Correspondence 0001193125-24-146852 from MIMEDX GROUP, INC. (MDXG) (CIK 0001376339) (MDXG)
MIMEDX GROUP, INC. (MDXG) (CIK 0001376339)
Date: May 24, 2024 · CIK: 0001376339 · Accession: 0001193125-24-146852
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File numbers found in text: 001-35887
Referenced dates: May 10, 2024
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CORRESP 1 filename1.htm CORRESP May 24, 2024 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance, Office of Industrial Applications and Services 100 F Street, NE Washington, DC 20549 Attention: Julie Sherman Michael Fay Re: MIMEDX GROUP, INC. Form 10-K for the Fiscal Year Ended December 31, 2023 Filed February 28, 2024 Form 10-Q for the Quarterly Period Ended March 31, 2024 Filed April 30, 2024 File No. 001-35887 Ladies and Gentlemen: This letter is submitted by MiMedx Group, Inc. (the “Company” or “MiMedx”) in response to your letter dated May 10, 2024, regarding the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 (the “Annual Report”) and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 (the “Quarterly Report”). For ease of reference, the text of the Staff’s comments is included in bold, italicized text below, followed in each case by the Company’s response. Capitalized items used herein, if not otherwise defined herein, refer to the definitions of such terms in the Annual Report or Quarterly Report, as applicable. Form 10-Q For the Quarterly Period Ended March 31, 2024 TELA and Regenity Agreements, page 17 1. You disclose the Company entered into an Asset Purchase Agreement with TELA to obtain exclusive rights to sell and market a 510(k)-cleared collagen particulate xenograft product in the United States pursuant to a pre-existing Manufacturing and Supply Agreement between TELA and Regenity, which retains all intellectual property rights and regulatory clearances related to the product. Simultaneously with entry into the TELA APA, the Company executed a new Manufacturing and Supply Agreement with Regenity, replacing the previous TELA-Regenity Supply Agreement. Please clarify for us, and in future filings as appropriate, your accounting and disclosure as it relates to the following: • Since you entered into a new supply agreement that replaced the pre-existing supply agreement, clarify why you do not consider the $7.6 million as a transaction cost to enter into the new agreement; The Company acknowledges the Staff’s comment and respectfully advises the Staff that, in evaluating the structure of the transaction, it should be noted that it was the Company’s belief that the acquisition of TELA’s exclusive rights to sell and market an FDA-approved, 510(k)-cleared, collagen particulate xenograft product (the “Xenograft Product”) pursuant to the original TELA-Regenity Supply Agreement was more economically beneficial than a potential multi-year investment towards developing its own, organic xenograft product. Currently, all of the Company’s products are derived from donated human placenta and umbilical cords; the Company does not currently have an animal-derived product as part of its portfolio. In addition, the regulatory pathways for xenograft products differ from those available to the Company’s existing placenta-based allograft products. Acquiring this right fulfilled a strategic priority for the Company, as noted by the Company’s CEO in a press release announcing the transaction, by diversifying the Company’s product offering beyond human-derived skin substitutes and by accelerating the addition of potential future xenograft products to the Company’s portfolio. The Company considered the appropriate accounting treatment for this transaction pursuant to Accounting Standards Codification (“ASC”) 805. While there were certain other immaterial assets acquired pursuant to the TELA Asset Purchase Agreement (the “TELA APA”), including small amounts of inventory, the Company concluded that substantially all of the fair value of the assets acquired was concentrated in an intangible asset consisting of the exclusive rights acquired from TELA under the TELA-Regenity Supply Agreement. Consequently, the acquisition did not meet the definition of a business, as prescribed by ASC 805-10-55-5A, and was accounted for instead as an acquisition of assets under ASC 805-50. In light of this treatment, because the consideration was paid to TELA in exchange for the exclusive rights, the consideration conveyed as part of the TELA APA was capitalized amongst the various assets acquired, pro rata, based on the relative fair value of the assets acquired. The TELA APA was executed by and between TELA and MiMedx alone. However, while negotiating the assignment of TELA’s rights under the TELA-Regenity Supply Agreement to MiMedx, MiMedx re-negotiated certain of the terms of that agreement with Regenity and executed a revised Supply Agreement immediately following the execution of the TELA APA. MiMedx would not have executed the TELA APA if there had been no assurance that Regenity would agree to the revised terms of the Supply Agreement with MiMedx. That said, no consideration was paid by MiMedx to Regenity to revise the original terms of the TELA-Regenity Supply Agreement; and because no consideration was paid to Regenity and no expenses were incurred related to the revisions to the Supply Agreement, the Company assigned all consideration