2,574 | | | $ | 3,830 | |
4. Inventory
Inventory consisted of the following (in thousands): | | | | | | | | | | | |
| September 30, 2023 | | December 31, 2022 |
Raw materials | $ | 838 | | | $ | 810 | |
Work in process | 10,547 | | | 6,855 | |
Finished goods | 7,683 | | | 5,518 | |
| | | |
| | | |
Inventory | $ | 19,068 | | | $ | 13,183 | |
5. Property and Equipment, Net
Property and equipment, net, consisted of the following (in thousands):
| | | | | | | | | | | |
| September 30, 2023 | | December 31, 2022 |
Laboratory and clean room equipment | $ | 17,551 | | | $ | 16,422 | |
Furniture and equipment | 15,255 | | | 15,016 | |
Leasehold improvements | 9,418 | | | 9,190 | |
Construction in progress | 1,656 | | | 1,983 | |
Asset retirement cost | 960 | | | 983 | |
Finance lease right-of-use asset | 189 | | | 189 | |
Property and equipment, gross | 45,029 | | | 43,783 | |
Less: accumulated depreciation and amortization | (37,935) | | | (35,927) | |
Property and equipment, net | $ | 7,094 | | | $ | 7,856 | |
Depreciation expense for the three and nine months ended September 30, 2023 and 2022 is summarized in the table below (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
Depreciation expense | $ | 653 | | | $ | 831 | | | $ | 2,054 | | | $ | 2,549 | |
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.
6. Goodwill and Intangible Assets, Net
Goodwill
The following table provides a summary of goodwill activity for the nine months ended September 30, 2023 (in thousands):
| | | | | | | | | | | | | | | | | |
| Wound & Surgical | Regenerative Medicine | | Goodwill |
Balance as of December 31, 2022 | $ | 19,441 | | | $ | 535 | | | $ | 19,976 | |
Impairment of goodwill | — | | | (535) | | | (535) | |
Balance as of September 30, 2023 | $ | 19,441 | | | $ | — | | | $ | 19,441 | |
There was no goodwill activity during the three months ended September 30, 2023 or during the three or nine months ended September 30, 2022.
Impairment of Regenerative Medicine Business Unit
On June 20, 2023, the Company announced the disbanding of its Regenerative Medicine business unit and the suspension of its Knee Osteoarthritis clinical trial program. As a result of this event, the Company evaluated goodwill associated with the Regenerative Medicine reporting unit for potential impairment. The Company estimated fair value for the reporting unit using the income approach; specifically, a discounted cash flow method. As a result of this assessment, management concluded that the carrying value of the reporting unit exceeded its carrying value by an amount that exceeded its goodwill balance. Accordingly, the Company recognized an impairment loss for the full amount of the goodwill ascribed to the Regenerative Medicine reporting unit. The impairment loss is included as a component of restructuring expense in the unaudited condensed statement of operations for the nine months ended September 30, 2023.
