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 ...

[Executive Summary](index=1&type=section&id=Executive%20Summary) Elutia reported strong Q3 2024 results, with initial EluPro adoption and SimpliDerm growth contributing to $1.3 million net income from continuing operations [Q3 2024 Performance Overview](index=1&type=section&id=Q3%202024%20Performance%20Overview) Elutia's Q3 2024 performance saw initial EluPro adoption and SimpliDerm growth, resulting in $1.3 million net income from continuing operations despite a slight sales decline - EluPro achieved its first patient implant and demonstrated strong initial adoption, now accounting for **25%** of BioEnvelope sales[2](index=2&type=chunk) - Over **100** EluPro VAC submissions have been made, with **36** accounts actively ordering[3](index=3&type=chunk) - SimpliDerm net sales increased **19%** to **$3.1 million**[8](index=8&type=chunk) - CEO Dr. Randy Mills highlighted the first implant of EluPro as a pivotal advancement and expressed excitement for the full commercial launch in January 2025, driven by strong initial market interest and clinical adoption[6](index=6&type=chunk) [Business Highlights](index=1&type=section&id=Business%20Highlights) Elutia's business highlights include successful initial EluPro commercialization, strategic market expansion, and ongoing clinical development efforts [EluPro Commercialization and Adoption](index=1&type=section&id=EluPro%20Commercialization%20and%20Adoption) EluPro achieved its first patient implant and strong initial adoption, now comprising 25% of BioEnvelope sales, with over 100 VAC submissions and 36 active ordering accounts - Announced the first patient implant of EluPro, the FDA-cleared antibiotic-eluting biologic envelope for pacemakers and neurostimulators[2](index=2&type=chunk) - EluPro is being utilized across all major cardiac implantable electronic device (CIED) brands and in neurostimulation procedures, now accounting for **25%** of BioEnvelope (CanGaroo and EluPro) sales[2](index=2&type=chunk) - EluPro has been submitted to over **100** hospital system value analysis committees (VACs), with **36** accounts actively ordering[3](index=3&type=chunk) [Market Expansion and Clinical Development](index=1&type=section&id=Market%20Expansion%20and%20Clinical%20Development) Elutia expanded its sales team, advanced GPO discussions for EluPro's national availability by early 2025, initiated a multi-center clinical study, and published supporting peer-reviewed data - Strengthened sales team in key markets, now including **12** direct reps, **34** independent reps, and **9** product consultants[3](index=3&type=chunk) - Advanced discussions with major group purchasing organizations (GPOs), including private health systems and the Veterans Administration (VA), anticipating favorable coverage decisions by **early 2025** to expand EluPro's national availability[4](index=4&type=chunk) - Initiated a multi-center registry study to evaluate outcomes of patients receiving EluPro during cardiac implantable electronic device (CIED) implantation[4](index=4&type=chunk) - Data published in Frontiers in Drug Delivery journal showcasing EluPro's effectiveness in eradicating bacteria linked to CIED infections, with additional manuscripts under review[5](index=5&type=chunk) - Engaged in active discussions with multiple parties exploring opportunities for EluPro[5](index=5&type=chunk) [Third Quarter 2024 Financial Results](index=1&type=section&id=Third%20Quarter%202024%20Financial%20Results) Elutia's Q3 2024 financial results show a slight net sales decrease, stable gross margin, increased operating expenses, and a net income improvement driven by non-cash gains [Net Sales Performance](index=1&type=section&id=Net%20Sales%20Performance) Overall net sales decreased 3.3% to $5.9 million in Q3 2024, with BioEnvelope sales down 12% to $2.3 million, offset by SimpliDerm's 19% growth to $3.1 million Overall Net Sales (Q3 2024 vs Q3 2023) | Metric | Q3 2024 ($M) | Q3 2023 ($M) | Change (%) | | :----- | :----------- | :----------- | :--------- | | Net Sales | 5.9 | 6.1 | -3.3% | Product Category Net Sales (Q3 2024 vs Q3 2023) | Product Category | Q3 2024 ($M) | Q3 2023 ($M) | Change (%) | | :--------------- | :----------- | :----------- | :--------- | | BioEnvelope | 2.3 | 2.6 | -12% | | SimpliDerm | 3.1 | 2.6 | +19% | | Cardiovascular | 0.6 | 1.0 | -40% | [Gross Margin Analysis](index=2&type=section&id=Gross%20Margin%20Analysis) Elutia maintained a GAAP gross margin of 46% in Q3 2024, with the adjusted gross margin (non-GAAP) slightly increasing to 61% from 60% in Q3 2023 - GAAP gross margin was **46%**, approximately the same from the prior year period[8](index=8&type=chunk) - Adjusted gross margin (non-GAAP) was **61%**, compared to **60%** in Q3 2023[9](index=9&type=chunk) [Operating Expenses and Profitability](index=2&type=section&id=Operating%20Expenses%20and%20Profitability) Operating