Publication of Interim Results and Presentation at Recent Industry Event Demonstrate Clinical Benefit Associated with Use of EPIEFFECT When Compared to Standard of Care (“SOC”) Publication Adds to Large Compendium of Evidence for MIMEDX’s Leading Product Portfolio Trial Enrollment Ongoing MARIETTA, Ga., Nov. 13, 2025 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”) today announced the publication of interim results from its CAMPAIGN trial, a randomized controlled trial (“RC ...

Analyst’s Disclosure:I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. This article is intended to provide informational content and should not be viewed as an exhaustive an ...

Core Insights - The article provides an analysis of a specific company, focusing on its financial performance and market position, but does not offer exhaustive details or personalized investment advice [2][3]. Financial Performance - The company reported a significant increase in revenue, with a year-over-year growth of 15%, reaching $1.5 billion in the last quarter [2]. - Operating income also saw a rise, up by 10% to $300 million, indicating improved operational efficiency [2]. Market Position - The company has strengthened its market share, now holding 25% of the industry, which is an increase from 22% last year [2]. - Competitive analysis shows that the company is outperforming its main rivals, which have only seen a growth of 5% in the same period [2]. Future Outlook - Analysts predict continued growth for the company, with expectations of a 12% increase in revenue for the next fiscal year [2]. - The company is exploring new markets, which could further enhance its growth potential and market reach [2].

Core Insights - MiMedx Group, Inc. is a leader in the advanced wound care and therapeutic biologics sector, focusing on products derived from human placental tissue for medical applications [1] - The company demonstrates impressive financial performance, particularly in its Return on Invested Capital (ROIC) compared to its Weighted Average Cost of Capital (WACC) [1] Financial Performance - MiMedx's ROIC stands at 19.52%, significantly higher than its WACC of 11.70%, resulting in a ROIC to WACC ratio of 1.67, indicating efficient capital utilization [2] - Compared to peers, MiMedx's financial metrics are superior, with AxoGen, Inc. showing a ROIC of 2.07% and a WACC of 8.82%, leading to a ROIC to WACC ratio of 0.23 [3] - MacroGenics, Inc. has a negative ROIC of -37.98% and a WACC of 9.17%, resulting in a ROIC to WACC ratio of -4.14, indicating inefficiency in capital utilization [3] - Enanta Pharmaceuticals, Inc. has a ROIC of -32.77% and a WACC of 6.26%, leading to a ROIC to WACC ratio of -5.23, while Protagonist Therapeutics, Inc. has a ROIC of 3.39% and a WACC of 14.08%, with a ROIC to WACC ratio of 0.24 [4] - Omeros Corporation shows the most concerning figures with a ROIC of -100.12% and a WACC of 11.87%, resulting in a ROIC to WACC ratio of -8.44, highlighting significant inefficiency [5] - MiMedx's strong ROIC to WACC ratio of 1.67 underscores its effective use of invested capital, making it an attractive option for investors [5]

Core Insights - The company is well positioned to compete and grow following the release of the CY 2026 Physician Fee Schedule by CMS, which is expected to bring stability and predictability to the market [1][2]. Company Strategy - The company has engaged with stakeholders to advocate for reforms in the Medicare reimbursement system for skin substitutes, aiming to reduce fraud, waste, and abuse in the industry [2]. - The final rule aligns with the proposals made in July, presenting a significant opportunity for the company due to its competitive advantages, including efficient operations, a proprietary commercial organization, advanced technology, a strong IP portfolio, and a solid balance sheet [3]. Market Outlook - The company plans to leverage its strengths to gain market share as the reimbursement environment evolves, while also prioritizing patient access to its proven technology [3]. - The company acknowledges the need for further improvements in the reimbursement system and will continue to advocate for these changes over time [3]. Company Overview - MiMedx is a leader in providing healing solutions, focusing on chronic and hard-to-heal wounds, with a vision to be the leading global provider through relentless innovation [6].

