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MIMEDX Announces Second Quarter 2024 Operating and Financial Results

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MIMEDX Group (NASDAQ: MDXG) reported Q2 2024 financial results with net sales of $87 million, up 7% year-over-year. The company achieved GAAP net income of $18 million and Adjusted EBITDA of $20 million (23% of net sales). Key highlights include:

- Launch of HELIOGEN™, a Fibrillar Collagen Matrix and first xenograft product
- Commencement of Randomized Controlled Trial for EPIEFFECT®
- Publication in Nature – Scientific Reports on surgical applications of placental-based allografts

Despite strong results, MIMEDX faced commercial challenges due to competitive behavior in the skin substitute market. The company expects mid-to-high single-digit net sales growth for 2024, with long-term projections of low double-digit growth and Adjusted EBITDA margin above 20%.

MIMEDX Group (NASDAQ: MDXG) ha comunicato i risultati finanziari del Q2 2024, con vendite nette di 87 milioni di dollari, in aumento del 7% rispetto all'anno precedente. L'azienda ha registrato un utile netto GAAP di 18 milioni di dollari e un EBITDA rettificato di 20 milioni di dollari (23% delle vendite nette). Tra i punti salienti ci sono:

- Lancio di HELIOGEN™, una matrice di collagene fibrillare e primo prodotto xenograft
- Inizio della sperimentazione clinica randomizzata per EPIEFFECT®
- Pubblicazione su Nature – Scientific Reports riguardo le applicazioni chirurgiche degli allograft a base placentare

Nonostante i risultati positivi, MIMEDX ha affrontato sfide commerciali a causa del comportamento competitivo nel mercato dei sostituti della pelle. L'azienda prevede una crescita delle vendite nette a cifra singola alta o media per il 2024, con proiezioni a lungo termine di una crescita a doppia cifra bassa e un margine EBITDA rettificato superiore al 20%.

MIMEDX Group (NASDAQ: MDXG) reportó resultados financieros del Q2 2024 con ventas netas de 87 millones de dólares, un aumento del 7% interanual. La compañía logró un ingreso neto GAAP de 18 millones de dólares y un EBITDA ajustado de 20 millones de dólares (23% de las ventas netas). Los puntos destacados incluyen:

- Lanzamiento de HELIOGEN™, una matriz de colágeno fibrilar y el primer producto xenoinjerto
- Inicio del ensayo clínico controlado aleatorio para EPIEFFECT®
- Publicación en Nature – Scientific Reports sobre aplicaciones quirúrgicas de aloinjertos basados en placenta

A pesar de los sólidos resultados, MIMEDX enfrentó desafíos comerciales debido al comportamiento competitivo en el mercado de sustitutos de piel. La compañía espera crecimiento de ventas netas de dígitos sencillos medio a alto para 2024, con proyecciones a largo plazo de crecimiento de dígitos dobles bajos y un margen de EBITDA ajustado superior al 20%.

MIMEDX 그룹 (NASDAQ: MDXG)는 2024년 2분기 재무 결과를 보고했으며, 순매출은 8,700만 달러로 전년 대비 7% 증가했습니다. 회사는 GAAP 기준 순이익 1,800만 달러조정된 EBITDA 2,000만 달러 (순매출의 23%)를 기록했습니다. 주요 하이라이트는 다음과 같습니다:

- HELIOGEN™ 출시, 섬유성 콜라겐 매트릭스 및 첫 엑스노이프트 제품
- EPIEFFECT®를 위한 무작위 대조 시험 개시
- 태반 기반 동종이식편의 외과적 적용에 대한 Nature – Scientific Reports에 발표

강력한 결과에도 불구하고, MIMEDX는 피부 대체 시장에서의 경쟁적 행동으로 인해 상업적 도전에 직면했습니다. 회사는 2024년에 중간에서 높은 단일 자릿수 판매 성장을 예상하며, 장기적으로는 낮은 두 자릿수 성장과 20% 이상의 조정된 EBITDA 마진을 예측하고 있습니다.