Intangible Assets, Net
Intangible assets, net, are summarized as follows (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| September 30, 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 | $ | 9,969 | | $ | (7,638) | | $ | 2,331 | | | $ | 9,923 | | $ | (7,106) | | $ | 2,817 | |
Licenses | 1,000 | | (42) | | 958 | | | 1,000 | | (4) | | $ | 996 | |
| | | | | | | |
| | | | | | | |
Total amortized intangible assets | $ | 10,969 | | $ | (7,680) | | $ | 3,289 | | | $ | 10,923 | | $ | (7,110) | | $ | 3,813 | |
| | | | | | | |
Unamortized intangible assets: | | | | | | | |
Tradenames and trademarks | $ | 1,008 | | | $ | 1,008 | | | $ | 1,008 | | | $ | 1,008 | |
Patents in Process | 1,098 | | | 1,098 | | | 1,031 | | | 1,031 | |
Total intangible assets | $ | 13,075 | | | $ | 5,395 | | | $ | 12,962 | | | $ | 5,852 | |
Expected future amortization of intangible assets as of September 30, 2023, is as follows (in thousands):
| | | | | |
Year ending December 31, | Estimated Amortization Expense |
2023 (excluding the nine months ended September 30, 2023) | $ | 190 | |
2024 | 759 | |
2025 | 364 | |
2026 | 210 | |
2027 | 209 | |
Thereafter | 1,557 | |
Total amortized intangible assets | $ | 3,289 | |
7. Accrued Expenses
Accrued expenses consisted of the following (in thousands):
| | | | | | | | | | | |
| September 30, 2023 | | December 31, 2022 |
Commissions to sales agents | $ | 3,213 | | | $ | 2,941 | |
| | | |
Accrued rebates | 1,244 | | | 707 | |
Legal and settlement costs | 1,025 | | | 4,447 | |
Estimated sales returns | 910 | | | 659 | |
Accrued group purchasing organization fees | 713 | | | 638 | |
Accrued clinical trials | 694 | | | 90 | |
Accrued contract termination costs | 547 | | | — | |
Accrued travel | 259 | | | 566 | |
| | | |
Other | 839 | | | 976 | |
Accrued expenses | $ | 9,444 | | | $ | 11,024 | |
8. Long Term Debt, Net
Hayfin Loan Agreement
On June 30, 2020, the Company entered into the Hayfin Loan Agreement, which provided the Company with a $50 million senior secured term loan (the “Term Loan”). The Term Loan matures on June 30, 2025 (the “Maturity Date”). Interest on any borrowings is based on SOFR, plus a fallback provision of 0.15%, subject a floor of 1.5% (the “Floor”), plus a Margin of 6.75% (the “Margin”). The Term Loan carried an interest rate of 12.3% as of September 30, 2023.
As of September 30, 2023, the Company was in compliance with all applicable financial covenants under the Hayfin Loan Agreement.
The balances of the Term Loan as of September 30, 2023 and December 31, 2022 were as follows (in thousands):
| | | | | | | | | | | |
| September 30, 2023 | | December 31, 2022 |
Outstanding principal | $ | 50,000 | | | $ | 50,000 | |
Deferred financing costs | (896) | | | (1,219) | |
Original issue discount | (138) | | | (187) | |
Long term debt, net | $ | 48,966 | | | $ | 48,594 | |
Interest expense related to the Term Loan, included in interest expense, net in the unaudited condensed consolidated statements of operations, was as follows (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
Stated interest | $ | 1,554 | | | $ | 1,151 | | | $ | 4,498 | | | $ | 3,225 | |
Amortization of deferred financing costs | 111 | | | 103 | | | 323 | | | 302 | |
Accretion of original issue discount | 17 | | | 16 | | | 50 | | | 46 | |
Interest expense | $ | 1,682 | | | $ | 1,270 | | | $ | 4,871 | | | $ | 3,573 | |
A summary of principal payments due on the Term Loan, by year, from September 30, 2023 through maturity are as follows (in thousands):
| | | | | |
Year ending December 31, | Principal |
2023 (excluding the nine months ended September 30, 2023) | $ | — | |
2024 | — | |
2025 | 50,000 | |
2026 | — | |
2027 | — | |
Thereafter | — | |
Outstanding principal | $ | 50,000 | |
As of September 30, 2023, the fair value of the Term Loan was $47.7 million. This valuation was calculated based on a series of Level 2 and Level 3 inputs, including a discount rate based on the credit risk spread of debt instruments of similar risk character in reference to U.S. Treasury instruments with similar maturities, with an incremental risk premium for risk factors specific to the Company. Fair value was calculated by discounting the remaining cash flows associated with the Term Loan to September 30, 2023 using this discount rate.
9. Net Income (Loss) Per Common Share
Net income (loss) per common share is calculated using two methods: basic and diluted.
