Full Press Release Details
Announces First Quarter 2024 Results: SimpliDerm Sales Increase 55%,
CanGaroo RM on Track for Second Quarter 2024 FDA Clearance
Md., May 9, 2024 - Elutia Inc. (Nasdaq: ELUT) ("Elutia" or the "Company"), a company pioneering drug-eluting
biomatrix products, today provided a business update and financial results for the first quarter ended March 31, 2024.
Business Highlights:
through the regulatory process for CanGarooRM with one goal: FDA clearance in the second quarter for the world's first antibiotic-eluting
biologic envelope," stated Dr. Randy Mills, Elutia's Chief Executive Officer. "The pacemaker and implantable defibrillator
protection market is valued at $600 million and has only one legacy player offering a fully synthetic envelope. We aim to disrupt this
space with our proprietary technology that is both antimicrobial and regenerative, thereby setting a new standard for excellence in patient
Dr. Mills continued,
"Our Women's Health team is successfully executing a similar strategy with SimpliDerm, achieving robust sales growth of 55%.
This sharp sales increase spotlights the crucial role SimpliDerm plays in supporting a woman's recovery following mastectomy. I
offer my sincere thanks to the entire Elutia CRU for delivering another spectacular quarter."
Following the successful
submission of the 510(k) premarket notification to the FDA in December 2023, Elutia has been in positive, ongoing discussions with the
Agency and expects to close out any remaining inquiries within the month. As a result, the Company anticipates a positive FDA decision
by the end of June 2024.
With only one competitor
in the $600 million pacemaker and implantable defibrillator protection market, CanGarooRM represents immense potential in the drug-eluting
market. In anticipation of the pending regulatory clearance, Elutia continues to fortify its operational and commercial strength and
expects to initiate manufacturing and commercial introduction of CanGarooRM in the second half of this year.
2024 Financial Results
period ended March 31, 2024, as compared to the same period of 2023:
a conference call today at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time to discuss its first quarter 2024 financial results and performance.
call can be accessed using the following information:
U.S. Investors: 877-407-8029
International Investors: 201-689-8029
Conference ID: 13746000
Individuals interested
in listening to the conference call are required to register online. Participants are recommended to log in approximately 10 minutes
before the start of the call. A live and archived webcast of the event and the accompanying presentation materials will be available
on the "Investors" section of the Elutia website at investors.elutia.com.
develops and commercializes biologic 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.
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
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") regarding CanGarooRM; expectations for FDA clearance of CanGarooRM, including the
timing and anticipated success thereof; preparations for the launch of CanGarooRM, including the timing and anticipated success thereof;
the size of the pacemaker and implantable defibrillator protection market and the potential of CanGarooRM to compete in that market;
and our future strategy with respect to SimpliDerm. 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 related to FiberCel and VBM and avoid
a material adverse financial consequence; 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 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.
| March 31, 2024 | December 31, 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash | $ | 12,551 | $ | 19,276 | ||||
| Accounts receivable, net | 4,406 | 3,263 | ||||||
| Inventory | 3,052 | 3,853 | ||||||
| Receivables of litigation costs | 2,031 | 2,696 | ||||||
| Prepaid expense and other assets | 1,946 | 2,165 | ||||||
| Total current assets | 23,986 | 31,253 | ||||||
