Full Press Release Details
Elutia Delivers Robust Growth on the Strength
of EluPro Market Adoption
EluPro Q2 revenue up 49% sequentially;
Elutia advances next-generation drug-eluting biomatrix for breast reconstruction
Conference call today at 5:00 p.m. ET / 2:00
GAITHERSBURG, Md., August 14, 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 second quarter of 2025. Since full launch in January 2025, EluPro has rapidly established
itself as the preferred antibiotic bioenvelope choice in cardiac implantable electronic device procedures, delivering robust revenue growth
and expanding access through national group purchasing organization (GPO) contracts, value analysis committee (VAC) approvals, and a strategic
distribution partnership with Boston Scientific. The Company also advanced its next-generation drug-eluting biomatrix pipeline, featuring
the NXT-41 platform for breast reconstruction with initial product launch planned for the second half of 2026.
Business Highlights:
| Robust Market Access of EluPro : VAC approvals now more than 160 centers, averaging about 12 new approvals monthly; customer base has grown more than 15x since launch. | ||
| Strong Clinical Demand : EluPro customers are delivering meaningfully higher value than our legacy BioEnvelope platform, CanGaroo. In the second quarter, average sales per EluPro customer were 130% higher than for CanGaroo customers, reflecting stronger procedure penetration. | ||
| Efficient Selling Model : Strong demand across both direct and distributor channels, fueling rapid market adoption and efficient entry into new geographies. Distributor-led growth now accounts for approximately 33% of EluPro sales. |
"EluPro's performance continues to
exceed expectations, and we now believe BioEnvelope sales will be approaching a $20 million annualized run rate by year-end," said
Dr. Randy Mills, CEO of Elutia. "Since its launch earlier this year, EluPro has expanded into more than 160 VAC-approved hospitals,
with our commercial team rapidly growing its nationwide footprint. On the business development front, we are evaluating multiple transactions
and expect to share more soon. With our first drug-eluting biologic proving to be a commercial success, we are rapidly advancing our NXT-41
platform, our next-generation antibiotic biomatrix for breast reconstruction. With FDA clearance of the base matrix expected in 2H26 and
the drug-eluting version in 1H27, we are targeting a $1.5 billion market where one in three patients faces serious complications, and
where NXT-41x can set a new standard of care so patients can thrive without compromise."
Second Quarter 2025 Financial Results
For the three-month period ended June 30, 2025,
as compared to the same period of 2024:
Elutia will host a conference call today at 5:00
p.m. Eastern Time / 2:00 p.m. Pacific Time to discuss its second quarter 2025 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: 13754773
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.
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 stock-based compensation,
FiberCel and VBM litigation costs, loss or gain on revaluation of warrant liability, warrant issuance expenses and loss or 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 market reception of EluPro, including the timing and
anticipated success thereof, expectations regarding the Company's next-generation drug-eluting biomatrix pipeline, including anticipated
FDA clearance and the timing and anticipated success thereof, the size of the breast reduction market and the potential of the Company's
next-generation drug-eluting biomatrix pipeline to compete in that market, and any statements regarding future liability with respect
to the FiberCel litigation. 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 continue as a going concern; our ability to successfully commercialize,
market and sell our EluPro product; our ability to obtain regulatory approval or other marketing authorizations by the FDA and comparable
foreign authorities for our products and product candidates, including our next-generation drug-eluting biomatrix pipeline; our ability
to raise capital in the amounts and at the times needed, and on acceptable terms; our ability to manage our substantial indebtedness and
other obligations, such as our revenue interest obligation to Ligand Pharmaceuticals, including our ability to negotiate waivers or similar
accommodations as needed; 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, 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)
| June 30, 2025 | December 31, 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash | $ | 8,500 | $ | 13,239 | ||||
| Accounts receivable, net | 3,150 | 2,276 | ||||||
| Inventory | 5,243 | 3,911 | ||||||
| Receivables of litigation costs | 4,297 | 4,760 | ||||||
| Prepaid expense and other current assets | 1,090 | 1,986 | ||||||
| Total current assets | 22,280 | 26,172 | ||||||
| Property and equipment, net | 2,071 | 773 | ||||||
| Intangible assets, net | 6,575 | 8,273 | ||||||
| Operating lease right-of-use assets, and other | 2,923 | 909 | ||||||
| Total assets | $ | 33,849 | $ | 36,127 | ||||
| Liabilities and Stockholders' Deficit | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses and other current liabilities | $ | 12,378 | $ | 11,253 | ||||
| Current portion of long-term debt | 3,750 | 1,250 | ||||||
| Current portion of revenue interest obligation | 4,400 | 4,400 | ||||||
| Contingent liability for legal proceedings | 17,015 | 20,432 | ||||||
| Current operating lease liabilities | 405 | 460 | ||||||
| Total current liabilities | 37,948 | 37,795 | ||||||
| Long-term debt | 21,370 | 22,603 | ||||||
| Long-term revenue interest obligation | 4,692 | 5,490 | ||||||
| Warrant liability | 8,966 | 16,076 | ||||||
| Other long-term liabilities | 2,716 | 423 | ||||||
| Total liabilities | 75,692 | 82,387 | ||||||
| Stockholders' equity (deficit): | ||||||||
| Common stock | 42 | 35 | ||||||
| Additional paid-in capital | 201,251 | 183,298 | ||||||
| Accumulated deficit | (243,136 | ) | (229,593 | ) | ||||
| Total stockholders' deficit | (41,843 | ) | (46,260 | ) | ||||
| Total liabilities and stockholders' deficit | $ | 33,849 | $ | 36,127 |