MIMEDX Group (NASDAQ: MDXG) a annoncé ses résultats financiers du T2 2024, avec des ventes nettes de 87 millions de dollars, en hausse de 7 % par rapport à l'année précédente. L'entreprise a réalisé un bénéfice net GAAP de 18 millions de dollars et un EBITDA ajusté de 20 millions de dollars (23 % des ventes nettes). Les points forts incluent :

- Lancement de HELIOGEN™, une matrice de collagène fibrillaire et premier produit xénogreffe
- Début d'un essai contrôlé randomisé pour EPIEFFECT®
- Publication dans Nature – Scientific Reports sur les applications chirurgicales des allogreffes à base de placenta

Malgré ces résultats solides, MIMEDX a rencontré des défis commerciaux en raison du comportement concurrentiel sur le marché des substituts cutanés. L'entreprise prévoit une croissance des ventes nettes à un chiffre moyen à élevé pour 2024, avec des prévisions à long terme de croissance à deux chiffres basse et une marge EBITDA ajustée supérieure à 20 %.

MIMEDX Group (NASDAQ: MDXG) hat die Finanzergebnisse für das 2. Quartal 2024 veröffentlicht, mit Nettoumsätzen von 87 Millionen Dollar, was einem Anstieg von 7 % im Vergleich zum Vorjahr entspricht. Das Unternehmen erzielte ein GAAP-Nettoeinkommen von 18 Millionen Dollar und ein bereinigtes EBITDA von 20 Millionen Dollar (23 % des Nettoumsatzes). Zu den wichtigsten Punkten gehören:

- Markteinführung von HELIOGEN™, einer fibrillären Kollagenmatrix und dem ersten Xenotransplantat-Produkt
- Beginn einer randomisierten kontrollierten Studie für EPIEFFECT®
- Veröffentlichung in Nature – Scientific Reports über chirurgische Anwendungen von placentabasierten Allo-Grafts

Trotz der starken Ergebnisse sah sich MIMEDX mit kommerziellen Herausforderungen aufgrund wettbewerbsbedingter Verhaltensweisen im Markt für Hautersatzprodukte konfrontiert. Das Unternehmen erwartet ein mittleres bis hohes einstelliges Umsatzwachstum für 2024, mit langfristigen Prognosen für niedriges zweistelliges Wachstum und einer bereinigten EBITDA-Marge von über 20 %.

Positive
  • Net sales increased 7% year-over-year to $87 million in Q2 2024
  • GAAP net income from continuing operations reached $18 million, with a 20% net income margin
  • Adjusted EBITDA of $20 million, representing a 23% margin
  • Launched HELIOGEN™, the company's first xenograft product
  • Commenced Randomized Controlled Trial for EPIEFFECT®
  • Published research on placental-based allografts in Nature – Scientific Reports
Negative
  • Faced commercial challenges due to competitive behavior in the skin substitute market
  • Experienced higher than normal employee and customer attrition
  • Ongoing uncertainty related to Medicare's reimbursement of skin substitute products
  • Reduced 2024 net sales growth forecast to mid-to-high single-digits due to market uncertainties

MIMEDX's Q2 2024 results demonstrate solid financial performance despite facing significant competitive challenges. Net sales grew 7% year-over-year to $87 million, while GAAP net income reached $18 million with a 20% margin. Adjusted EBITDA of $20 million and 23% margin show improved profitability.

However, the company faces headwinds from aggressive competitive practices in the skin substitute market. Some competitors are offering artificially high-priced products and sharing substantial revenues with physicians, leading to employee and customer attrition for MIMEDX. This situation poses a significant risk to future growth if left unchecked.

On the positive side, MIMEDX is expanding its product portfolio with the launch of HELIOGEN, its first xenograft product. This diversification could help offset challenges in other segments. The company's focus on clinical research, evidenced by recent publications, may provide a competitive edge in the long run.

Financial stability appears strong with $69 million in cash and cash equivalents, though this is down from year-end 2023. The repayment of a $30 million credit facility balance demonstrates prudent debt management.

While the 2024 outlook for mid-to-high single-digit growth is modest, the long-term projection of low double-digit growth and >20% adjusted EBITDA margin is encouraging, assuming the company can navigate current market challenges effectively.

