[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 ...

Core Insights - Elutia Inc. announced the successful preclinical data publication for EluPro, the first antibiotic-eluting biologic envelope cleared by the FDA, demonstrating its effectiveness in eradicating bacteria associated with cardiovascular implantable electronic devices (CIEDs) [1][4] - EluPro has received FDA clearance for use with CIEDs and additional devices, with the first patient implant completed in September 2024, and a commercial launch planned for January 2025 [2][4] Group 1: Product Efficacy - EluPro significantly reduced bacterial colonization in an established rabbit model, achieving complete eradication of methicillin-resistant staphylococcus aureus (MRSA) and other strains, with no signs of infection in animals receiving EluPro [3] - The product demonstrated sustained local antibiotic release for over a week with minimal systemic exposure, highlighting the advantages of local drug delivery [3] Group 2: Clinical and Regulatory Milestones - The FDA clearance for EluPro includes its use with neuromodulators and neurostimulators for various medical conditions, indicating a broad application potential [2] - The first human implant of EluPro marks a significant milestone for the company, paving the way for its upcoming commercial launch [4] Group 3: Expert Endorsements - Experts, including Dr. M. Rizwan Sohail, emphasize EluPro's potential to improve implant stability, reduce device migration, and minimize scarring and fibrosis, which could facilitate easier reoperations [3] - Michelle LeRoux Williams, Elutia's Chief Scientific Officer, reinforced the product's role in enhancing infection control for CIED procedures, marking a significant advancement in implantable device protection [4]

Company Thanks Stakeholders and Employees for a Year of Remarkable Growth and Accomplishment SILVER SPRING, Md., Sept. 06, 2024 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) ("Elutia"), a pioneer in drug-eluting biomatrix products, is celebrating its one-year anniversary and the team that made it possible. On September 6, 2023, as part of a strategic shift toward drug-eluting biologics, the company rebranded as Elutia Inc. and established the mission of "Humanizing Medicine so Patients can Thrive without C ...

SILVER SPRING, Md., Sept. 05, 2024 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) ("Elutia"), a pioneer in drug-eluting biomatrix products, today announced a landmark achievement with the first-ever patient implant of EluPro®, the world's first antibiotic-eluting biologic envelope cleared by the U.S. Food and Drug Administration (FDA). The groundbreaking procedure was performed by John Catanzaro, MD, MBA, Chief, Division of Cardiology, Director, Cardiology Services, and Program Director of Clinical Cardiac ...

SILVER SPRING, Md., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) ("Elutia"), a pioneer in drug-eluting biomatrix products, today announced that Dr. Randy Mills, President and Chief Executive Officer, and Matt Ferguson, Chief Financial Officer, will participate in the following upcoming investor conferences in New York: H.C. Wainwright 26th Annual Global Investment Conference Format: Presentation and 1x1 Meetings Presentation Date and Time (On-demand beginning): Monday, September 9, 2024, 7: ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | --- | --- | |--------------------------------------------------|---------------------------------------------------------------------------------------------- ...

2nd Quarter 2024 Financial Results Call C. Randal Mills PhD Chief Executive Officer Matt Ferguson Chief Financial Officer August 7, 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 market potential ...

Elutia Inc. (NASDAQ:ELUT) Q2 2024 Earnings Conference Call August 7, 2024 4:30 PM ET Company Participants Matt Steinberg - Finn Partners, IR Randy Mills - President and CEO Matt Ferguson - Chief Financial Officer Conference Call Participants Matthew Park - Cantor Fitzgerald Frank Takkinen - Lake Street Capital Markets Operator Greetings. Welcome to the Elutia Second Quarter 2024 Financial Results Call. At this time, all participants are in listen-only mode. The question-and-answer session will follow the fo ...

Exhibit 99.1 Elutia Announces Second Quarter 2024 Results Launch Production of EluPro Underway, Commercial Team Expansion Continues, Financial Position Solidified SILVER SPRING, Md., August 7, 2024 — Elutia Inc. (Nasdaq: ELUT) ("Elutia" or the "Company"), a pioneer in drug-eluting biomatrix products, today provided a business update and financial results for the second quarter ended June 30, 2024. Business Highlights: · Received FDA clearance for EluPro, the first antibiotic-eluting BioEnvelope for protecti ...