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Elutia Announces Second Quarter 2024 Results Launch Production of EluPro Underway, Commercial Team Expansion Continues, Financial Position Solidified

Key Takeaway: Elutia Inc. has announced its second quarter 2024 results, highlighting the FDA clearance of EluPro, an antibiotic-eluting BioEnvelope. The company has begun manufacturing EluPro, which is expected to have a significant impact on the market for implantable electronic devices. Financially, Elutia reported a significant net loss of $28.2 million, partly due to a non-cash charge, although they have solidified their financial position with new capital. The commercial team is expanding to ensure the successful launch and growth of both EluPro and SimpliDerm products.

Market Sentiment Analysis

POSITIVE FACTORS

  • FDA clearance obtained for the innovative EluPro product.
  • Strong financial support with $29.0 million raised through offerings.
  • Positive industry reception from partners and healthcare providers.
  • Successful expansion of commercial teams to enhance outreach.

CONCERNS & RISKS

  • Net loss increased significantly to $28.2 million.
  • Operating expenses rose to $11.3 million, indicating higher costs.

Full Press Release Details

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 protecting patients with implantable electronic devices, including pacemakers, defibrillators, and neuromodulation devices.
Completed a successful FDA inspection of the EluPro and CanGaroo manufacturing facility in Roswell, GA.
Commenced manufacturing of EluPro ahead of commercial launch.
Received enthusiastic responses from potential industry partners, treating physicians and hospital purchasing organizations regarding EluPro's availability.
Strengthened the balance sheet with approximately $29.0 million in gross proceeds from a registered direct offering and exercise of warrants.
Appointed industry veteran Ryan Marques, Ph.D., MBA, as Vice President of Operations.
Initiated the expansion of commercial teams for both EluPro and SimpliDerm.
"With the FDA clearance of EluPro, we are
equipped with what we believe is a superior product, which is bringing us significant attention from a range of participants in the multi-billion-dollar
pacemaker and defibrillator market," said Dr. Randy Mills, Elutia's Chief Executive Officer. "Additionally, our
manufacturing and quality systems were evaluated by the FDA with no deficiencies noted, clearing the way for commercial production of
EluPro. Simultaneously, we have initiated the value analysis committee submission process, all in a coordinated effort to ensure this
revolutionary product reaches our surgeon partners, enabling them to provide the best care for their patients."
Dr. Mills continued, "With a robust
financial position, we are laser focused on the successful launch of EluPro and further expanding our commercial footprint. We are systematically
building our commercial teams for both EluPro and SimpliDerm and intensifying business development efforts to extend the reach of our
drug-eluting biomatrix technology into adjacent markets covered under the EluPro approval. I want to thank our incredible team, who did
a beautiful job executing on our plan to maximize the value of Elutia for all stakeholders."
Second Quarter 2024 Financial Results
For the three-month period ended June 30,
2024, as compared to the same period of 2023:
Overall net sales were essentially unchanged at $6.3 million.
Net sales of CanGaroo increased 19% to $2.6 million, compared to $2.2 million.
Net sales of SimpliDerm increased 7% to $2.6 million, compared to $2.4 million.
Net sales of Cardiovascular products were $1.1 million, a decrease of 38%, reflecting the start of the Company's exclusive distribution relationship with LeMaitre Vascular in April 2023.
Gross margin on a GAAP basis was 45%, compared to 43%. The year-over-year increase was primarily due to rectifying non-production issues in the SimpliDerm product line.
Adjusted gross margin (a non-GAAP measure which excludes non-cash amortization of intangibles) was 58%, compared to 56%.
