Elutia Conference Call Summary Company Overview - **Company**: Elutia (NasdaqCM:ELUT) - **Industry**: Biologics and Medical Devices - **Mission**: Humanizing medicine to enable patients to thrive without compromise, focusing on biologics that regenerate human tissue [2][3] Key Products and Innovations - **EluPro**: - First product combining biological matrices with antibiotics (rifampin and minocycline) to prevent postoperative infections in pacemaker implantation - Launched in January 2025, achieved $18 million run rate in nine months, sold to Boston Scientific for $88 million [4][6] - **NXT-41**: - New product targeting breast cancer patients undergoing mastectomy and reconstruction - Utilizes the same biological matrix and antibiotics as EluPro, addressing serious complications and unmet medical needs in breast reconstruction [5][7] Market Opportunity - **Breast Reconstruction Market**: - Valued at $1.5 billion with 162,000 procedures performed annually in the U.S. - High infection rates (15%-20%) lead to significant complications and costs, averaging $48,000 to fix complications due to infections [10][12][13] - **Current Solutions**: - Existing biological meshes are expensive ($7,500-$9,500) and do not effectively prevent infections, leading to poor outcomes [11][12] Competitive Advantage - **First-Mover Advantage**: - Elutia aims to establish a standard of care in the breast reconstruction market with no current competitors [37][40] - **Validated Technology**: - Proven success with EluPro and a strong team with extensive experience in FDA approvals and commercialization [34][44] Development and Regulatory Pathway - **Regulatory Strategy**: - NXT-41 is under a straightforward 510(k) pathway, while NXT-41x (drug-eluting version) will follow after NXT-41 approval, expected in the second half of 2026 [33][39] Financial Position - **Funding**: - $44 million on the balance sheet, allowing for continued development without additional dilution [35] Conclusion and Investment Proposition - **Investment Highlights**: - Strong market potential with a significant unmet medical need, validated technology, and a capable team - Current stock price is considered undervalued, presenting a potential investment opportunity [5][45]

GAITHERSBURG, Md., March 17, 2026 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix technologies, today announced that Dr. Randy Mills, Chief Executive Officer, and Matt Ferguson, PhD, Chief Financial Officer, will present and host one-on-one meetings with investors at the Sidoti Small-Cap Virtual Investor Conference, taking place March 18–19, 2026. During the presentation, management will discuss how Elutia is working to address post-surgical in ...

Financial Performance - Elutia divested its cardiac implantable electronic device (CIED) product family for an aggregate purchase price of up to $88.0 million in cash, with $80.4 million received at closing[26]. - The sale of the CIED business resulted in a net gain of $76.1 million for Elutia in 2025[32]. - The company reported losses from continuing operations of $26.9 million and $30.7 million for the years ended December 31, 2025, and 2024, respectively[139]. - The company completed the sale of its cardiac implantable electronic device (CIED) business on October 1, 2025, which may impact future financial contributions[135]. - The sale of the Orthobiologics Business generated approximately $14.6 million, with potential additional earn-out payments of up to $20.0 million[34]. - The sale of the Orthobiologics Business to Berkeley on November 8, 2023, resulted in an initial payment of $14.6 million, with potential additional earn-out payments of up to $20.0 million based on future revenues[166]. - The indemnity holdback from the sale to Berkeley amounts to $1.5 million, which will be retained for 24 months post-transaction[166]. Product Development and Market Opportunities - Elutia's lead development programs include NXT-41 and NXT-41x, aimed at addressing complications in reconstructive procedures, with a focus on local antibiotic drug delivery[28]. - The U.S. market opportunity for Elutia's next-generation antibiotic-eluting biomatrix products is estimated at approximately $1.5 billion[42]. - EluPro, the first antibiotic-eluting biologic matrix envelope, achieved annualized revenues of approximately $19 million, with EluPro contributing about $14 million[41]. - The U.S. market opportunity for biologic matrices is estimated at $1.5 billion, accounting for over 60% of reconstruction spending[75]. - The lead development programs, NXT-41 and NXT-41x, are expected to receive FDA clearance in the second half of 2026 and mid-2027, respectively[77]. - The Cook License Agreement allows the company to use porcine SIS-ECM technologies in specified cardiovascular applications, with a supply agreement in effect until December 31, 2028[87]. Regulatory and Compliance - The company’s products are subject to extensive regulation by the FDA and other authorities, ensuring safety and effectiveness for intended uses[89]. - Medical devices are classified into three categories based on risk, with Class I devices being low-risk and usually exempt from premarket notification, while Class III devices require more rigorous PMA approval[90]. - The 510(k) clearance process typically takes three to twelve months, but may extend longer if additional information is required by the FDA[93]. - Significant modifications to a device after 510(k) clearance necessitate a new clearance or PMA approval, with non-compliance potentially leading to regulatory fines[94]. - The PMA process requires extensive pre-clinical and clinical data, with FDA having 180 days for review, often extending beyond that[95]. - Clinical studies must adhere to FDA's IDE regulations, requiring approval from an Institutional Review Board (IRB) before commencing human trials[98]. - Regulatory compliance failures could lead to enforcement actions, impacting the company's ability to manufacture and sell products effectively[211]. Market Challenges and Competition - Approximately 15 to 20 percent of surgical site infections occur in certain settings, highlighting the unmet medical need for improved solutions[37]. - SimpliDerm competes against products like AbbVie's AlloDerm and various synthetic mesh products, with significant competition in the soft tissue repair market[63]. - Competitive pressures from other companies with greater resources and established products could hinder the company's market penetration and profitability[185]. - Pricing pressures from cost-containment efforts by customers and third-party payors may adversely affect sales and profitability[189]. - The healthcare industry is experiencing consolidation, which may exert downward pressure on product prices and affect the company's financial performance[193]. - The reimbursement landscape for the company's products is complex, with variations in coverage and reimbursement policies among U.S. payors[118]. - The healthcare industry trend towards cost containment may impact the company's ability to sell products profitably if reimbursement levels decrease[206]. Operational Risks - The company faces ongoing litigation related to the FiberCel and VBM recalls, with 110 separate lawsuits or claims received since September 2021[143]. - The company has recorded a total estimated contingent liability of $11.2 million related to the resolution of lawsuits from the FiberCel and VBM recalls[141]. - As of December 31, 2025, the company has no insurance coverage for the FiberCel recall liability, which may adversely affect its cash flow and financial position[142]. - The company may struggle to pass on cost increases to customers, potentially leading to lower margins and profitability[198]. - Warranty claims and product recalls could result in significant costs and negatively affect the company's financial condition[207][212]. - The company relies on a limited number of suppliers, which poses risks of significant product development costs and delivery delays if any key supplier is lost[168]. - The current volatility in capital and credit markets could impede the company's access to financing, potentially leading to deferred capital expenditures[160]. - The company may face challenges in maintaining adequate product liability insurance coverage, which could expose it to significant liabilities[149]. - Increased prices for raw materials and supplies could negatively impact the company's profitability and financial condition[196][197]. - Inaccurate demand forecasting and inventory management could result in lost sales and decreased margins, adversely affecting financial results[199]. - The company faces risks of inventory obsolescence due to the shelf life of products, which could lead to material adverse effects on profitability[200]. Human Resources and Cybersecurity - The company has 26 employees as of December 31, 2025, with 25 employed full-time, indicating a stable workforce[126]. - Company faces increasing risks from cyberattacks, with sophisticated groups targeting sensitive data and IT systems[218]. - Potential financial impacts from unauthorized access or data breaches could lead to legal claims and damage to reputation[221]. - Company may experience challenges in attracting and retaining skilled personnel due to intense competition in the healthcare industry[224]. - Cybersecurity insurance may not cover all claims, which could adversely affect financial condition if significant claims arise[223]. - The evolving nature of cyber threats complicates prevention and detection efforts, increasing operational risks[218]. - Retaining key management personnel is essential for navigating business challenges and achieving growth objectives[224].

