Core Insights - The interim results from the CAMPAIGN trial indicate that MIMEDX's EPIEFFECT product shows significant clinical benefits compared to standard of care (SOC) wound treatment [1][2][3] - The study published in the International Journal of Tissue Repair highlights a posterior probability of 98.5% for EPIEFFECT's superiority over SOC based on 71 enrolled patients [4] - MIMEDX's CEO expressed optimism regarding the favorable results and the potential for successful outcomes upon the study's completion [5] Study Details - The CAMPAIGN trial is a randomized controlled trial designed to evaluate EPIEFFECT against SOC for managing nonhealing diabetic foot ulcers [2][3] - Enrollment for the trial is ongoing, with an expanded sample set of 88 patients presented at the Tissue Research Evidence Summit [3] - The study's success criteria were defined as a posterior probability greater than 90% [4] Market Implications - The interim analysis results strengthen the case for Medicare and commercial insurance coverage for EPIEFFECT, especially with upcoming Local Coverage Determination implementations scheduled for January 1, 2026 [6] - MIMEDX aims to position EPIEFFECT favorably within the healthcare market through demonstrated clinical efficacy [6] Company Overview - MIMEDX is a leader in providing solutions for chronic and hard-to-heal wounds, with a vision to be the leading global provider of healing solutions [7]

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]

Investor Presentation January 2025 Disclaimer & Cautionary Statements This presentation includes forward-looking statements. 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. Such forward-looking statements include statements regarding: Additional forward-looking statements may be identified by words such as "belie ...