Full Press Release Details
Elutia Announces Fourth Quarter and Full Year
2024 Financial Results: Strong Demand for EluPro 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 6, 2025 - 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:
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:
Fourth Quarter 2024 Financial Results
For the three-month period ended December 31,
2024, as compared to the same period of 2023:
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:
U.S. Investors: 877-407-8029
International Investors: 201-689-8029
Conference ID: 13751810
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.
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
This press release 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," "intends," "plans," "potential," "promise" or similar references
to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered
forward-looking statements, including any statements and information concerning the launch and market reception of EluPro, including the
timing and anticipated success thereof. These forward-looking statements are based on our management's beliefs and assumptions and
on information currently available to us. Such beliefs and assumptions may or may not prove to be correct. Additionally, such forward-looking
statements are subject to a number of known and unknown risks, uncertainties and other important factors that may cause our actual results,
performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the
forward-looking statements, including, but not limited to the following: our ability to successfully commercialize, market and sell our
newly approved EluPro product; our ability to continue as a going concern; our ability to achieve or sustain profitability; the risk of
product liability claims and our ability to obtain or maintain adequate product liability insurance; our ability to defend against the
various lawsuits and claims related to our recalled FiberCel and other viable bone matrix products and avoid a material adverse financial
consequence from those lawsuits and claims; our ability to prevail in lawsuits and claims seeking indemnity, contribution and insurance
coverage for FiberCel and other viable bone matrix product liabilities; the continued and future acceptance of our products by the medical
community; our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product
offerings; our dependence on our commercial partners and independent sales agents to generate a substantial portion of our net sales;
our dependence on a limited number of third-party suppliers and manufacturers, which, in certain cases are exclusive suppliers for products
essential to our business; our ability to successfully realize the anticipated benefits of the November 2023 sale of our Orthobiologics
business; physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products;
our ability to compete against other companies, most of which have longer operating histories, more established products and/or greater
resources than we do; pricing pressure as a result of cost-containment efforts of our customers, purchasing groups, third-party payors
and governmental organizations that could adversely affect our sales and profitability; our ability to obtain regulatory approval or other
marketing authorizations by the FDA and comparable foreign authorities for our products and product candidates; our ability to obtain,
maintain and adequately protect our intellectual property rights; and other important factors which can be found in the "Risk Factors"
section of Elutia's public filings with the Securities and Exchange Commission ("SEC"), including Elutia's Annual
Report on Form 10-K for the year ended December 31, 2024, as such factors may be updated from time to time in Elutia's other filings
with the SEC, including Elutia's Quarterly Reports on Form 10-Q, accessible on the SEC's website at www.sec.gov and the Investor
Relations page of Elutia's website at https://investors.elutia.com. Because forward-looking statements are inherently subject to
risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking
statement made by Elutia in this press release is based only on information currently available and speaks only as of the date on which
it is made. Except as required by applicable law, Elutia expressly disclaims any obligations to publicly update any forward-looking statements,
whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
CONSOLIDATED BALANCE SHEET DATA
(Unaudited, in thousands)
| December 31, 2024 | December 31, 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash | $ | 13,239 | $ | 19,276 | ||||
| Accounts receivable, net | 2,276 | 3,263 | ||||||
| Inventory | 3,911 | 3,853 | ||||||
| Receivables of litigation costs | 4,760 | 2,696 | ||||||
| Prepaid expense and other current assets | 1,986 | 2,165 | ||||||
| Total current assets | 26,172 | 31,253 | ||||||
| Property and equipment, net | 773 | 172 | ||||||
| Intangible assets, net | 8,273 | 11,671 | ||||||