MIMEDX's commitment to scientific research is evident in their recent publication in Nature - Scientific Reports, focusing on surgical applications of placental-based allografts. This dedication to high-quality clinical studies sets them apart in the regenerative medicine market and could be a key differentiator moving forward.

The launch of HELIOGEN, a Fibrillar Collagen Matrix and the company's first xenograft product, marks an important expansion of MIMEDX's product portfolio. This diversification into xenografts could open new market opportunities, particularly in surgical settings where such products are increasingly utilized.

The commencement of a Randomized Controlled Trial for EPIEFFECT is another positive development. RCTs are the gold standard for clinical evidence and could significantly strengthen MIMEDX's market position if results are favorable.

However, the ongoing challenges in the skin substitute market, particularly the practices of selling artificially high-priced products, pose a significant threat. These practices not only impact MIMEDX's current sales but could also influence future clinical adoption and reimbursement policies.

The uncertainty surrounding Medicare's reimbursement policies for skin substitutes in private office settings is a critical issue to monitor. Changes in these policies could have substantial impacts on MIMEDX's revenue streams and market dynamics.

The competitive landscape described by MIMEDX raises significant legal and ethical concerns. The company's assertion that competitors are engaging in schemes to sell artificially high-priced skin substitutes and sharing substantial portions of revenue with treating physicians could potentially violate anti-kickback statutes and other healthcare regulations.

MIMEDX's proactive approach in engaging with regulatory and legislative bodies to address these practices is prudent. However, the effectiveness and timeline of any potential regulatory action remain uncertain. This situation creates a challenging legal environment that could impact the entire industry.

The company's $10 million benefit from settlements with former officers and other matters in Q2 2024 is noteworthy. While this positively impacted the quarter's financials, it also suggests the resolution of previous legal issues, which could improve MIMEDX's standing and reduce future legal expenses.

The ongoing uncertainty related to Medicare's reimbursement policies for skin substitutes, based on recently proposed Local Coverage Determinations, presents another regulatory challenge. Changes in these policies could significantly affect MIMEDX's business model and the broader market for these products.

Investors should closely monitor developments in these legal and regulatory areas, as they could have substantial impacts on MIMEDX's competitive position and financial performance in the coming quarters.

Net Sales of $87 Million Grew 7% Year-Over-Year for the Second Quarter

Second Quarter GAAP Net Income and Earnings Per Share were $18 Million and $0.12, Respectively

Second Quarter Adjusted EBITDA was $20 Million, or 23% of Net Sales

Management to Host Conference Call Today, July 31, 2024, at 4:30 PM ET

MARIETTA, Ga., July 31, 2024 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”), today announced operating and financial results for the second quarter 2024.

Recent Operating and Financial Highlights:

  • Second quarter 2024 net sales of $87 million, reflecting 7% growth over the prior year period.
  • GAAP net income from continuing operations and net income margin for the second quarter 2024 of $18 million and 20%, respectively.
  • Adjusted EBITDA and Adjusted EBITDA margin for the second quarter 2024 of $20 million and 23%, respectively.
  • Announced publication focused on surgical applications using MIMEDX placental-based allografts in Nature – Scientific Reports.
  • Launched HELIOGEN™, a Fibrillar Collagen Matrix and the Company's first xenograft product.
  • Commenced Randomized Controlled Trial for EPIEFFECT®.

Joseph H. Capper, MIMEDX Chief Executive Officer, commented, "Our second quarter 2024 results were marked by exceptional resolve, focus and execution, resulting in total net sales growth of 7% year-over-year and an Adjusted EBITDA margin of 23%, both compared to a strong second quarter in 2023. During the quarter, we faced commercial challenges as a result of certain competitive behavior. Specifically, several companies continue to engage in schemes to sell artificially high-priced, yet clinically unproven, skin substitutes primarily in the private office, by sharing a substantial portion of the revenue with treating physicians. Since remedial action has yet to be implemented, these selling practices have escalated dramatically, reaching a fevered pitch as of late. As a result, we unfortunately experienced higher than normal employee and customer attrition during the quarter as people were swept up by the promise of riches."