Core Viewpoint - Elutia Inc. has granted equity awards to three new employees as part of its 2026 Inducement Award Plan, which is in compliance with Nasdaq Listing Rule 5635(c)(4) [1][2]. Group 1: Equity Awards - The three new employees received a total of 460,000 non-qualified stock options [2]. - The options vest 25% on the first anniversary of the vesting commencement date, with the remaining balance vesting in equal monthly installments over the next three years, contingent on continued employment [2]. - The exercise price for the options is set at $1.09 per share, which reflects the closing price of Elutia's common stock on the grant date [2]. Group 2: Company Overview - Elutia specializes in developing and commercializing drug-eluting biomatrix products aimed at enhancing compatibility between medical devices and patients [3]. - The company is focused on addressing the needs of a growing population requiring implantable technologies, with a mission to humanize medicine for better patient outcomes [3].

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]

Core Viewpoint - Elutia Inc. has regained compliance with Nasdaq listing requirements, allowing its Class A common stock to continue trading on the Nasdaq Capital Market under the symbol "ELUT" [1]. Group 1: Compliance and Market Position - Elutia has received notice from Nasdaq confirming compliance with the minimum bid price and market value requirements [1]. - The company views the recent increase in share price and market value as a reflection of investor confidence in its drug-eluting biomatrix technology platform and the market opportunity it addresses [1]. Group 2: Company Overview - Elutia develops and commercializes drug-eluting biomatrix products aimed at improving compatibility between medical devices and patients [2]. - The company's mission focuses on humanizing medicine to ensure patients can thrive without compromise, addressing the growing need for implantable technologies [2].

Core Insights - Elutia Inc. has appointed Pete Ligotti as Chief Commercial Officer to lead the commercialization of NXT-41x, a next-generation antibiotic-eluting biomatrix aimed at improving outcomes in plastic and reconstructive surgery [1][3] Company Overview - Elutia is focused on developing drug-eluting biomatrix products to enhance compatibility between medical devices and patients, with a mission to humanize medicine [7] Product Details - NXT-41x is built on Elutia's validated drug-eluting platform and targets the plastic and reconstructive surgery market, particularly breast reconstruction, which has over 162,000 procedures annually in the U.S. [2] - The breast reconstruction market represents an estimated $1.5 billion total opportunity in the U.S., with infection rates in current procedures ranging from 15% to 20% [2] Market Strategy - The company anticipates FDA clearance for NXT-41x in 2027 and aims to prepare a disciplined market-penetration and reimbursement strategy to replace legacy biologic mesh products [4] - The focus is on addressing the high failure rates of existing biologics in breast cancer surgery [4] Leadership Background - Pete Ligotti brings 20 years of experience in commercial execution within complex surgical markets, having previously built Integra LifeSciences' commercial operation in plastic and reconstructive surgery [3] - Ligotti has a proven track record, including scaling a specialty surgical business to over $180 million in revenue in Europe and leading a successful turnaround at NuVasive with 40% revenue growth [3]