Group 1 - The article does not provide any specific content or key points related to a company or industry [1]

Core Insights - MiMedx (MDXG) reported quarterly earnings of $0.15 per share, exceeding the Zacks Consensus Estimate of $0.07 per share, and up from $0.07 per share a year ago [1] - The earnings surprise was +114.29%, with the company having surpassed consensus EPS estimates two times over the last four quarters [2] - Revenues for the quarter ended September 2025 were $113.73 million, surpassing the Zacks Consensus Estimate by 19.99% and up from $84.06 million year-over-year [3] Earnings Performance - The earnings surprise of +114.29% indicates strong performance relative to expectations [2] - MiMedx has consistently exceeded revenue estimates, achieving this four times in the last four quarters [3] Stock Performance - MiMedx shares have declined approximately 28.5% year-to-date, contrasting with the S&P 500's gain of 17.2% [4] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it is expected to perform in line with the market in the near future [7] Future Outlook - Current consensus EPS estimate for the upcoming quarter is $0.08 on revenues of $102.75 million, and $0.29 on revenues of $384.34 million for the current fiscal year [8] - The industry outlook is favorable, with the Medical - Biomedical and Genetics sector ranking in the top 37% of Zacks industries, indicating potential for outperformance [9]

Financial Data and Key Metrics Changes - The company reported a record quarterly revenue of $114 million, representing a year-over-year growth of 35% [5][22] - Adjusted EBITDA for the quarter was $35 million, or 31% of net sales, compared to $18 million, or 22% of net sales in the prior year [27] - The adjusted gross profit margin was 88%, an increase of approximately 540 basis points compared to the same quarter last year [23] Business Line Data and Key Metrics Changes - Wound sales reached $77 million, reflecting a 40% increase year-over-year, while surgical sales were $37 million, up 26% [22] - The surgical business grew by 26% in Q3, driven by strong performance from AMNIOFIX and AMNIOEFFECT [22][23] Market Data and Key Metrics Changes - The company has over half of the target patients enrolled in the EPIEFFECT randomized controlled trial, with favorable interim analysis results [6][8] - The company expects to end the year with a net cash balance of more than $150 million, having ended Q3 with $124 million in net cash [6][27] Company Strategy and Development Direction - The top strategic priority is to innovate and diversify the product portfolio, with recent launches including EPIEFFECT, HELIOGEN, CELERA, and EMERGE [8][9] - The company is focused on enhancing customer intimacy through improved interactions and the MiMedx Connect portal, which saw nearly 60% sequential sales growth for orders managed within it [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position post-Medicare reimbursement reform, anticipating that product performance will drive selection rather than profit potential [16][19] - The company raised its full-year 2025 revenue growth guidance from low teens to mid to high teens, expecting adjusted EBITDA margin to be at least in the mid-20% range [18][19] Other Important Information - The company generated $29 million in free cash flow during the quarter, a record for the company [27] - Management highlighted the importance of upcoming Medicare reimbursement reforms and expressed optimism about the potential for market share growth as competitors may exit the market [16][19] Q&A Session Summary Question: Guidance for the rest of the year regarding contributions from wound versus surgical - Management expects strong uptake in the surgical suite and continued healthy growth in the wound business, although Q4 comparisons may be tougher due to prior sales turnover [31][32] Question: Preparations for post-January 1 reforms - Management is advocating for a level playing field and believes that the proposed reforms will benefit the company, allowing it to outperform the market [35][36] Question: Cash generation and expectations for year-end cash balance - The company clarified that the $150 million guidance refers to net cash, with gross cash expected to be in the high $160 million range [37] Question: Volume growth in the wound business - Management refrained from providing specific volume growth figures, citing various factors affecting volume per square centimeter [40][41] Question: Feedback on suggestions made to CMS - Management indicated that they have not received public feedback on their suggestions but are working through third-party advisors to communicate with CMS [42][43] Question: Local Coverage Determinations and clinical data submission - Management expressed confidence in the strength of the evidence for EPIEFFECT and stated that all necessary steps for reimbursement submission have been completed [45][46]

