Elutia Announces Fourth Quarter and Full Year 2024 Financial Results: Strong Demand for EluPro$(TM)$ in Pilot Launch Sets the Stage for Full Commercial Roll-Out

-- Overall BioEnvelope sales up 18%, with same-center sales increasing 65% following EluPro commercialization --

SILVER SPRING, Md., March 06, 2025 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) ("Elutia" or the "Company"), a pioneer in drug-eluting biomatrix technologies, today provided a business update and financial results for the fourth quarter and full year ended December 31, 2024.

Business Highlights:

   -- Strong Initial Market Uptake for EluPro: Since its pilot launch in the 
      fourth quarter, EluPro has been utilized across all major cardiac 
      implantable electronic device (CIED) brands, accounting for over 30% of 
      BioEnvelope (CanGaroo and EluPro) sales in the quarter. Early adoption in 
      neurostimulator applications is also underway. 
 
   -- Robust Market Expansion: Elutia closed 2024 with 67 approved EluPro 
      accounts, averaging more than 15 new approvals per month through Value 
      Analysis Committees (VACs). The Company now has approximately 100 
      actively ordering accounts. 
 
   -- Group Purchasing Agreements: Sales growth is further supported by 
      agreements with major national group purchasing organizations (GPOs), 
      including Premier, Inc. and Southern Strategic Sourcing Partners (S3P). 
 
   -- Strong Independent Sales Agent Engagement: The mix of BioEnvelope sales 
      generated from EluPro by the Company's independent or '1099' sales agent 
      network reached 45% in the quarter, highlighting EluPro's strong value 
      proposition and the scalability of its sales model. 
 
   -- Business Development Activity: Engaged in active discussions with 
      multiple parties exploring partnering opportunities. 
 
   -- Enhanced Financial Position: Raised gross proceeds of approximately $15 
      million in a registered direct offering that closed on February 4, 2025. 

"Elutia closed out 2024 with the successful pilot launch of EluPro, the first ever FDA-cleared antibiotic-eluting biomatrix designed for use with CIEDs and neurostimulators," said Dr. Randy Mills, CEO of Elutia. "EluPro has quickly gained traction with physicians and hospital groups, and we are building on this momentum through VACs and key GPO relationships. Most importantly, EluPro is helping patients. We believe it is the most complete solution for device protection in this $600 million market."

Full Year 2024 Financial Results

For the year ended December 31, 2024, as compared to the same period of 2023:

   -- Net sales for BioEnvelope products, including both EluPro and CanGaroo, 
      increased by 5%, totaling $9.9 million compared to $9.4 million for the 
      full year 2023. 
 
   -- Net sales of SimpliDerm increased 12% to $11.6 million, compared to $10.3 
      million. 
 
   -- Net sales of Cardiovascular products were $2.9 million, a decrease of 42%, 
      as LeMaitre Vascular continues transitioning Cardiovascular products into 
      its sales strategy, in line with our exclusive distribution relationship. 
 
   -- Overall net sales decreased 1.5% to $24.4 million, compared to $24.7 
      million, driven by the change in the cardiovascular sales model. 
 
   -- Gross margin on a GAAP basis was 43.9%, compared to 44.7%. 
 
   -- Adjusted gross margin (a non-GAAP measure which excludes non-cash 
      amortization of intangibles) was 57.9%, compared to 58.4%. A 
      reconciliation of GAAP gross margin to adjusted gross margin is included 
      in the accompanying financial tables. 
 
   -- Total operating expenses were $46.4 million, compared to $41.6 million. 
 
   -- Loss from operations was $35.7 million, compared to $30.5 million. 
 
   -- Net loss from continuing operations was $54.1 million, compared to a loss 
      of $41.2 million. 
 
   -- Adjusted EBITDA (a non-GAAP measure that excludes from net loss certain 
      non-operating, non-cash and non-recurring items) was a loss of $12.9 
      million, compared to a loss of $14.4 million. A reconciliation of net 
      income (loss) to adjusted EBITDA is included in the accompanying 
      financial tables. 
 
