Management is transitioning the company to focus exclusively on drug-eluting biologics, specifically targeting the high infection rates in breast reconstruction surgery. Performance attribution for the quarter was driven by a return to direct distribution for cardiovascular and SimpliDerm lines, improving adjusted gross margins to 66.8%. The strategic rationale for the NXT 41X platform is based on addressing a 15% to 20% postoperative infection rate that current systemic antibiotics fail to reach due ...

Financial Data and Key Metrics Changes - The company reported revenue of $3.3 million for Q4 2025, a 16% increase from $2.8 million in the same quarter last year [35] - Adjusted gross margin for Q4 2025 was 66.8%, up 12 percentage points from 56.5% in the prior year [35] - Net loss from continuing operations was $6.5 million, an improvement from $7.2 million a year ago [36] - Adjusted EBITDA loss was $4.2 million, compared to a loss of $3.4 million in the previous year [36] - Total cash on hand, including $8 million in escrow, was $44.4 million after paying off $28 million in debt [36][37] Business Line Data and Key Metrics Changes - The return to direct distribution positively impacted revenue for both cardiovascular and SimpliDerm product lines [35] - The company is focusing on the launch of NXT-41, which is expected to be transformational in the market [40] Market Data and Key Metrics Changes - The breast reconstruction market is valued at $1.5 billion, with 162,000 breasts reconstructed annually after mastectomy [11][12] - The company aims to address the 15%-20% postoperative infection rate in breast reconstruction patients, which is a significant issue in the market [11][12] Company Strategy and Development Direction - The company is committed to "humanizing medicine" and solving significant problems in breast reconstruction [7][11] - The strategic focus is on the development and commercialization of NXT-41 and NXT-41X, which are designed to reduce postoperative infections [23][40] - The company is exploring strategic options for SimpliDerm to concentrate resources on the NXT-41X program [29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's technology platform and its potential to transform the market [42] - The company is well-resourced with a strong balance sheet and a capable team, positioning it for future growth [42] - Management acknowledged the challenges of the FDA review process but emphasized preparedness and a high-quality application for NXT-41 [48] Other Important Information - The company has added key personnel to its team, including a new Chief Commercial Officer to lead commercial efforts for NXT-41X [10] - Elutia has been recognized as a great place to work, which is expected to enhance its ability to attract talent and outperform financial metrics [32][33] Q&A Session Summary Question: What kind of questions are you preparing for from the FDA regarding NXT-41? - Management emphasized the importance of submitting a high-quality application and being prepared to explain their rationale for responses [46][47] Question: How quickly can you shift the filing to NXT-41X after NXT-41 approval? - Management indicated that the team plans to efficiently transition from NXT-41 to NXT-41X based on learnings from the initial submission [49][50] Question: How does SimpliDerm experience contribute to commercial readiness for NXT-41X? - Management highlighted the understanding of market dynamics and reimbursement processes gained from SimpliDerm, which will aid in the commercialization of NXT-41X [51][52] Question: How do you think NXT-41X will compare in infection reduction to other techniques? - Management expressed optimism for a significant reduction in infection rates with NXT-41X, citing advantages in uniform distribution and sustained antibiotic delivery [56][57]

Financial Data and Key Metrics Changes - The company reported revenue of $3.3 million for the fourth quarter, a 16% increase from $2.8 million in the same quarter last year [35] - Adjusted gross margin for the fourth quarter was 66.8%, up 12 points from 56.5% in the prior year quarter [35] - Net loss from continuing operations was $6.5 million, an improvement from $7.2 million a year ago [36] - Total cash on hand, including $8 million in escrow, was $44.4 million after paying off $28 million in debt [36][39] Business Line Data and Key Metrics Changes - The return to direct distribution positively impacted revenue for both cardiovascular and SimpliDerm product lines [35] - The company divested its BioEnvelope business, which generated $88 million, allowing for a focus on the NXT-41 product line [39] Market Data and Key Metrics Changes - The breast reconstruction market is valued at $1.5 billion, with 162,000 breasts reconstructed annually after mastectomy [11][12] - The company aims to address the 15%-20% postoperative infection rate in breast reconstruction patients, which is a significant market challenge [11][13] Company Strategy and Development Direction - The company is focused on solving the problem of postoperative infections in breast reconstruction through its NXT-41X product, which combines a biological matrix with sustained antibiotic release [11][24] - The strategic reset includes a focus on the NXT-41 product line, with plans for FDA submission and commercialization [39][41] - The company is exploring strategic options for SimpliDerm to concentrate resources on NXT-41X [30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the NXT-41 product's potential to transform the market and emphasized the importance of addressing high infection rates in breast reconstruction [39][41] - The company is well-resourced with a strong balance sheet and a capable team, positioning it for future growth [41] Other Important Information - The company has been recognized as a Great Place to Work, which is expected to enhance its ability to attract talent and improve financial performance [32][33] - The company has a manufacturing facility capable of generating $120 million in revenue for NXT-41X [28] Q&A Session Summary Question: What kind of questions are you preparing for from the FDA regarding NXT-41? - Management indicated that they are preparing for questions related to biocompatibility and have retained supporting data for their application [45][46] Question: How quickly can you shift the filing to NXT-41X after NXT-41 approval? - Management stated that the plan is to transition efficiently from NXT-41 to NXT-41X, learning from the NXT-41 submission process [49] Question: How does SimpliDerm experience help with commercial readiness for NXT-41X? - Management highlighted that understanding the market and reimbursement processes, along with building relationships with key opinion leaders, are crucial for commercial readiness [51][53] Question: How do you think NXT-41X will compare in infection reduction to other techniques? - Management expressed confidence that NXT-41X could achieve significant infection reduction, emphasizing its advantages in uniform distribution and sustained antibiotic release [55][56]