Basic Net Income (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 and nine months ended September 30, 2023 and 2022 (in thousands, except share and per share amounts):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
Net income (loss) | $ | 8,534 | | | $ | (8,426) | | | $ | 4,751 | | | $ | (29,783) | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
Accumulated dividends on Series B Preferred Stock | 1,773 | | | 1,670 | | | 5,184 | | | 4,884 | |
Net income (loss) available to common stockholders | $ | 6,761 | | | $ | (10,096) | | | $ | (433) | | | $ | (34,667) | |
Weighted average common shares outstanding | 116,298,146 | | | 113,448,251 | | | 115,528,067 | | | 112,650,713 | |
Basic net income (loss) per common share | $ | 0.06 | | | $ | (0.09) | | | $ | (0.00) | | | $ | (0.31) | |
Diluted Net Income (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):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
Net income (loss) available to common stockholders | $ | 6,761 | | | $ | (10,096) | | | $ | (433) | | | $ | (34,667) | |
Adjustments: | | | | | | | |
Accumulated dividends on Series B Convertible Preferred Stock | 1,773 | | | 1,670 | | | 5,184 | | | 4,884 | |
Less: antidilutive adjustments | (1,773) | | | (1,670) | | | (5,184) | | | (4,884) | |
Total adjustments | — | | | — | | | — | | | — | |
Numerator | $ | 6,761 | | | $ | (10,096) | | | $ | (433) | | | $ | (34,667) | |
Weighted average shares outstanding | 116,298,146 | | | 113,448,251 | | | 115,528,067 | | | 112,650,713 | |
Adjustments: | | | | | | | |
Potential common shares (a) | | | | | | | |
| | | | | | | |
Restricted stock unit awards | 1,845,832 | | | — | | | — | | | — | |
Outstanding stock options | 1,131,410 | | | — | | | — | | | — | |
Performance stock unit awards | 35,441 | | | — | | | — | | | — | |
Restricted stock awards | 15,767 | | | — | | | — | | | — | |
Employee stock purchase plan | 1,113 | | | — | | | — | | | — | |
Total adjustments | 3,029,563 | | | — | | | — | | | — | |
Weighted average shares outstanding adjusted for potential common shares | 119,327,709 | | | 113,448,251 | | | 115,528,067 | | | 112,650,713 | |
Diluted net income (loss) per common share | $ | 0.06 | | | $ | (0.09) | | | $ | (0.00) | | | $ | (0.31) | |
(a) Weighted average common shares outstanding for the calculation of diluted net income (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.
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
Series B Convertible Preferred Stock | 30,445,997 | | | 28,685,739 | | | 29,559,946 | | | 27,850,916 | |
Restricted stock unit awards | — | | | 474,355 | | | 1,219,776 | | | 574,507 | |
Performance stock unit awards | — | | | 59,996 | | | 13,425 | | | 40,141 | |
Employee stock purchase plan | — | | | 4,536 | | | 372 | | | 1,517 | |
Restricted stock awards | — | | | 22,327 | | | 23,733 | | | 293,778 | |
Outstanding stock options | — | | | 22,528 | | | 107,897 | | | 97,190 | |
Potential common shares | 30,445,997 | | | 29,269,481 | | | 30,925,149 | | | 28,858,049 | |
10. 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 September 30, 2023 were $19.0 million. As this amount has not been declared, the Company has not recorded this amount on its unaudited condensed consolidated balance sheet as of September 30, 2023.
Based on accumulated dividends as of September 30, 2023, the Series B Preferred Stock was convertible into an aggregate of 30,906,441 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”, together with RSAs and RSUs, collectively, the “Equity Incentive Awards”) to its employees. The following is summary information for Equity Incentive Awards for the nine months ended September 30, 2023.
As of September 30, 2023, there was $24.1 million of unrecognized share-based compensation expense related to the Equity Incentive Awards. This expense is expected to be recognized over a weighted-average period of 2.33 years, which approximates the remaining vesting period of these grants. The table below summarizes activity of unvested Equity Incentive Awards by award type from January 1, 2023 through September 30, 2023.