   -- Cash balance as of December 31, 2024, was $13.2 million. Following 
      year-end, the company completed a registered direct offering resulting in 
      gross proceeds of approximately $15 million. 

Fourth Quarter 2024 Financial Results

For the three-month period ended December 31, 2024, as compared to the same period of 2023:

   -- Net sales for BioEnvelope products, including both EluPro and CanGaroo, 
      increased by 18%, totaling $2.7 million compared to $2.3 million in Q4 
      2023, reflecting strong initial sales of EluPro. 
 
   -- Net sales of SimpliDerm decreased 23% to $2.3 million, compared to $3.0 
      million. 
 
   -- Net sales of Cardiovascular products were $0.5 million, a decrease of 
      20%. 
 
   -- Overall net sales decreased 7% to $5.5 million, compared to $5.9 million. 
 
   -- Gross margin on a GAAP basis was 42.5%, compared to 36.2% 
 
   -- Adjusted gross margin (a non-GAAP measure which excludes non-cash 
      amortization of intangibles) was 58.1%, compared to 50.6%. A 
      reconciliation of GAAP gross margin to adjusted gross margin is included 
      in the accompanying financial tables. 
 
   -- Total operating expenses were $10.8 million, compared to $10.6 million. 
 
   -- Loss from operations was $8.4 million, compared to $8.5 million. 
 
   -- Net loss from continuing operations was $9.1 million, compared to a loss 
      of $15.2 million. 
 
   -- Adjusted EBITDA (a non-GAAP measure that excludes from net loss certain 
      non-operating, non-cash and non-recurring items) was a loss of $3.8 
      million, compared to a loss of $4.5 million. A reconciliation of net 
      income (loss) to adjusted EBITDA is included in the accompanying 
      financial tables. 

Conference Call

Elutia will host a conference call today at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time to discuss its fourth quarter and full year 2024 financial results and performance.

The conference call can be accessed using the following information:

Webcast: Click here

U.S. Investors: 877-407-8029

International Investors: 201-689-8029

Conference ID: 13751810

About Elutia

Elutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia's mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com.

Non-GAAP Disclosure

In addition to the Company's financial results determined in accordance with U.S. GAAP, the Company provides non-GAAP measures that it determines to be useful in evaluating its operating performance and liquidity. The Company presents in this press release the following non-GAAP financial measures: earnings before interest, taxes, depreciation and amortization ("EBITDA"), adjusted earnings before interest, taxes, depreciation and amortization ("adjusted EBITDA"), adjusted gross margin and adjusted gross profit. The Company defines EBITDA as GAAP net loss excluding interest expense, income tax expense, depreciation and amortization, and the Company defines adjusted EBITDA as EBITDA excluding income from discontinued operations, stock-based compensation, FiberCel litigation costs, loss on extinguishment of debt, net of gain on debt forgiveness, loss or gain on revaluation of warrant liability and gain on revaluation of revenue interest obligation. The Company defines adjusted gross profit and adjusted gross margin as GAAP gross profit and GAAP gross margin, respectively, excluding amortization of acquired intangible assets. The amortization of these intangible assets will recur in future periods until such intangible assets have been fully amortized. Management believes that presentation of non-GAAP financial measures provides useful supplemental information to investors and facilitates the analysis of the Company's core operating results and comparison of operating results across reporting periods. The Company uses this non-GAAP financial information to establish budgets, manage the Company's business, and set incentive and compensation arrangements. Non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental information purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with U.S. GAAP. For a reconciliation of these non-GAAP measures to GAAP, see below "Non-GAAP Reconciliations of EBITDA and Adjusted EBITDA" and "Non-GAAP Reconciliations of Adjusted Gross Profit and Adjusted Gross Margin."

Forward-Looking Statements

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March 06, 2025 16:05 ET (21:05 GMT)