expenses rose to $13.0 million in Q3 2024, yet net income from continuing operations improved to $1.3 million due to a $12.7 million non-cash warrant revaluation gain, while Adjusted EBITDA loss widened - Total operating expenses were **$13.0 million**, compared to **$10.2 million** in Q3 2023, primarily due to higher non-cash equity compensation charges[9](index=9&type=chunk) - Net income from continuing operations was **$1.3 million**, compared to a loss of **$8.5 million** in Q3 2023, primarily due to a **$12.7 million** non-cash gain related to the revaluation of warrant liability[10](index=10&type=chunk) - Adjusted EBITDA (non-GAAP) was a loss of **$2.9 million**, compared to a loss of **$1.7 million** in Q3 2023[11](index=11&type=chunk) - Loss from operations was **$10.2 million**, compared to **$7.4 million** in Q3 2023[14](index=14&type=chunk) [Cash and Liquidity](index=2&type=section&id=Cash%20and%20Liquidity) As of September 30, 2024, Elutia's cash balance was $25.7 million, including $13.8 million from warrant exercises at the quarter's start - Cash balance as of September 30, 2024, was **$25.7 million**[11](index=11&type=chunk) - The cash balance includes approximately **$13.8 million** in proceeds received from the exercise of outstanding warrants at the start of the quarter[11](index=11&type=chunk) [Company Information](index=2&type=section&id=Company%20Information) This section provides an overview of Elutia's mission and details regarding the Q3 2024 financial results conference call [About Elutia](index=2&type=section&id=About%20Elutia) Elutia develops and commercializes drug-eluting biomatrix products to enhance medical device-patient compatibility, with a mission to humanize medicine - Elutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and patients[12](index=12&type=chunk) - Elutia's mission is humanizing medicine so patients can thrive without compromise[12](index=12&type=chunk) [Conference Call Details](index=2&type=section&id=Conference%20Call%20Details) Elutia hosted a conference call on November 14, 2024, at 4:30 p.m. ET to discuss Q3 2024 financial results, with webcast and phone access - Elutia hosted a conference call on **November 14, 2024**, at **4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time**[12](index=12&type=chunk) - The conference call was to discuss its third quarter 2024 financial results and performance[12](index=12&type=chunk) - Access was provided via webcast and phone[12](index=12&type=chunk) [Non-GAAP Financial Measures](index=2&type=section&id=Non-GAAP%20Financial%20Measures) Elutia uses non-GAAP measures like EBITDA and Adjusted Gross Margin to provide supplemental insights into core operating performance, excluding non-cash and non-recurring items [Non-GAAP Disclosure Explanation](index=2&type=section&id=Non-GAAP%20Disclosure%20Explanation) Elutia uses non-GAAP measures (EBITDA, Adjusted Gross Margin) to provide supplemental investor information and analyze core operating results, excluding non-operating, non-cash, and non-recurring items, not as a GAAP substitute - The Company provides non-GAAP measures (EBITDA, adjusted EBITDA, adjusted gross margin, adjusted gross profit) to evaluate operating performance and liquidity[13](index=13&type=chunk) - Adjusted EBITDA excludes items such as income from discontinued operations, stock-based compensation, FiberCel litigation costs, gain/loss on revaluation of warrant liability, and gain on revaluation of revenue interest obligation[13](index=13&type=chunk) - Adjusted gross profit and adjusted gross margin exclude amortization of acquired intangible assets[13](index=13&type=chunk) - Non-GAAP financial information is presented for supplemental purposes only and should not be considered in isolation or as a substitute for GAAP financial information[13](index=13&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This section provides a standard disclaimer for forward-looking statements, noting they are based on management's beliefs and assumptions, subject to risks that could cause material differences in actual results - Forward-looking statements are identified by words such as "projects," "may," "will," "expects," and similar references to future periods[15](index=15&type=chunk) - These statements are based on management's beliefs and assumptions and are subject to known and unknown risks, uncertainties, and other important factors[15](index=15&type=chunk) - Key risks include the ability to successfully commercialize EluPro, achieve profitability, manage product liability claims and litigation, ensure product acceptance, compete effectively, obtain regulatory approval, and protect intellectual property rights[15](index=15&type=chunk) - Elutia expressly disclaims any obligations to publicly update any forward-looking statements, except as required by applicable law[15](index=15&type=chunk) [Financial Statements](index=4&type=section&id=Financial%20Statements) This