Total operating expenses were $11.3 million, compared to $9.0 million. The increase included higher general and administrative, sales and marketing and research and development expenses.
Loss from operations was $8.5 million, compared to $6.3 million.
Net loss was $28.2 million, compared to a net loss of $10.6 million. The increased net loss was primarily due to an $18.3 million non-cash charge in the second quarter of 2024 related to the revaluation of the Company's liability on warrants and pre-funded warrants related to the Company's September 2023 private placement financing.
Adjusted EBITDA (a non-GAAP measure that excludes from net loss certain non-operating, non-cash and non-recurring items) was a loss of $2.9 million, compared to a loss of $3.4 million. A reconciliation of net loss to adjusted EBITDA is included in the accompanying financial tables.
Cash balance as of June 30, 2024, was $18.2 million and does not reflect approximately $13.8 million in proceeds received from the exercise of outstanding warrants following the end of the quarter.
Elutia will host a conference call today at 4:30
p.m. Eastern Time / 1:30 p.m. Pacific Time to discuss its second quarter 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: 13747696
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,
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 on revaluation of warranty 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 our future interactions with the U.S. Food and Drug Administration
("FDA"); preparations for the launch of EluPro, including the timing and anticipated success thereof; the size of the pacemaker
and implantable defibrillator protection market and the potential of EluPro to compete in that market; and the potential for applying
our drug-eluting biomatrix technology into adjacent markets. 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 obtain regulatory
approval or other marketing authorizations by the FDA and comparable foreign authorities for our products and product candidates; our
ability to continue as a going concern; 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 achieve or sustain profitability;
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; the
continued and future acceptance of our products by the medical community; 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 could adversely affect our sales and profitability;
and 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, 2023, 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.
ELUTIA INC.
CONSOLIDATED BALANCE SHEET DATA
(Unaudited, in thousands)
June 30, 2024 December 31, 2023
Assets
Current assets:
Cash $ 18,188 $ 19,276
Accounts receivable, net 3,518 3,263
Inventory 3,115 3,853
Receivables of litigation costs 4,421 2,696
Prepaid expense and other current assets 1,109 2,165
Total current assets 30,351 31,253
Property and equipment, net 159 172
Intangible assets, net 9,972 11,671
Operating lease right-of-use assets, and other 1,422 332
Total assets $ 41,904 $ 43,428
Liabilities and Stockholders' Deficit
Current liabilities:
Accounts payable and accrued expenses and other current liabilities $ 11,273 $ 12,676
Current portion of long-term debt 3,449 3,321
Current portion of revenue interest obligation 4,400 11,741
Contingent liability for legal proceedings 20,198 15,024
Current operating lease liabilities 488 275
Total current liabilities 39,808 43,037
Long-term debt 18,873 20,356
Long-term revenue interest obligation 6,972 5,360
Warrant liability 39,018 12,760
Other long-term liabilities 1,571 515
Total liabilities 106,242 82,028
Stockholders' equity (deficit):
Common stock 28 23
Additional paid-in capital 157,452 137,021
Accumulated deficit (221,818 ) (175,644 )
Total stockholders' equity (deficit) (64,338 ) (38,600 )
Total liabilities and stockholders' equity $ 41,904 $ 43,428
ELUTIA INC.
CONSOLIDATED STATEMENT OF OPERATIONS
(Unaudited, in thousands, except share and per share data)
Three months ended June 30, Six months ended June 30,
2024 2023 2024 2023
Net sales $ 6,291 $ 6,351 $ 12,985 $ 12,743
Cost of goods sold 3,492 3,637 7,343 6,655