4Q2025 Earnings Call C. Randal Mills PhD Chief Executive Officer Matt Ferguson Chief Financial Officer March 11, 2026 Forward-Looking Statements This presentation contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward- looking statements can be identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates ...

Core Insights - Elutia Inc. has submitted its base biologic matrix NXT-41 to the FDA, expecting clearance in the second half of 2026 and full clearance for NXT-41x in the first half of 2027 [1][4] - The company reported $44.4 million in cash and escrowed proceeds at year-end 2025 [1] - Elutia's CEO emphasized the effectiveness of their drug-eluting biologic platform and the need for improvement in the breast cancer surgery market, which is valued at $1.5 billion [3] Business Highlights - The divestiture of the BioEnvelope business for $88 million has allowed Elutia to eliminate debt and refocus on its core operations [3][4] - Surgeon engagement indicates strong potential for NXT-41x in reducing post-operative infection rates, which currently stand at 15-20% in the breast cancer surgery market [4] - The company has strengthened its leadership team to support the commercialization of NXT-41x, with new appointments including Guido J. Neels and Pete Ligotti [4] Financial Performance - For Q4 2025, net sales increased to $3.3 million, a 16% rise from $2.8 million in Q4 2024 [5] - Full-year 2025 net sales were reported at $12.3 million, down from $14.5 million in 2024, primarily due to changes in distribution models [6][7] - The gross margin on a GAAP basis improved to 58.5% in Q4 2025 from 46.9% in Q4 2024, while adjusted gross margin rose to 66.8% from 56.5% [7][18] Balance Sheet and Cash Position - As of December 31, 2025, Elutia had a cash balance of $36.4 million, with an additional $8.0 million held in escrow related to the BioEnvelope divestiture [7][16] - The company has transformed its balance sheet by repaying $26.9 million in outstanding debt during Q4 2025 [4][7] Strategic Initiatives - Elutia has initiated a strategic process to explore options for its SimpliDerm product line, aiming to focus resources on the upcoming launch of NXT-41x [4]

Financial Data and Key Metrics Changes - Elutia reported Q3 2025 revenue of $3.3 million, down from $3.6 million in the same quarter last year, but gross margin improved to 55.8% from 49% a year ago [39][40] - Adjusted gross margin, excluding non-cash amortization, was 64% compared to 56% in the prior year [40] - Operating expenses decreased to $7.1 million from $11 million a year ago, resulting in a loss from operations of $5.2 million, down from $9 million [40] Business Line Data and Key Metrics Changes - SimpliDerm revenue increased by 18% from Q2 2025 to $2.4 million, although it was down from the previous year due to various factors [35] - Cardiovascular product sales reached $900,000 in Q3 2025, up 68% year-over-year and 28% sequentially [38] Market Data and Key Metrics Changes - The breast reconstruction market is valued at $1.5 billion, with 162,000 procedures performed annually in the U.S. [11][12] - Post-operative infection rates in breast reconstruction are reported to be between 15%-20%, highlighting a significant unmet medical need [10][11] Company Strategy and Development Direction - Elutia aims to leverage its validated technology platform to address the unmet medical need in breast reconstruction through the development of NXT 41 and NXT 41X products [10][29] - The company plans to utilize its existing commercial infrastructure from SimpliDerm to support the launch of NXT 41 and NXT 41X [49] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's future, emphasizing the importance of the recent sale of the bio-envelope business to Boston Scientific for $88 million, which strengthens the balance sheet and operational efficiency [32][33] - The company is focused on resolving legacy litigation issues, with only six cases remaining from an initial 110, indicating a move towards a cleaner operational slate [42] Other Important Information - The company has a robust manufacturing facility in Gaithersburg, Maryland, which is expected to support the production of NXT 41 and NXT 41X without delays [55] - Elutia has resolved seven legacy litigation cases in the quarter, reducing the total to six remaining cases with an estimated liability of $700,000 [42] Q&A Session Summary Question: Insights from Eliupro's development to commercial rollout - Management highlighted the importance of having a strong team and commercial infrastructure in place, which contributed to Eliupro's successful market entry [46][47] Question: Leveraging SimpliDerm for NXT - The existing relationships and commercial presence from SimpliDerm will be utilized to facilitate the adoption of NXT 41X, as both products target the same customer base [49] Question: Clinical evidence and data generation for NXT - While there is no requirement for clinical data for the 510(k) pathway, the company plans to generate strong clinical evidence to support the product's market adoption [51][53] Question: Manufacturing plans for NXT and 41X - The manufacturing of NXT and 41X will occur in a separate GMP facility, ensuring compliance with regulations and readiness for production [54][55] Question: Current run rate and growth sustainability for cardiovascular business - The cardiovascular business is expected to achieve steady growth, with a current run rate of approximately $1 million per quarter, benefiting from high gross margins [57]