| Property and equipment, net | 171 | 172 | ||||||
| Intangible assets, net | 10,822 | 11,671 | ||||||
| Operating lease right-of-use assets, and other | 383 | 332 | ||||||
| Total assets | $ | 35,362 | $ | 43,428 | ||||
| Liabilities and Stockholders' Deficit | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses and other current liabilities | $ | 14,085 | $ | 12,676 | ||||
| Current portion of long-term debt and revenue interest obligation | 8,174 | 15,062 | ||||||
| Contingent liability for FiberCel litigation | 15,591 | 15,024 | ||||||
| Current operating lease liabilities | 217 | 275 | ||||||
| Total current liabilities | 38,067 | 43,037 | ||||||
| Long-term debt | 19,738 | 20,356 | ||||||
| Long-term revenue interest obligation | 7,659 | 5,360 | ||||||
| Warrant liability | 19,503 | 12,760 | ||||||
| Other long-term liabilities | 694 | 515 | ||||||
| Total liabilities | 85,661 | 82,028 | ||||||
| Stockholders' equity (deficit): | ||||||||
| Common stock | 24 | 23 | ||||||
| Additional paid-in capital | 143,315 | 137,021 | ||||||
| Accumulated deficit | (193,638 | ) | (175,644 | ) | ||||
| Total stockholders' equity (deficit) | (50,299 | ) | (38,600 | ) | ||||
| Total liabilities and stockholders' equity | $ | 35,362 | $ | 43,428 |
CONSOLIDATED STATEMENT OF OPERATIONS
(Unaudited, in thousands, except share and per share data)
| Three months ended March 31, | ||||||||
| 2024 | 2023 | |||||||
| Net sales | $ | 6,694 | $ | 6,392 | ||||
| Cost of goods sold | 3,851 | 3,018 | ||||||
| Gross profit | 2,843 | 3,374 | ||||||
| Operating expenses: | ||||||||
| Sales and marketing | 3,309 | 4,691 | ||||||
| General and administrative | 5,056 | 3,520 | ||||||
| Research and development | 1,172 | 1,591 | ||||||
| FiberCel litigation costs | 1,785 | 1,911 | ||||||
| Total operating expenses | 11,322 | 11,713 | ||||||
| Loss from continuing operations | (8,479 | ) | (8,339 | ) | ||||
| Interest expense | 1,313 | 1,430 | ||||||
| Other (income) expense, net | 8,194 | - | ||||||
| Loss before provision for income taxes | (17,986 | ) | (9,769 | ) | ||||
| Provision for income taxes | 8 | 12 | ||||||
| Net loss from continuing operations | (17,994 | ) | (9,781 | ) | ||||
| Income from discontinued operations | - | 1,807 | ||||||
| Net Loss | (17,994 | ) | (7,974 | ) | ||||
| Net loss from continuing operations per share basic and diluted | $ | (0.75 | ) | $ | (0.61 | ) | ||
| Net income (loss) from discontinued operations per share basic and diluted | $ | - | $ | 0.11 | ||||
| Weighted average common shares outstanding - basic and diluted | 23,912,326 | 16,149,567 |
Non-GAAP ReconciliationS of ADJUSTED GROSS PROFIT AND ADJUSTED GROSS MARGIN
(Unaudited, in thousands, except share and per share data)
| Three months ended March 31, | ||||||||
| 2024 | 2023 | |||||||
| Net sales | $ | 6,694 | $ | 6,392 | ||||
| Gross profit | 2,843 | 3,374 | ||||||
| Intangible asset amortization expense | 849 | 849 | ||||||
| Adjusted gross profit (non-GAAP) | $ | 3,692 | $ | 4,223 | ||||
| Gross margin | 42.5 | % | 52.8 | % | ||||
| Adjusted gross margin percentage (non-GAAP) | 55.2 | % | 66.1 | % |
Non-GAAP ReconciliationS of EBITDA AND ADJUSTED EBITDA
(Unaudited, in thousands, except share and per share data)
| Three months ended March 31, | ||||||||
| 2024 | 2023 | |||||||
| Net loss | $ | (17,994 | ) | $ | (7,974 | ) | ||
| Interest expense (1) | 1,313 | 1,430 | ||||||
| Provision for income taxes | 8 | 12 | ||||||
| Depreciation and amortization | 864 | 947 | ||||||
| Earnings before interest, taxes, depreciation and amortization ("EBITDA") (non-GAAP) | (15,809 | ) | (5,585 | ) | ||||
| Income from discontinued operations | - | (1,807 | ) | |||||
| Stock-based compensation | 2,197 | 684 | ||||||
| FiberCel litigation costs (2) | 1,785 | 1,911 | ||||||
| Loss on revaluation of warranty liability (3) | 9,637 | - | ||||||
| Gain on revaluation of revenue interest obligation (4) | (1,443 | ) | - | |||||
| Adjusted EBITDA (non-GAAP) | $ | (3,633 | ) | $ | (4,797 | ) |