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 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 | 122,755 | | $ | 6.13 | | | 4,774,971 | | $ | 6.28 | | | 241,072 | | $ | 4.62 | | | | |
Granted | — | | — | | | 3,266,244 | | 4.65 | | | 3,851,427 | | 3.83 | | | | |
Vested | (13,624) | | 6.18 | | | (2,237,260) | | 6.20 | | | — | | — | | | | |
Forfeited | (90,367) | | 5.83 | | | (1,715,136) | | 5.45 | | | (365,227) | | 4.24 | | | | |
Unvested at September 30, 2023 | 18,764 | | $ | 7.55 | | | 4,088,819 | | $ | 5.38 | | | 3,727,272 | | $ | 3.84 | | | | |
Stock Options
A summary of stock option activity for the nine months ended September 30, 2023 is presented below:
| | | | | | | | | | | | | | | | | | | | | | | |
| Number of Shares | | Weighted- Average Exercise Price | | Weighted- Average Remaining Contractual Term (in years) | | Aggregate Intrinsic Value |
Outstanding at January 1, 2023 | 933,894 | | | $ | 6.46 | | | | | |
Granted | 3,694,000 | | | 3.77 | | | | | |
Exercised | (62,599) | | | 6.50 | | | | | |
| | | | | | | |
Vested options expired | (423,213) | | | 5.81 | | | | |
Outstanding at September 30, 2023 | 4,142,082 | | | 4.13 | | | 6.31 | | 13,178,214 | |
Exercisable at September 30, 2023 | 448,082 | | | $ | 7.06 | | | 0.60 | | $ | 174,314 | |
As of September 30, 2023, there was $5.5 million of unrecognized share-based compensation expense related to Stock Options. This expense is expected to be recognized over a weighted-average period of 2.22 years.
CEO Performance Grant
On January 27, 2023, the Company’s 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 occurrence based on that estimate. The Company recognized $0.4 million and $1.1 million of expense related to the CEO Performance PSUs during the three and nine months ended September 30, 2023, respectively.
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:
| | | | | |
| 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 | |
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 $0.7 million and $2.0 million of expense related to the CEO Performance Option during the three and nine months ended September 30, 2023, respectively.
CFO Inducement Grant
On July 5, 2023, the Company announced that Doug Rice was appointed to serve as Chief Financial Officer of the Company, effective that day. Mr. Rice’s compensation included, among other things, a grant of 162,000 PSUs, 97,200 RSUs, and 94,000 stock options (the “CFO Options”), as a material inducement to his hiring.
The PSUs vest based on a three-year performance period ending on December 31, 2025 based upon the achievement of specified performance conditions, subject to Mr. Rice’s continued employment, except in the case of Mr. Rice’s death or disability. The awards can vest between 50% and 150% of the original number of PSUs, depending on actual performance. Vesting is limited to 100% of the award in the event that certain share price conditions are not achieved. The total grant date fair value of the PSUs was $1.5 million.
The RSUs vest in three equal tranches on each of the first three anniversary dates of the grant date, provided Mr. Rice remains in continuous service with the Company. The total grant date fair value of the RSUs was $0.6 million.
The CFO Options vest in four equal tranches on each of the first four anniversary dates of the grant date, subject to Mr. Rice’s continued employment. The CFO Options expire on July 5, 2030. The total grant date fair value of the CFO Options was $0.4 million.
11. Income Taxes
The effective tax rates for the Company were 6.5% and (0.6)% for the three months ended September 30, 2023 and 2022, respectively. The effective tax rates for the Company were 10.7% and (0.6)% for the nine months ended September 30, 2023 and 2022, respectively. The effective tax rates for 2023 reflect the utilization of net operating losses and certain tax credits. The effective tax rates for 2022 reflect net operating losses offset by a valuation allowance.
12. 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):
| | | | | | | | | | | |
| Nine Months Ended September 30, |
| 2023 | | 2022 |
Cash paid for interest | $ | 4,496 | | | $ | 3,233 | |
Cash paid for income taxes | 210 | | | 184 | |
Non-cash activities: | | | |
Issuance of shares pursuant to employee stock purchase plan | 1,368 | | | — | |
Purchases of equipment in accounts payable | 126 | | | 353 | |
Right of use assets arising from operating lease liabilities | — | | | (37) | |
| | | |
| | | |
| | | |
| | | |
13. Commitments and Contingencies
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 was obligated to pay $10.2 million upon the achievement of specified milestones over the course of the clinical trial. In July 2023, the Company terminated the Nordic Agreement, in accordance with which the Company is obligated to reimburse NBCD for services performed through the effective termination date and for non-cancelable obligations reasonably incurred prior to that date. In addition, the Company and NBCD have certain regulatory obligations for all trial participants enrolled in the study prior to the suspension of clinical trial activities. Refer to Note 16, “Restructuring,” for additional discussion.