Core Insights - Elutia Inc. is advancing its NXT-41x biomatrix technology to address a significant unmet medical need in plastic and reconstructive surgery, targeting a market opportunity estimated at $1.5 billion in the U.S. [1][5] Business Highlights - The CEO emphasized the importance of addressing infection in breast reconstruction, which affects 15-20% of cases, and highlighted the company's antibiotic-eluting technology aimed at preventing such infections [4]. - Elutia sold its BioEnvelope business to Boston Scientific for $88 million, with proceeds allocated to eliminate debt and fund the NXT-41x development program [5]. - The company is progressing with the NXT-41x biomatrix, which is expected to receive FDA clearance for the base matrix in the second half of 2026 and for the drug-eluting version in the first half of 2027 [5]. - Elutia's balance sheet has been strengthened through the sale of the BioEnvelope business, allowing for the full funding of the NXT-41x platform development without shareholder dilution [5]. - Guido J. Neels has been appointed to the Board of Directors, bringing experience from his previous role as COO of Guidant Corporation [5]. Financial Results - For Q3 2025, Elutia reported net sales of $3.3 million, a decrease from $3.7 million in Q3 2024, with SimpliDerm sales at $2.4 million and cardiovascular products at $0.9 million [6]. - The gross margin on a GAAP basis improved to 55.8% from 48.9% year-over-year, while the adjusted gross margin rose to 63.9% from 56.3% [6][20]. - Total operating expenses decreased to $7.1 million from $11.0 million, resulting in a loss from operations of $5.2 million, down from $9.2 million in the prior year [6]. - The net loss from continuing operations was $0.4 million, compared to a net income of $3.3 million in Q3 2024 [6]. - As of September 30, 2025, the cash balance was $4.7 million, bolstered by $80.3 million received from the BioEnvelope business sale [7]. Market Opportunity - The NXT-41x biomatrix is positioned to tackle serious complications faced by one in three patients undergoing breast reconstruction, addressing a critical need in the $1.5 billion U.S. market [5].

Financial Data and Key Metrics Changes - The company reported a 33% year-over-year increase in bioenvelope revenue for the quarter, reaching a run rate of approximately $14 million [10] - Elupro revenue grew 49% sequentially, now accounting for 68% of total bioenvelope revenue [10][12] - Adjusted gross margin improved to 62.4%, up over four percentage points from the previous year [34] - The company ended Q2 with $8.5 million in cash, indicating a stable financial position [36] Business Line Data and Key Metrics Changes - Elupro's sales per account are 130% higher than the previous product, Kangaroo, reflecting greater utilization [13] - The cardiovascular patch products generated over $700,000 in revenue for a partial quarter, more than double the previous distributor's revenue [32] - SimpliDerm revenue decreased to $2 million, indicating potential for improvement in that product line [33] Market Data and Key Metrics Changes - The breast reconstruction market is valued at $1.5 billion in the U.S., with biologics accounting for 65% of device-related spending [20] - Approximately 317,000 women are diagnosed with invasive breast cancer annually, leading to significant market potential for reconstruction products [19] Company Strategy and Development Direction - The company aims to scale Elupro by increasing the number of VAC approvals and GPO coverage [38] - The NXT 41 platform is positioned to address significant unmet medical needs in breast reconstruction, with anticipated market launch in 2026 [25][40] - The company is exploring strategic opportunities that may positively impact cash position in the near future [36][41] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of Elupro, citing predictable ordering patterns and strong hospital partnerships [46][50] - The company is focused on addressing the high complication rates in breast reconstruction procedures, emphasizing the need for innovative solutions [22][23] Other Important Information - The company has settled 97 out of 110 lawsuits related to a past product recall, significantly reducing future expenses and legal overhang [29][30] - The company is actively working on business development transactions, with expectations for announcements in the near future [41] Q&A Session Summary Question: What are the bottlenecks in the Elupro launch? - Management noted initial production challenges but emphasized that operations have now stabilized, allowing for efficient scaling [45][46] Question: Can you clarify the NXT 41 launch timeline? - The base matrix is expected to launch in 2026, followed by the drug-eluting version in 2027, with a focus on regulatory strategy [52][56] Question: How can gross margins be maintained or expanded? - Management highlighted opportunities for margin improvement across all business segments, particularly in Elupro and cardiovascular products [64] Question: What level of clinical evidence is needed for NXT 41? - The company plans to follow a similar regulatory pathway as Elupro, focusing on generating clinical data for marketing purposes [67]