section presents Elutia's unaudited consolidated balance sheet, statement of operations, and non-GAAP reconciliations for gross profit and EBITDA [Consolidated Balance Sheet Data](index=4&type=section&id=Consolidated%20Balance%20Sheet%20Data) As of September 30, 2024, total assets increased to $48.4 million, with cash at $25.7 million and contingent legal liability at $24.3 million, leading to total liabilities of $88.6 million and a $(40.2) million stockholders' deficit Consolidated Balance Sheet Data (Unaudited, in thousands) | Metric | Sep 30, 2024 ($K) | Dec 31, 2023 ($K) | | :------------------------------------------ | :----------- | :----------- | | **Assets** | | | | Cash | $25,741 | $19,276 | | Total current assets | $37,318 | $31,253 | | Total assets | $48,407 | $43,428 | | **Liabilities and Stockholders' Deficit** | | | | Total current liabilities | $39,678 | $43,037 | | Contingent liability for legal proceedings | $24,289 | $15,024 | | Warrant liability | $18,527 | $12,760 | | Total liabilities | $88,645 | $82,028 | | Total stockholders' deficit | $(40,238) | $(38,600) | [Consolidated Statement of Operations](index=6&type=section&id=Consolidated%20Statement%20of%20Operations) In Q3 2024, Elutia reported $5.9 million net sales and $2.7 million gross profit, achieving $1.3 million net income due to a non-cash warrant revaluation gain, contrasting with a $44.9 million net loss for the nine months Consolidated Statement of Operations (Unaudited, in thousands, except share and per share data) | Metric | Three months ended Sep 30, 2024 ($K) | Three months ended Sep 30, 2023 ($K) | Nine months ended Sep 30, 2024 ($K) | Nine months ended Sep 30, 2023 ($K) | | :--------------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Net sales | $5,922 | $6,127 | $18,907 | $18,870 | | Gross profit | $2,741 | $2,841 | $8,383 | $8,927 | | Total operating expenses | $12,971 | $10,212 | $35,602 | $30,945 | | Loss from operations | $(10,230) | $(7,371) | $(27,219) | $(22,018) | | Net income (loss) from continuing operations | $1,286 | $(8,519) | $(45,068) | $(26,027) | | Net income (loss) | $1,286 | $(9,747) | $(44,888) | $(28,342) | | Net income (loss) attributable to common stockholders per share - basic | $0.03 | $(0.57) | $(1.65) | $(1.72) | | Weighted average common shares outstanding - basic | 32,520,134 | 17,017,610 | 27,132,216 | 16,464,262 | [Non-GAAP Reconciliations of Adjusted Gross Profit and Adjusted Gross Margin](index=7&type=section&id=Non-GAAP%20Reconciliations%20of%20Adjusted%20Gross%20Profit%20and%20Adjusted%20Gross%20Margin) For Q3 2024, Elutia's adjusted gross profit was $3.6 million, with an adjusted gross margin of 60.6%, slightly up from 60.2% in Q3 2023, primarily excluding intangible asset amortization Non-GAAP Reconciliations of Adjusted Gross Profit and Adjusted Gross Margin (Unaudited, in thousands) | Metric | Three months ended Sep 30, 2024 ($K) | Three months ended Sep 30, 2023 ($K) | Nine months ended Sep 30, 2024 ($K) | Nine months ended Sep 30, 2023 ($K) | | :------------------------------------------ | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Net sales | $5,922 | $6,127 | $18,907 | $18,870 | | Gross profit | $2,741 | $2,841 | $8,383 | $8,927 | | Intangible asset amortization expense | $849 | $849 | $2,547 | $2,547 | | Adjusted gross profit (Non-GAAP) | $3,590 | $3,690 | $10,930 | $11,474 | | Gross margin | 46.3% | 46.4% | 44.3% | 47.3% | | Adjusted gross margin percentage (Non-GAAP) | 60.6% | 60.2% | 57.8% | 60.8% | [Non-GAAP Reconciliations of EBITDA and Adjusted EBITDA](index=7&type=section&id=Non-GAAP%20Reconciliations%20of%20EBITDA%20and%20Adjusted%20EBITDA) Elutia reported an Adjusted EBITDA loss of $2.9 million for Q3 2024, compared to a $1.7 million loss in Q3 2023, after adjusting net income/loss for various non-cash and non-operating items Non-GAAP Reconciliations of EBITDA and Adjusted EBITDA (Unaudited, in thousands) | Metric | Three months ended Sep 30, 2024 ($K) | Three months ended Sep 30, 2023 ($K) | Nine months ended Sep 30, 2024 ($K) | Nine months ended Sep 30, 2023 ($K) | | :--------------------------------------------------------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Net income (loss) | $1,286 | $(9,747) | $(44,888) | $(28,342) | | EBITDA (Non-GAAP) | $3,285 | $(7,345) | $(38,586) | $(21,167) | | Adjusted EBITDA (Non-GAAP) | $(2,910) | $(1,718) | $(9,191) | $(9,899) |

SILVER SPRING, Md., Oct. 23, 2024 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) ("Elutia"), a leader in drug-eluting biomatrix products, today announced that Dr. Randy Mills, President and Chief Executive Officer, will present at the LD Micro Main Event XVII Conference in Los Angeles on Wednesday, October 30, 2024, at 2:00 p.m. PT (5:00 p.m. ET). LD Micro Main Event XVII Conference Presentation Date: Wednesday, October 30, 2024 Presentation Time: 2:00 p.m. PT (5:00 p.m. ET) Webcast: Click here Elutia manag ...