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 September 30, 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 September 30, 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 the Company 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. On July 10, 2023, the Court of Appeals affirmed the District Court’s dismissal of the case and the denial of the motion for leave to amend. On July 31, 2023, CPFI filed a petition for rehearing en banc, which was denied on September 6, 2023.
Welker v. MiMedx, et. al.
On November 4, 2022, Troy Welker and Min Turner, former option holders 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 filed a motion to remand back to state court, which was granted. The Company has filed its answer and a motion to dismiss, 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 previously borne substantial costs to satisfy these indemnification and expense advance obligations and may continue to incur such costs 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.
14. Revenue
Net Sales by Site of Service
The Company 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):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
Hospital | $ | 47,350 | | | $ | 40,174 | | | $ | 136,108 | | | $ | 116,081 | |
Private Office | 22,951 | | | 19,572 | | | 68,188 | | | 54,768 | |
Other | 11,411 | | | 7,943 | | | 30,349 | | | 22,617 | |
Total | $ | 81,712 | | | $ | 67,689 | | | $ | 234,645 | | | $ | 193,466 | |
| | | | | | | |
The Company did not have significant foreign operations or a single external customer from which 10% or more of revenues were derived during the three or nine months ended September 30, 2023 or 2022.
Net Sales by Product
The Company 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 subject to regulation under Section 361 of the Public Health Service Act and related regulations (“Section 361”), and (2) Section 351 products, consisting of the Company’s micronized and certain other particulate products subject to regulation under Section 351 of the Public Health Service Act and related regulations (“Section 351”). 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):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
Advanced Wound Care | | | | | | | |
Tissue/Other | $ | 75,570 | | | $ | 61,131 | | | $ | 216,825 | | | $ | 174,256 | |
Cord | 6,066 | | | 5,678 | | | 17,259 | | | 17,165 | |
Total Advanced Wound Care | 81,636 | | | 66,809 | | | 234,084 | | | 191,421 | |
Section 351(1) | 76 | | | 880 | | | 561 | | | 2,045 | |
Total | $ | 81,712 | | | $ | 67,689 | | | $ | 234,645 | | | $ | 193,466 | |
(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 and nine months ended September 30, 2022 of $0.1 million and $0.2 million, respectively, which were separately presented in previously-issued financial statements, are presented as part of Section 351 in the table above.
15. Segment Information
The Company had two reportable segments during the three and nine months ended September 30, 2023: Wound & Surgical and Regenerative Medicine.
•Wound & Surgical focused on the Advanced Wound Care and Surgical Recovery markets through the sale of the Company’s portfolio of products and product development to serve these primary end markets. Its platform technologies include tissue allografts derived from human placental membrane (EPIFIX®, AMNIOFIX®, and AMNIOEFFECT®), tissue allografts derived from human umbilical cord (EPICORD® and AMNIOCORD®), and a particulate extracellular matrix derived from human placental disc (AXIOFILL®). This segment is also responsible for international sales of the Company’s Section 351 products.
•Prior to June 20, 2023, Regenerative Medicine focused solely on Regenerative Medicine technologies, specifically progressing the Company’s placental biologics platform towards registration as an FDA-approved biological drug. On June 20, 2023, the Company announced a plan to disband the Regenerative Medicine business unit and suspended its Knee Osteoarthritis clinical trial program. The Company is actively managing wind-down activities for its Regenerative Medicine business unit, primarily related to regulatory obligations associated with its clinical trial. The Company expects that these activities will materially conclude in the fourth quarter of 2023.
The accounting policies of the segments were the same as the Company’s accounting policies. See Note 2, “Significant Accounting Policies,” included in the 2022 Form 10-K.