Core Insights - Elutia Inc. reported a significant revenue increase for its EluPro product, with a 49% sequential growth in Q2 2025 and a 33% year-over-year increase in total BioEnvelope sales, reaching $3.5 million [2][5][6] - The company is advancing its next-generation drug-eluting biomatrix, NXT-41, targeting a $1.5 billion market for breast reconstruction, with initial product launch planned for the second half of 2026 [2][4] Business Highlights - EluPro has become the preferred choice in cardiac implantable electronic device procedures, expanding into over 160 VAC-approved hospitals and growing its customer base more than 15 times since launch [4][6] - The average sales per EluPro customer were 130% higher than those for the legacy CanGaroo platform, indicating stronger market penetration [6] - Elutia has received two awards for innovation and product launches, and has published five peer-reviewed articles on EluPro, showcasing its scientific leadership [6] Financial Performance - For Q2 2025, Elutia's overall net sales were $6.3 million, nearly unchanged from Q2 2024, with a gross margin of 48.8%, up from 44.5% [9][15] - The company reported a net loss of $9.6 million for Q2 2025, a significant improvement compared to a net loss of $28.2 million in the same period of the previous year [9][15] - Adjusted EBITDA for Q2 2025 was a loss of $3.8 million, compared to a loss of $2.6 million in Q2 2024 [9][18] Market Access and Growth Strategy - Elutia's distribution strategy includes a partnership with Boston Scientific and a focus on expanding access through national GPO contracts and VAC approvals [2][4] - The company regained direct control of its cardiovascular product sales, generating $736K in revenue in the first partial quarter of direct sales [6] Litigation and Financial Position - Elutia has resolved 97 out of 110 cases related to FiberCel litigation, significantly reducing expected litigation expenses [6] - As of June 30, 2025, the company had a cash balance of $8.5 million, down from $13.2 million a year earlier [9][13]

Core Insights - Elutia Inc. reported strong first-quarter results for 2025, highlighting the successful launch and adoption of its EluPro™ product, which has established itself as a significant solution for cardiac implantable electronic device (CIED) procedures [1][4]. Business Highlights - EluPro experienced an 84% sequential sales increase, contributing to a 31% year-over-year growth in BioEnvelope revenue, totaling $3.1 million, with EluPro accounting for approximately 52% of BioEnvelope sales [4][5]. - The partnership with Boston Scientific is expected to enhance the adoption of EluPro, with over 900 sales professionals involved and initial training completed, leading to sales generation in over 50 hospitals [3][4]. - EluPro's marketing efforts include a prominent presence at the Heart Rhythm Society 2025 and a new national campaign aimed at increasing awareness [4]. - EluPro received a 2025 Edison Award for innovation, and new peer-reviewed data has validated its antibacterial efficacy [4]. Financial Performance - Total net sales decreased by 10% to $6.0 million compared to $6.7 million in Q1 2024, with BioEnvelope products showing a 31% increase [5][9]. - Gross margin on a GAAP basis was 40.7%, down from 42.5%, while adjusted gross margin was 54.8%, slightly down from 55.2% [9][17]. - The company reported a loss from operations of $7.9 million, an improvement from a loss of $8.5 million in the previous year [9][16]. Strategic Developments - Elutia regained full commercial rights to its ProxiCor™, Tyke™, and VasCure™ products, which are now sold through a contractor-based model expected to enhance cash flow [4]. - The company raised $15 million through a registered direct offering and amended loan terms to improve financial flexibility [4].