Mr. Capper continued, "We are in active dialogue with several regulatory and legislative bodies in an effort to promote positive change in this area. Despite these near-term challenges, we are enthusiastic about our progress in pursuit of the company's long-term priorities. We are excited for the full market release of our first xenograft product, HELIOGEN, to help drive the continued expansion of our footprint in various surgical settings. Our commitment to high-quality clinical and scientific research is unmatched in our market, as evidenced by our recent peer-reviewed publication in Nature - Scientific Reports."

 Three Months Ended June 30, Six Months Ended June 30,
  2024   2023   2024   2023 
Net Income$        17,625  $        1,200  $        26,886  $        (3,783)
Non-GAAP Adjustments:       
Depreciation expense         577           687           1,135           1,401 
Amortization of intangible assets         572           191           761           380 
Interest (income) expense, net         (3)          1,630           1,687           3,184 
Income tax provision expense (benefit), net         5,595           (74)          7,944           (23)
Share-based compensation         4,091           4,060           8,431           8,405 
Investigation, restatement and related expenses         (9,701)          1,017           (9,390)          4,690 
Impairment of intangible assets         —           —           54           — 
Transaction related expenses         484           —           556           — 
Extraordinary legal and regulatory expenses         581           —           631           — 
Expenses related to disbanding of Regenerative Medicine Business Unit         (4)          5,391           (204)          5,391 
Adjusted EBITDA$        19,817  $        14,102  $        38,491  $        19,645 
Adjusted EBITDA margin         22.7%          17.4%          22.4%          12.8%


Second Quarter 2024 Results Discussion
1

Net Sales

MIMEDX reported net sales for the three months ended June 30, 2024, of $87 million, compared to $81 million for the three months ended June 30, 2023, an increase of 7%. The increase was primarily driven by growing contributions from its AMNIOEFFECT® and EPIEFFECT® products, partially offset by commercial challenges associated with competitive behavior in the marketplace, namely the sale of artificially high-priced skin substitute products and the ongoing uncertainty related to Medicare's reimbursement of these products, based upon recently proposed Local Coverage Determinations, and headwinds relating to turnover of certain of our sales team and customers.

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

Gross Profit and Margin

Gross profit for the three months ended June 30, 2024, was $72 million, an increase of $5 million as compared to the prior year period. Gross margin for the three months ended June 30, 2024 was 83.0%, compared to 83.3% in the prior year period. The year-over-year reduction in gross margin was driven by the amortization of distribution rights stemming from the TELA Bio, Inc. and Regenity Biosciences agreements entered into during the first quarter of 2024. Excluding this amortization expense, gross margin for the second quarter was roughly flat compared to the prior year period.

Operating Expenses

Selling, general and administrative ("SG&A") expenses for the three months ended June 30, 2024, were $55 million compared to $52 million for the three months ended June 30, 2023. The increase in SG&A was driven by year-over-year increases in compensation related to higher salary and benefit costs from merit raises, promotions, as well as commissions driven by increases in sales volumes and proportionally higher sales through sales agents. Incremental spend from legal and regulatory disputes in the current period also contributed to the increase.

Research and development expenses for the three months ended June 30, 2024, were $3 million compared to $4 million for the three months ended June 30, 2023. The decrease was the result of lower headcount and the timing of R&D activities compared to the prior year.

Investigation, restatement and related expense for the three months ended June 30, 2024, was a benefit of $10 million compared to expense of $1 million for the three months ended June 30, 2023. The benefit in the second quarter 2024 resulted from various settlements, including those with former officers and other matters.

Net income from continuing operations for the three months ended June 30, 2024 was $18 million compared to $9 million for the three months ended June 30, 2023.

Cash and Cash Equivalents

As of June 30, 2024, the Company had $69 million of cash and cash equivalents compared to $82 million as of December 31, 2023. The decrease during the period ended June 30, 2024 was primarily a result of our repaying the $30 million outstanding balance on our revolving credit facility in the first quarter of 2024, as well as the $5 million cash payment also in the first quarter 2024 associated with our agreement with TELA Bio, Inc., paving the way for our exclusive manufacturing and supply agreement with Regenity Biosciences. The decrease was partially offset by year-over-year increases in net sales, which drove increases in collections from customers.

