Sales Performance - Overall BioEnvelope sales increased by 18%, with same-center sales rising by 65% following the commercialization of EluPro[1] - EluPro accounted for over 30% of BioEnvelope sales in the fourth quarter, indicating strong initial market uptake[4] - Net sales for BioEnvelope products, including EluPro and CanGaroo, totaled $9.9 million for the full year 2024, a 5% increase from $9.4 million in 2023[5] - Net sales of SimpliDerm increased by 12% to $11.6 million, compared to $10.3 million in 2023[5] - Net sales for Q4 2024 were $5,468 million, a decrease of 6.9% compared to $5,875 million in Q4 2023[15] Financial Performance - Net loss from continuing operations was $54.1 million for the full year 2024, compared to a loss of $41.2 million in 2023[8] - Cash balance as of December 31, 2024, was $13.2 million, following a registered direct offering that raised approximately $15 million[8] - Gross margin on a GAAP basis was 43.9% for the full year 2024, down from 44.7% in 2023[8] - Net loss for Q4 2024 was $9,061 million, compared to a net loss of $9,316 million in Q4 2023, showing a 2.7% improvement[15] Operating Expenses - Total operating expenses for the fourth quarter were $10.8 million, compared to $10.6 million in the same period of 2023[8] - Total operating expenses for Q4 2024 were $10,756 million, an increase of 1.2% from $10,631 million in Q4 2023[15] - Research and development expenses for Q4 2024 were $834 million, down 39.5% from $1,381 million in Q4 2023[15] - FiberCel litigation costs for Q4 2024 were $2,611 million, slightly down from $2,711 million in Q4 2023[15] Profitability Metrics - Adjusted EBITDA for the fourth quarter was a loss of $3.8 million, an improvement from a loss of $4.5 million in the same period of 2023[8] - Adjusted gross profit (Non-GAAP) for Q4 2024 was $3,175 million, up 6.7% from $2,975 million in Q4 2023[16] - Adjusted gross margin percentage (Non-GAAP) for Q4 2024 was 58.1%, compared to 50.6% in Q4 2023[16] - EBITDA (Non-GAAP) for Q4 2024 was $(7,126) million, a decline from $(6,922) million in Q4 2023[18] - Adjusted EBITDA (Non-GAAP) for Q4 2024 was $(3,751) million, an improvement from $(4,453) million in Q4 2023[18] Product Development - The company had 67 approved EluPro accounts by the end of 2024, averaging more than 15 new approvals per month[4] - Gross profit for Q4 2024 increased to $2,324 million, up 9.4% from $2,124 million in Q4 2023[15]

Core Viewpoint - Elutia Inc. reported strong sales growth driven by the successful pilot launch of EluPro, an FDA-cleared antibiotic-eluting biomatrix, which has gained significant traction in the market [3][4]. Business Highlights - EluPro accounted for over 30% of BioEnvelope sales in the fourth quarter, indicating robust initial market uptake [5]. - The company ended 2024 with 67 approved EluPro accounts, averaging more than 15 new approvals per month [5]. - Sales growth is supported by agreements with major national group purchasing organizations (GPOs) [5]. - Independent sales agents contributed 45% of BioEnvelope sales from EluPro, showcasing the scalability of the sales model [5]. - Elutia raised approximately $15 million in a registered direct offering, enhancing its financial position [5]. Financial Results - For the full year 2024, net sales for BioEnvelope products increased by 5% to $9.9 million compared to $9.4 million in 2023 [6]. - SimpliDerm net sales rose by 12% to $11.6 million, while cardiovascular product sales decreased by 42% to $2.9 million [6]. - Overall net sales decreased by 1.5% to $24.4 million, driven by changes in the cardiovascular sales model [6]. - Gross margin on a GAAP basis was 43.9%, down from 44.7% [6]. - Total operating expenses increased to $46.4 million from $41.6 million, with a net loss from continuing operations of $54.1 million compared to a loss of $41.2 million in 2023 [6]. Quarterly Performance - In Q4 2024, net sales for BioEnvelope products increased by 18% to $2.7 million compared to $2.3 million in Q4 2023 [10]. - SimpliDerm sales decreased by 23% to $2.3 million, while cardiovascular product sales fell by 20% to $0.5 million [10]. - Overall net sales for the quarter decreased by 7% to $5.5 million [10]. - Gross margin on a GAAP basis improved to 42.5% from 36.2% [10]. - Adjusted EBITDA for Q4 was a loss of $3.8 million, an improvement from a loss of $4.5 million in the same period last year [10].

Core Viewpoint - Elutia Inc. is set to release its fourth quarter and full year 2024 financial results on March 6, 2025, with a conference call scheduled for the same day [1]. Company Overview - Elutia specializes in developing and commercializing drug-eluting biomatrix products aimed at enhancing the compatibility of medical devices with 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]. Conference Call Details - The conference call will begin at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time on March 6, 2025 [1]. - Access information for the call includes a U.S. investor line at 877-407-8029 and an international line at 201-689-8029, with a Conference ID of 13751810 [2]. - A live and archived webcast will be available on the "Investors" section of Elutia's website [2].