| Operating lease right-of-use assets, and other | 909 | 332 | ||||||
| Total assets | $ | 36,127 | $ | 43,428 | ||||
| Liabilities and Stockholders' Deficit | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses and other current liabilities | $ | 11,253 | $ | 12,676 | ||||
| Current portion of long-term debt | 1,250 | 3,321 | ||||||
| Current portion of revenue interest obligation | 4,400 | 11,741 | ||||||
| Contingent liability for legal proceedings | 20,432 | 15,024 | ||||||
| Current operating lease liabilities | 460 | 275 | ||||||
| Total current liabilities | 37,795 | 43,037 | ||||||
| Long-term debt | 22,603 | 20,356 | ||||||
| Long-term revenue interest obligation | 5,490 | 5,360 | ||||||
| Warrant liability | 16,076 | 12,760 | ||||||
| Other long-term liabilities | 423 | 515 | ||||||
| Total liabilities | 82,387 | 82,028 | ||||||
| Stockholders' equity (deficit): | ||||||||
| Common stock | 35 | 23 | ||||||
| Additional paid-in capital | 183,298 | 137,021 | ||||||
| Accumulated deficit | (229,593 | ) | (175,644 | ) | ||||
| Total stockholders' deficit | (46,260 | ) | (38,600 | ) | ||||
| Total liabilities and stockholders' deficit | $ | 36,127 | $ | 43,428 |
CONSOLIDATED STATEMENT OF OPERATIONS
(Unaudited, in thousands, except share and per share data)
| Three months ended December 31, | Twelve months ended December 31, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Net sales | $ | 5,468 | $ | 5,875 | $ | 24,375 | $ | 24,745 | ||||||||
| Cost of goods sold | 3,144 | 3,751 | 13,668 | 13,692 | ||||||||||||
| Gross profit | 2,324 | 2,124 | 10,707 | 11,053 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Sales and marketing | 2,918 | 2,572 | 12,546 | 13,087 | ||||||||||||
| General and administrative | 4,393 | 3,967 | 18,659 | 14,104 | ||||||||||||
| Research and development | 834 | 1,381 | 3,785 | 4,399 | ||||||||||||
| FiberCel litigation costs | 2,611 | 2,711 | 11,368 | 9,989 | ||||||||||||
| Total operating expenses | 10,756 | 10,631 | 46,358 | 41,579 | ||||||||||||
| Loss from operations | (8,432 | ) | (8,507 | ) | (35,651 | ) | (30,526 | ) | ||||||||
| Interest expense | 1,070 | 1,511 | 4,779 | 5,796 | ||||||||||||
| Other (income) expense, net | (443 | ) | 5,211 | 13,692 | 4,899 | |||||||||||
| Income (loss) before provision of income taxes | (9,059 | ) | (15,229 | ) | (54,122 | ) | (41,221 | ) | ||||||||
| Income tax expense | 2 | (8 | ) | 7 | 28 | |||||||||||
| Net income (loss) from continuing operations | (9,061 | ) | (15,221 | ) | (54,129 | ) | (41,249 | ) | ||||||||
| Income (loss) from discontinued operations | - | 5,905 | 180 | 3,593 | ||||||||||||
| Net income (loss) | (9,061 | ) | (9,316 | ) | (53,949 | ) | (37,656 | ) | ||||||||
| Net income (loss) attributable to common stockholders per share - basic and diluted | $ | (0.26 | ) | $ | (0.40 | ) | $ | (1.86 | ) | $ | (2.07 | ) | ||||
| Weighted average common shares outstanding - basic and diluted | 34,845,672 | 23,195,190 | 29,071,113 | 18,160,822 |
NON-GAAP RECONCILIATIONS OF ADJUSTED GROSS PROFIT AND ADJUSTED GROSS MARGIN
(Unaudited, in thousands, except share and per share data)
| Three months ended December 31, | Twelve months ended December 31, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Net sales | $ | 5,468 | $ | 5,875 | $ | 24,375 | $ | 24,745 | ||||||||
| Gross profit | 2,324 | 2,124 | 10,707 | 11,053 | ||||||||||||
| Intangible asset amortization expense | 851 | 851 | 3,398 | 3,398 | ||||||||||||
| Adjusted gross profit (Non-GAAP) | $ | 3,175 | $ | 2,975 | $ | 14,105 | $ | 14,451 | ||||||||
| Gross margin | 42.5 | % | 36.2 | % | 43.9 | % | 44.7 | % | ||||||||
| Adjusted gross margin percentage (Non-GAAP) | 58.1 | % | 50.6 | % | 57.9 | % | 58.4 | % |
NON-GAAP RECONCILIATIONS OF EBITDA AND ADJUSTED EBITDA
(Unaudited, in thousands, except share and per share data)
| Three months ended December 31, | Twelve months ended December 31, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Net loss | $ | (9,061 | ) | $ | (9,316 | ) | $ | (53,949 | ) | $ | (37,656 | ) | ||||
| Interest expense (1) | 1,070 | 1,511 | 4,779 | 5,796 | ||||||||||||
| Provision (benefit) for income taxes | 2 | (8 | ) | 7 | 28 | |||||||||||
| Depreciation and amortization | 863 | 891 | 3,451 | 3,713 | ||||||||||||
| Earnings before interest, taxes, depreciation and amortization ("EBITDA") (Non-GAAP) | (7,126 | ) | (6,922 | ) | (45,712 | ) | (28,119 | ) | ||||||||
| Income (loss) from discontinued operations | - | (5,905 | ) | (180 | ) | (3,593 | ) | |||||||||
| Stock-based compensation | 1,207 | 452 | 7,891 | 2,406 | ||||||||||||
| FiberCel litigation costs (2) | 2,611 | 2,711 | 11,368 | 9,989 | ||||||||||||
| (Gain) loss on revaluation of warrant liability (3) | (443 | ) | 4,452 | 14,878 | 4,140 | |||||||||||
| Warrant issuance expenses | - | 759 | 257 | 759 | ||||||||||||
| Gain on revaluation of revenue interest obligation (4) | - | - | (1,443 | ) | - | |||||||||||
| Adjusted EBITDA (Non-GAAP) | $ | (3,751 | ) | $ | (4,453 | ) | $ | (12,941 | ) | $ | (14,418 | ) |