Gross profit 2,799 2,714 5,642 6,088
Operating expenses:
Sales and marketing 3,330 3,022 6,639 7,713
General and administrative 4,689 3,861 9,745 7,381
Research and development 1,001 869 2,173 2,460
FiberCel litigation costs 2,289 1,271 4,074 3,182
Total operating expenses 11,309 9,023 22,631 20,736
Loss from operations (8,510 ) (6,309 ) (16,989 ) (14,648 )
Interest expense 1,267 1,409 2,580 2,839
Other (income) expense, net 18,594 - 26,788 -
Loss before provision of income taxes (28,371 ) (7,718 ) (46,357 ) (17,487 )
Provision for income taxes (11 ) 12 (3 ) 24
Net loss from continuing operations (28,360 ) (7,730 ) (46,354 ) (17,511 )
Income (loss) from discontinued operations 180 (2,891 ) 180 (1,084 )
Net Loss (28,180 ) (10,621 ) (46,174 ) (18,595 )
Net loss from continuing operations per share basic and diluted $ (1.14 ) $ (0.48 ) $ (1.90 ) $ (1.08 )
Net income (loss) from discontinued operations per share basic and diluted $ 0.01 $ (0.18 ) $ 0.01 $ (0.07 )
Weighted average common shares outstanding - basic and diluted 24,900,167 16,223,919 24,408,651 16,208,905
ELUTIA INC.
Non-GAAP ReconciliationS of ADJUSTED GROSS PROFIT AND ADJUSTED GROSS MARGIN
(Unaudited, in thousands, except share and per share data)
Three months ended June 30, Six months ended June 30,
2024 2023 2024 2023
Net sales $ 6,291 $ 6,351 $ 12,985 $ 12,743
Gross profit 2,799 2,714 5,642 6,088
Intangible asset amortization expense 849 849 1,699 1,699
Adjusted gross profit (Non-GAAP) $ 3,648 $ 3,563 $ 7,341 $ 7,787
Gross margin 44.5 % 42.7 % 43.5 % 47.8 %
Adjusted gross margin percentage (Non-GAAP) 58.0 % 56.1 % 56.5 % 61.1 %
ELUTIA INC.
Non-GAAP ReconciliationS of EBITDA AND ADJUSTED EBITDA
(Unaudited, in thousands, except share and per share data)
Three months ended June 30, Six months ended June 30,
2024 2023 2024 2023
Net loss $ (28,180 ) $ (10,621 ) $ (46,174 ) $ (18,595 )
Interest expense (1) 1,267 1,409 2,580 2,839
Provision (benefit) for income taxes (11 ) 12 (3 ) 24
Depreciation and amortization 862 943 1,726 1,880
Earnings before interest, taxes, depreciation and amortization ("EBITDA") (Non-GAAP) (26,062 ) (8,257 ) (41,871 ) (13,852 )
Income from discontinued operations (180 ) 2,891 (180 ) 1,084
Stock-based compensation 2,711 672 4,909 1,351
FiberCel litigation costs (2) 2,289 1,271 4,074 3,182
Loss on revaluation of warranty liability (3) 18,337 - 27,974 -
Gain on revaluation of revenue interest obligation (4) - - (1,443 ) -
Adjusted EBITDA (Non-GAAP) $ (2,905 ) $ (3,423 ) $ (6,537 ) $ (8,235 )
(1) Represents interest expense recorded on all outstanding long-term debt as well as the revenue interest obligation.
(2) Represents FiberCel litigation costs consisting primarily of legal fees and the estimated and actual costs to resolve the outstanding FiberCel litigation cases offset by the estimated amounts recoverable and recovered under insurance, indemnity and contribution agreements for such costs.
(3) Represents non-cash expense attributable to the revaluation of Common Warrants and Prefunded Warrants issued in connection with a private offering of Class A common stock on September 21, 2023.
(4) Represents the gain on the revaluation of the revenue interest obligation. At each reporting period, the value of the revenue interest obligation is re-measured based on current estimates of future payments, with changes to be recorded in the consolidated statements of operations using the catch-up method.

Frequently Asked Questions

What is EluPro designed for?

EluPro is the first antibiotic-eluting BioEnvelope for protecting patients with implantable electronic devices.

What were Elutia's Q2 2024 net sales?

Elutia reported net sales of $6.3 million for the second quarter of 2024.

Who was appointed Vice President of Operations?

Ryan Marques, Ph.D., MBA, was appointed as Vice President of Operations.

How much did Elutia raise from direct offerings?

Elutia raised approximately $29 million from direct offerings and exercise of warrants.

What was the adjusted EBITDA for Q2 2024?

Elutia reported an adjusted EBITDA loss of $2.9 million for the second quarter of 2024.

Last updated: Aug 7, 2024