transferred to TELA to the assets acquired (primarily the intangible asset consisting of the exclusive rights under the Supply Agreement) in accordance with ASC 805-50. • Clarify why you have not recorded the maximum profit share amount, how you will account for any future payments, and when you will record any future amounts due; The Profit Share Payments under the TELA APA can be bifurcated into two components: (1) the $3 million “Floor”, and (2) the $4 million potential Profit Share Payments over and above the Floor. The Profit Share Payments are payable quarterly for two years following the first quarter of MiMedx’s first sale of the Xenograft Product. Profit Share Payments for each quarter are based on MiMedx’s net sales of the Xenograft Product during that quarter. The Company evaluated each of these components against the GAAP definition of contingent consideration to determine the appropriate accounting treatment. Contingent consideration is defined as an obligation of the acquirer to transfer additional assets based on the resolution of specified future events. With respect to the Floor, the payment of $3 million is not contingent upon the resolution of future events as MiMedx has no practical ability to avoid the payment of $3 million to TELA. Consequently, this $3 million is reflected as a liability created on the transaction date, the fair value of which was calculated and added to the basis of the assets on the acquisition date. With respect to the remaining $4 million of potential Profit Share Payments, these payments will be made to TELA only to the extent that MiMedx generates sufficient sales of the Xenograft Product over the relevant period, as specified in the TELA APA. Because payment is contingent upon the occurrence of these sales, the Company concluded that this represents contingent consideration. ASC 805-50 does not provide explicit guidance on the accounting for contingent consideration arrangements for an asset acquisition. Therefore, the Company plans to capitalize the contingent consideration payments when the contingency is resolved and the actual costs are known (i.e. when such payments are due and payable), similar to previous guidance that existed in Financial Accounting Standards Board (“FASB”) Statement 141, Paragraph 27. Accordingly, the Company will reflect the liabilities incurred as these payments become due and payable with an associated increase in the value of the acquired assets. As of the acquisition date and the balance sheet date, these additional payments were not yet due and payable and, therefore, no liability has been recognized. • Clarify the term of the TELA APA and your methodology for amortizing the $7.6 million assigned cost; and MiMedx acquired rights under the TELA APA that were transferred to MiMedx immediately upon closing. While the term of the Company’s Supply Agreement with Regenity is through December 31, 2034, the Company is amortizing the $7.6 million of contract asset over a five-year period, reflecting the period over which it expects future cash flows to be generated by the asset. The Company intends to disclose this in future filings. • Clarify when you anticipate commercialization of the xenograft product to commence and whether you evaluated the recorded costs for recoverability before recording them as an asset. The Company plans to begin sales of its version of the Xenograft Product by the third quarter of 2024 given that TELA had previously sold its version of the Xenograft Product in the United States prior to the execution of the TELA APA. The remaining steps the Company is taking towards commercialization generally relate to product re-branding, including pricing, packaging and finalization of commercial strategy. The Company does not view these as being substantial hurdles prior to commercialization of the product (i.e., the technology is already commercially viable). As noted above, the Company assessed the fair value of all assets acquired pursuant to the TELA APA. With respect to the exclusive rights, the Company used a discounted cash flow approach. On an undiscounted basis, these cash flows were sufficient to substantiate the recorded asset as required by the recoverability test in ASC 360-10-35-17. In response to your comments, in future filings, the Company intends to enhance the previous disclosures in the footnotes to the consolidated financial statements regarding the acquisition of the exclusive distribution rights as follows: On March 15, 2024, the Company entered into an Asset Purchase Agreement (the “TELA APA”) with TELA Bio, Inc. (“TELA”) to obtain exclusive rights to sell and market a 510(k)-cleared collagen particulate xenograft product in the United States. TELA held these rights pursuant to a Manufacturing and Supply Agreement (the “TELA-Regenity Supply Agreement”) between TELA and Regenity Biosciences, Inc. (“Regenity”), which retains all intellectual property rights and regulatory clearances related to the product. Pursuant to the TELA APA, the Company paid $5.0 million of initial consideration to TELA; additionally, the Company paid $0.4 million to acquire TELA’s remaining product inventory, and will be required to make additional payments (the “Profit Share Payments”) of between a minimum of $3.0 million and a maximum of $7.0 million based on MIMEDX’s net sales of the product over the two years following its