Financial Outlook
For 2024, MIMEDX expects net sales growth to be in the mid-to-high single-digits as a percentage compared to 2023, due principally to the ongoing uncertainty surrounding Medicare reimbursement policy for skin substitutes in the private office and adjacent care settings.

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

Conference Call and Webcast

MIMEDX will host a conference call and webcast to review its second quarter 2024 results on Wednesday, July 31, 2024, beginning at 4:30 p.m., Eastern Time. The call can be accessed using the following information:

Webcast: Click here
U.S. Investors: 877-407-6184
International Investors: 201-389-0877
Conference ID: 13747365

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

Important Cautionary Statement

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

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

About MIMEDX

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

Contact:
Matt Notarianni
Investor Relations
470.304.7291
mnotarianni@mimedx.com 


Selected Unaudited Financial Information

 
MiMedx Group, Inc.
Condensed Consolidated Balance Sheets
(in thousands) Unaudited
 June 30, 2024 December 31, 2023
ASSETS   
Current assets:   
Cash and cash equivalents$        69,037  $        82,000 
Accounts receivable, net         52,798           53,871 
Inventory         25,056           21,021 
Prepaid expenses         4,030           5,624 
Other current assets         3,097           1,745 
Total current assets         154,018           164,261 
Property and equipment, net         6,822           6,974 
Right of use asset         3,175           2,132 
Deferred tax asset, net         33,441           40,777 
Goodwill         19,441           19,441 
Intangible assets, net         12,047           5,257 
Other assets         1,239           205 
Total assets$        230,183  $        239,047 
LIABILITIES AND STOCKHOLDERS’ EQUITY   
Current liabilities:   
Current portion of long term debt$        1,000  $        1,000 
Accounts payable         7,603           9,048 
Accrued compensation         17,645           22,353 
Accrued expenses         9,281           9,361 
Current portion of Profit Share Payments         2,196           — 
Current liabilities of discontinued operations         217           1,352 
Other current liabilities         2,070           2,894 
Total current liabilities         40,012           46,008 
Long term debt, net         18,249           48,099 
Other liabilities         3,882           2,223 
Total liabilities         62,143           96,330 
Total stockholders' equity         168,040           142,717 
Total liabilities and stockholders’ equity$        230,183  $        239,047 


 
MiMedx Group, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts) Unaudited
 Three Months Ended June 30, Six Months Ended June 30,
  2024   2023   2024   2023 
        
Net sales$        87,207  $        81,257  $        171,915  $        152,933 
Cost of sales         14,855           13,583           27,841           26,002 
Gross profit         72,352           67,674           144,074           126,931 
        
Operating expenses:       
Selling, general and administrative         55,401           51,955           110,530           104,203 
Research and development         3,012           3,672           5,852           7,156 
Investigation, restatement and related         (9,701)          1,017           (9,390)         4,690 
Amortization of intangible assets         190           191           379           380 
Impairment of intangible assets         —           —           54           — 
Operating income         23,450           10,839           36,649           10,502 
        
Other expense, net       
Interest income (expense), net         3           (1,630)          (1,687)          (3,184)
Other expense, net         (237)          (32)          (336)          (32)
Income from continuing operations before income tax provision         23,216           9,177           34,626           7,286 
Income tax provision (expense) benefit from continuing operations         (5,595)          74           (7,944)          23 
Net income from continuing operations         17,621           9,251           26,682           7,309 
Income (loss) from discontinued operations, net of tax         4           (8,051)          204           (11,092)
Net income (loss)$        17,625  $        1,200  $        26,886  $        (3,783)
        
Net income available to common stockholders from continuing operations$        17,621  $        7,523  $        26,682  $        3,898 
        
Basic net income (loss) per common share:       
Continuing operations         0.12           0.07           0.18           0.04 
Discontinued operations         —           (0.07)          —           (0.10)
Basic net income (loss) per common share$        0.12  $        (0.00) $        0.18  $        (0.06)
        