The Company evaluated the performance of its segments and allocated 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, (iv) amortization of intangible assets, and (v) restructuring. The only components which comprised income (loss) before income tax provision that were not included in operating income (loss) were interest expense, net and other expense, net.
The Company did not allocate any assets to the reportable segments. No asset information was 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 September 30, 2023 were as follows (in thousands):
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| Wound & Surgical | | Regenerative Medicine | | Corporate & Other | | Consolidated | |
Net sales | $ | 80,376 | | | $ | — | | | $ | 1,336 | | | $ | 81,712 | | |
Cost of sales | 13,305 | | | — | | | 1,485 | | | 14,790 | | |
Selling, general and administrative expense | 38,687 | | | — | | | 13,884 | | | 52,571 | | |
Research and development expense | 3,175 | | | — | | | — | | | 3,175 | | |
Restructuring | — | | | 208 | | | — | | | 208 | | |
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Amortization of intangible assets | — | | | — | | | 190 | | | 190 | | |
Segment contribution | $ | 25,209 | | | $ | (208) | | | | | | |
Investigation, restatement and related expense | | | | | | | (38) | | |
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Operating income | | | | | | | $ | 10,816 | | |
Supplemental information | | | | | | | | |
Depreciation expense | $ | 423 | | | $ | — | | | $ | 230 | | | $ | 653 | | |
Share-based compensation | $ | 1,902 | | | $ | — | | | $ | 2,486 | | | $ | 4,388 | | |
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Net sales and segment contribution by each reportable segment for the three months ended September 30, 2022 were as follows (in thousands):
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| Wound & Surgical | | Regenerative Medicine | | Corporate & Other | | Consolidated | |
Net sales | $ | 66,873 | | | $ | — | | | $ | 816 | | | $ | 67,689 | | |
Cost of sales | 11,159 | | | — | | | 1,029 | | | 12,188 | | |
Selling, general and administrative expense | 35,530 | | | — | | | 17,945 | | | 53,475 | | |
Research and development expense | 1,680 | | | 4,273 | | | — | | | 5,953 | | |
Amortization of intangible assets | — | | | — | | | 175 | | | 175 | | |
Segment contribution | $ | 18,504 | | | $ | (4,273) | | | | | | |
Investigation, restatement and related expense | | | | | | | 3,001 | | |
Operating loss | | | | | | | $ | (7,103) | | |
Supplemental information | | | | | | | | |
Depreciation expense | $ | 451 | | | $ | 36 | | | $ | 344 | | | $ | 831 | | |
Share-based compensation | $ | 1,945 | | | $ | 347 | | | $ | 80 | | | $ | 2,372 | | |
Net sales and segment contribution by each reportable segment for the nine months ended September 30, 2023 were as follows (in thousands):
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| Wound & Surgical | | Regenerative Medicine | | Corporate & Other | | Consolidated | |
Net sales | $ | 231,466 | | | $ | — | | | $ | 3,179 | | | $ | 234,645 | | |
Cost of sales | 37,373 | | | — | | | 3,419 | | | 40,792 | | |
Selling, general and administrative expense | 114,853 | | | — | | | 41,920 | | | 156,773 | | |
Research and development expense | 6,330 | | | 11,838 | | | — | | | 18,168 | | |
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Restructuring | — | | | 3,464 | | | — | | | 3,464 | | |
Amortization of intangible assets | — | | | — | | | 570 | | | 570 | | |
Segment contribution | $ | 72,910 | | | $ | (15,302) | | | | | | |
Investigation, restatement and related expense | | | | | | | 4,652 | | |
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Operating income | | | | | | | $ | 10,226 | | |
Supplemental information | | | | | | | | |
Depreciation expense | $ | 1,208 | | | $ | 135 | | | $ | 711 | | | $ | 2,054 | | |
Share-based compensation | $ | 5,130 | | | $ | 259 | | | $ | 7,404 | | | $ | 12,793 | | |
Net sales and segment contribution by each reportable segment for the nine months ended September 30, 2022 were as follows (in thousands):