commercialization of the product, which is expected to begin by the third quarter of 2024. In connection with the execution of the TELA APA, the Company was able to renegotiate the terms of the TELA-Regenity Supply Agreement, ultimately replacing it with a new Manufacturing and Supply Agreement (the “Supply Agreement”) with Regenity. The Supply Agreement maintains MIMEDX’s exclusive right to sell and market the product in the United States. The transaction was accounted for as an acquisition of assets, as substantially all the fair value of the acquired assets was concentrated in the acquired exclusive distribution rights. The cost to acquire the assets on the transaction date was $8.1 million, reflecting the $5.0 million of initial consideration, $0.4 million to acquire inventory, and $2.7 million, which represented the fair value of the minimum amount of the Profit Share Payments. These costs were allocated amongst the assets acquired. The Company assigned $7.6 million to the distribution rights acquired and $0.5 million to inventory. The amount ascribed to the distribution rights will be amortized over five years, generally reflective of the period of time over which the distribution rights are anticipated to contribute to cash flow generation. Any Profit Share Payments exceeding the $3.0 million minimum will be capitalized in the period incurred as part of the acquired assets and amortized over the remaining life of such assets. Form 10-K for the fiscal year ended December 31, 2023 Financial Statements 13. Discontinued Operations, page 1 2. Please provide us your analysis of how you determined that your disposal qualified as a strategic shift, as outlined in ASC 205-20-45-1B and 1C, in support of your discontinued operations accounting. Please identify and evaluate all relevant facts and circumstances. As part of your analysis, describe how you determined your Regenerative Medicine segment to be important to your operations and strategy, and a major part of your entity. The Company acknowledges the Staff’s comment. ASC 205-20-45-1B and 1C stipulates that a disposal of a component of an entity shall be reported in discontinued operations if it reflects a strategic shift that has (or will have) a major effect on an entity’s operations. The Company notes that there are no bright line tests for determining what represents a strategic shift and that this determination requires significant judgment. The Company historically organized its business on the basis of two reportable segments: Wound & Surgical and Regenerative Medicine. The Company’s Wound & Surgical segment focused on the Advanced Wound Care and Surgical areas of healthcare through sales of the Company’s existing product portfolio. Advanced Wound Care concerns the treatment of chronic wounds, defined and characterized as those that do not progress through the normal process of healing. Surgical applications range from involving the closure of an acute wound to those where our allografts are used inside the body to protect or reinforce tissues and/or regions of interest. The Company’s products that are used in these healthcare indications are generally regulated under Section 361 of the Public Health Services Act (“Section 361”). This regulatory pathway does not require any regulatory clearance from the FDA to sell products and, therefore, clinical trials are not conducted with the intention of achieving regulatory clearance. The Company actively sells these products in the United States. The Company’s Regenerative Medicine segment was singularly focused on research and development efforts associated with progressing the Company’s micronized dehydrated human amnion chorion membrane (“mDHACM”) in a specific indication of healthcare. Those indications of healthcare where the Company intended to sell mDHACM in the United States did not fall into either Advanced Wound Care or Surgical, as defined above; rather, the Company targeted degenerative musculoskeletal conditions as the primary use case for mDHACM, beginning with Knee Osteoarthritis. The Company believed that degenerative musculoskeletal conditions presented a significant potential source of value creation for the future. mDHACM did not meet all of the criteria for regulation solely under Section 361 and is regulated under Section 351 of the Public Health Services Act. This regulatory pathway required the Company to obtain a Biological License Application (“BLA”) with the FDA for a specific indication of health care. This required a series of clinical trials, which the Company was previously conducting. The Company was prohibited from selling and marketing mDHACM in the United States until a BLA was accepted by the FDA. The Company does note that it had historically presented the activities of its Regenerative Medicine business prominently in various public filings. For example, in an October 26, 2017, press release, the Company announced that it had commenced clinical trials for its mDHACM product to advance its BLA initiative and indicated that the market opportunity for the use of its mDHACM product in General Tendonitis and Osteoarthritic Knee Pain exceeded $12 billion. The status of these clinical trials and the status of the Company’s BLA efforts were given substantial discussion in the Company’s Annual Report on Form 10-K as of and for the year ended December 31, 2018, filed on March 1