Diluted net income (loss) per common share:       
Continuing operations$        0.12  $        0.06           0.18           0.04 
Discontinued operations         0.00           (0.05)          —           (0.10)
Diluted net income (loss) per common share$        0.12  $        0.01  $        0.18  $        (0.06)
        
Weighted average common shares outstanding - basic 147,326,273   115,866,371   147,033,879   115,136,646 
Weighted average common shares outstanding - diluted 148,897,920   146,862,924   149,211,012   115,849,854 


 
MiMedx Group, Inc.
Condensed Consolidated Statements of Cash Flows
(in thousands) Unaudited
 Six Months Ended June 30,
  2024   2023 
Net cash flows provided by operating activities from continuing operations         28,722           12,567 
Net cash flows used in operating activities of discontinued operations         (930)          (8,840)
Net cash flows provided by operating activities$        27,792  $        3,727 
Net cash flows used in investing activities (6,929)  (1,025)
Net cash flows used in financing activities         (33,826)          — 
Net change in cash$        (12,963) $        2,702 


Reconciliation of Non-GAAP Measures

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

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

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

Adjusted EBITDA and Adjusted EBITDA margin

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

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

Adjusted Net Income (Loss)

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

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

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

 Three Months Ended June 30, Six Months Ended June 30,
  2024   2023   2024   2023 
Net income (loss)$        17,625  $        1,200  $        26,886  $        (3,783)
Loss on extinguishment of debt         —           —           1,401           — 
Investigation, restatement and related expenses         (9,701)          1,017           (9,390)          4,690 
Impairment of intangible assets         —           —           54           — 
Amortization of acquired intangible assets         382           —           382           — 
Transaction related expenses         484           —           556           — 
Strategic legal and regulatory expenses         581           —           631           — 
Expenses related to disbanding of Regenerative Medicine Business Unit         (4)          5,391           (204)          5,391 
Long-term effective income tax rate adjustment         1,855           (1,958)          879           (1,592)
Adjusted net income$        11,222  $        5,650  $        21,195  $        4,706 


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

 Three Months Ended June 30, 2024
 Gross Profit Selling, General & Administrative Expense Research and Development Expense Net Income
Reported GAAP Measure$        72,352  $        55,401  $        3,012  $        17,625 
Investigation, restatement and related expenses         —           —           —           (9,701)
Amortization of acquired intangible assets         382           —           —           382 
Transaction related expenses         —           (414)          —           484 
Strategic legal and regulatory expenses         —           (581)          —           581 
Expenses related to disbanding of Regenerative Medicine Business Unit         —           —           —           (4)
Long-term effective income tax rate adjustment         —           —           —           1,855 
Non-GAAP Measure$        72,734  $        54,406  $        3,012  $        11,222 
        
Gross Profit Margin         83.0%      
Gross Profit Margin, as adjusted         83.4%      


 Three months ended June 30, 2023
 Gross Profit Selling, General & Administrative Expense Research and Development Expense Net Income
Reported GAAP Measure$        67,674  $        51,955  $        3,672  $        1,200 
Investigation, restatement and related expenses         —           —           —           1,017 
Expenses related to disbanding of Regenerative Medicine Business Unit         —           —           —           5,391 
Long-term effective income tax rate adjustment         —           —           —           (1,958)
Non-GAAP Measure$        67,674  $        51,955  $        3,672  $        5,650 
        
Gross Profit Margin         83.3%      
Gross Profit Margin, as adjusted         83.3%      


 Six Months Ended June 30, 2024
 Gross Profit Selling, General & Administrative Expense Research and Development Expense Net Income
Reported GAAP Measure$        144,074  $        110,530  $        5,852  $        26,886 
Loss on extinguishment of debt         —           —           —           1,401 
Investigation, restatement and related expenses         —           —           —           (9,390)
Impairment of intangible assets         —           —           —           54 
Amortization of acquired intangible assets         382           —           —           382 
Transaction related expenses         —           (486)          —           556 
Strategic legal and regulatory expenses         —           (631)          —           631 
Expenses related to disbanding of Regenerative Medicine Business Unit         —           —           —           (204)
Long-term effective income tax rate adjustment         —           —             879 
Non-GAAP Measure$        144,456  $        109,413  $        5,852  $        21,195 
        