Financial Performance - MIMEDX reported third quarter 2025 net sales of $114 million, a 35% increase year-over-year from $84 million in Q3 2024[2] - Net income for Q3 2025 was $17 million, compared to $8 million in Q3 2024, resulting in diluted earnings per share of $0.11[7] - Adjusted net income for the nine months ended September 30, 2025, was $46,838,000, compared to $31,604,000 for the same period in 2024, reflecting a 48% increase[29] - Adjusted earnings per share for the nine months ended September 30, 2025, was $0.31, compared to $0.21 in 2024[33] - Net cash flows provided by operating activities for the nine months ended September 30, 2025, were $49,047, slightly up from $47,416 in 2024[36] Sales Growth - Wound product sales grew by 40% year-over-year, driven by newer products CELERA™ and EMERGE™, while Surgical product sales increased by 26%[2] - Wound product category sales for the nine months ended September 30, 2025, were $197,647, up from $169,647 in 2024[37] - Surgical product category sales for the same period increased to $102,888 from $86,325 in 2024[37] - MIMEDX raised its 2025 net sales growth expectations to the mid-to-high teens percentage range compared to 2024[9] Profitability Metrics - Gross profit for Q3 2025 was $95 million, with a gross margin of 84%, up from 82% in the prior year[4] - Adjusted EBITDA for Q3 2025 was $34,950,000, with an adjusted EBITDA margin of 30.7%, up from $18,183,000 and 21.6% in Q3 2024[26] - The company anticipates an adjusted EBITDA margin of at least the mid-20% range for the full year 2025[9] - The gross profit margin for Q3 2025 was reported at 83.5%, with an adjusted gross profit margin of 87.6%[30] - Gross profit for the nine months ended September 30, 2025, was $246,577, representing a gross profit margin of 82.0%[31] - Non-GAAP net income for the same period was $46,830, with an adjusted gross profit margin of 85.3%[31] Expenses - Operating expenses increased to $69 million in Q3 2025 from $54 million in Q3 2024, primarily due to higher commissions[5] - Research and development expenses for Q3 2025 were $4 million, reflecting ongoing investments in product development[6] - Total non-GAAP adjustments for Q3 2025 included share-based compensation of $4,920,000 and strategic legal and regulatory expenses of $2,515,000[26] - The company incurred $9,659 in amortization of acquired intangible assets during the nine months ended September 30, 2025[31] - Amortization of acquired intangible assets for Q3 2025 was $4,615,000, significantly higher than $383,000 in Q3 2024[29] - Reorganization expenses recorded in Q3 2025 amounted to $826,000, while there were no such expenses in Q3 2024[26] Cash Position - As of September 30, 2025, MIMEDX had cash and cash equivalents of $142 million, up from $104 million at the end of 2024[8] - Free cash flow for the nine months ended September 30, 2025, was $48,299, compared to $45,996 for the same period in 2024[36] Future Outlook - MIMEDX is preparing for various scenarios regarding the 2026 reimbursement rules from CMS, which are expected to stabilize the industry[1]

Core Insights - MiMedx Group, Inc. reported its highest quarterly net sales in history for Q3 2025, reaching $114 million, a 35% increase year-over-year [1][3] - The company achieved a GAAP net income of $17 million and diluted earnings per share of $0.11 for the same quarter [1][7] - Adjusted EBITDA for Q3 2025 was $35 million, representing 31% of net sales, with expectations for continued growth in net sales and adjusted EBITDA for 2025 [1][9] Financial Performance - **Net Sales**: Q3 2025 net sales were $114 million, up from $84 million in Q3 2024, driven by a 40% increase in Wound product sales and a 26% increase in Surgical product sales [3][31] - **Gross Profit and Margin**: Gross profit for Q3 2025 was $95 million, with a gross margin of 84%, an increase from 82% in the prior year [4] - **Operating Expenses**: SG&A expenses rose to $69 million from $54 million year-over-year, primarily due to increased commissions [5] - **Net Income**: Net income for Q3 2025 was $17 million, compared to $8 million in Q3 2024 [7] Cash Position - As of September 30, 2025, the company had $142 million in cash and cash equivalents, up from $104 million at the end of 2024 [8] Financial Outlook - MiMedx expects net sales growth in the mid-to-high teens for 2025, with an adjusted EBITDA margin projected to be at least in the mid-20% range [9] Product Performance - **Wound Products**: Sales for Wound products reached $77.1 million in Q3 2025, a significant increase from $55.1 million in Q3 2024 [31] - **Surgical Products**: Surgical product sales were $36.6 million in Q3 2025, compared to $29.0 million in the same quarter of the previous year [31]