Core Viewpoint - Elutia Inc. has announced a definitive agreement for a registered direct offering of shares and prefunded warrants, aiming to raise approximately $15.0 million in gross proceeds [1][2]. Group 1: Offering Details - The company will sell 5,520,000 shares of Class A common stock at a price of $2.50 per share [1]. - Additionally, 480,000 prefunded warrants will be sold at a price of $2.499 each, which are immediately exercisable at an exercise price of $0.001 [1]. - The offering is expected to close on or about February 4, 2025, subject to customary closing conditions [1]. Group 2: Use of Proceeds - Elutia intends to utilize the proceeds from the offering for working capital and other general corporate purposes [2]. Group 3: Regulatory Information - The securities are being offered under an effective shelf registration statement on Form S-3, previously filed with the SEC [3]. - The offering will be made only by means of a prospectus supplement that is part of the registration statement [3].

Core Insights - Elutia Inc. has launched EluPro™, the first FDA-cleared antibiotic-eluting biomatrix for use with cardiac implantable electronic devices (CIEDs) and neurostimulators, marking a significant innovation in the medical device industry [1][2][3] Company Overview - Elutia focuses on developing drug-eluting biomatrix products aimed at improving compatibility between medical devices and patients, with a mission to humanize medicine [5] Product Launch Details - The launch of EluPro follows a successful pilot program that demonstrated strong physician adoption and positive patient outcomes, with orders increasing over 50% post-approval by hospital value analysis committees [2][3] - EluPro combines antibiotics rifampin and minocycline with a regenerative biomatrix, addressing infection prevention and promoting healing, which is critical given the 5-7% complication rates associated with CIEDs [3] Market Context - Over 600,000 CIEDs are implanted annually in the U.S., with a market value of $600 million for CIED protection, highlighting the potential for EluPro to capture significant market share [3]

Core Insights - Elutia Inc. has entered into an agreement with Vizient to provide access to its EluPro Antibiotic Eluting BioEnvelope to Southern Strategic Sourcing Partners (S3P), which includes 993 acute care facilities [1][3] - EluPro is the first antibiotic-eluting biologic envelope approved by the FDA for use with cardiac implantable electronic devices and neurostimulators, addressing post-surgical challenges such as infection and skin erosion [2] - The partnership with S3P is a significant milestone for Elutia, marking its second major group purchasing organization (GPO) partnership ahead of EluPro's full commercial launch [3] Company Overview - Elutia develops drug-eluting biomatrix products aimed at improving compatibility between medical devices and patients, with a mission to humanize medicine [4] - The company is focused on addressing the needs of a growing population requiring implantable technologies [4]

Group 1 - Elutia Inc. (ELUT) is a notable stock in the Medical sector, currently outperforming its peers with a year-to-date gain of 83.3% compared to an average loss of 1.7% in the Medical group [4] - The Medical group consists of 1022 companies and holds a Zacks Sector Rank of 3, indicating strong performance relative to other sectors [2] - Elutia Inc. has a Zacks Rank of 2 (Buy), with its full-year earnings estimate increasing by 42.5% in the past quarter, reflecting improved analyst sentiment [3] Group 2 - Elutia Inc. is part of the Medical - Biomedical and Genetics industry, which includes 502 companies and currently ranks 67 in the Zacks Industry Rank, with the industry experiencing an average loss of 8.8% this year [6] - Adma Biologics (ADMA) is another stock in the Medical sector that has significantly outperformed, with a year-to-date return of 313.1% [4] - Investors should closely monitor Elutia Inc. and Adma Biologics for potential continued strong performance in the Medical sector [7]

3rd Quarter 2024 Financial Results Call C. Randal Mills PhD Chief Executive Officer Matt Ferguson Chief Financial Officer November 14, 2024 Forward-Looking Statements This presentation of Elutia Inc. ("Elutia," "we," "us," "our" or the "Company") (together with any other statements or information that we may make or discuss in connection herewith) contains forward-looking statements. All statements other than statements of historical facts, including but not limited to statements regarding the launch of Elu ...

Financial Data and Key Metrics Changes - Elutia reported financial results for the quarter ended September 30, 2024, with specific metrics available in the press release [2]. Business Line Data and Key Metrics Changes - Detailed performance metrics for each business line were not provided in the available content. Market Data and Key Metrics Changes - Specific market data and key metrics were not disclosed in the available content. Company Strategy and Development Direction and Industry Competition - The management emphasized the importance of forward-looking statements regarding operating trends and future financial performance, indicating a strategic focus on growth and adaptation to market conditions [3][4]. Management Comments on Operating Environment and Future Outlook - Management highlighted that forward-looking statements involve material risks and uncertainties, suggesting a cautious approach to future expectations [4][5]. Other Important Information - The company provided a reminder about the risks associated with its business, referencing the Risk Factors section of its public filings with the SEC [5]. Q&A Session All Questions and Answers - No specific questions and answers from the Q&A session were included in the available content.

Table of Contents (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period ...