Gross Profit Margin         83.8%      
Gross Profit Margin, as adjusted         84.0%      


 Six Months Ended June 30, 2023
 Gross Profit Selling, General & Administrative Expense Research and Development Expense Net (Loss) Income
Reported GAAP Measure$        126,931  $        104,203  $        7,156  $        (3,783)
Investigation, restatement and related expenses         —           —           —           4,690 
Expenses related to disbanding of Regenerative Medicine Business Unit         —           —           —           5,391 
Long-term effective income tax rate adjustment         —           —             (1,592)
Non-GAAP Measure$        126,931  $        104,203  $        7,156  $        4,706 
        
Gross Profit Margin         83.0%      
Gross Profit Margin, as adjusted         83.0%      


Adjusted Earnings Per Share

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

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

 Three Months Ended June 30, Six Months Ended June 30,
  2024   2023   2024   2023 
GAAP net income (loss) per common share - diluted$        0.12  $        0.01  $        0.18  $        (0.06)
Loss on extinguishment of debt         0.00           0.00           0.01           0.00 
Investigation, restatement and related (benefit) expense         (0.07)          0.01           (0.06)          0.04 
Impairment of intangible assets         0.00           0.00           0.00           0.00 
Amortization of acquired intangible assets         0.00           0.00           0.00           0.00 
Transaction related expenses         0.01           0.00           0.00           0.00 
Strategic legal and regulatory expenses         0.01           0.00           0.00           0.00 
Expenses related to disbanding of Regenerative Medicine business unit         0.00           0.05           0.00           0.05 
Long-term effective income tax rate adjustment         0.01           (0.02)          0.01           (0.01)
Effects of antidilution         0.00           (0.02)          0.00           0.00 
Adjusted Earnings Per Share$        0.08  $        0.03  $        0.14  $        0.02 
        
GAAP weighted average common shares outstanding - diluted         148,897,920           146,862,924           149,211,012           115,849,854 
Effects of antidilution         —           (29,997,271)          —           — 
Weighted average common shares outstanding - adjusted         148,897,919           116,865,653           149,211,012           115,849,854 


Free Cash Flow

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

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

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

 Three Months Ended June 30, Six Months Ended June 30,
  2024   2023   2024   2023 
Net cash flows provided by operating activities$        21,814  $        7,775  $        27,792  $        3,727 
Capital expenditures, including purchases of equipment         (105)          (299)          (1,249)          (932)
Free Cash Flow$        21,709  $        7,476  $        26,543  $        2,795 


Net Sales by Product Category by Quarter

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

 2023 2024
 Q1 Q2 Q3 Q4 Q1 Q2
Wound$        45,206  $        53,319  $        51,156  $        55,980  $        57,049  $        57,546 
Surgical         26,468           27,939           30,557           30,852           27,660           29,660 
Net sales$        71,674  $        81,258  $        81,713  $        86,832  $        84,709  $        87,206 



FAQ

What were MIMEDX's Q2 2024 financial results?

MIMEDX reported Q2 2024 net sales of $87 million, up 7% year-over-year, with GAAP net income of $18 million and Adjusted EBITDA of $20 million (23% of net sales).

What new product did MIMEDX launch in Q2 2024?

MIMEDX launched HELIOGEN™, a Fibrillar Collagen Matrix and the company's first xenograft product.

What challenges did MIMEDX face in Q2 2024?

MIMEDX faced commercial challenges due to competitive behavior in the skin substitute market, leading to higher employee and customer attrition, and ongoing uncertainty related to Medicare reimbursement policies.

What is MIMEDX's financial outlook for 2024?

MIMEDX expects net sales growth in the mid-to-high single-digits for 2024, with long-term projections of low double-digit growth and Adjusted EBITDA margin above 20%.

MiMedx Group, Inc

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