our recalled FiberCel and other viable bone matrix products and avoid a material adverse financial consequence from those lawsuits and claims; 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 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; 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.
Investors:
Matt Steinberg
FINN Partners
matt.steinberg@finnpartners.com
ELUTIA INC.
CONSOLIDATED BALANCE SHEET DATA
(Unaudited, in thousands)
Assets September 30, 2024 December 31, 2023
-------------------- ---------------------
Current assets:
Cash $ 25,741 $ 19,276
Accounts receivable, net 2,931 3,263
Inventory 3,633 3,853
Receivables of litigation
costs 4,582 2,696
Prepaid expense and other
current assets 431 2,165
Total current assets 37,318 31,253
Property and equipment, net 693 172
Intangible assets, net 9,123 11,671
Operating lease right-of-use
assets, and other 1,273 332
Total assets $ 48,407 $ 43,428
=============== ==============
Liabilities and Stockholders'
Deficit
Current liabilities:
Accounts payable and
accrued expenses and
other current
liabilities $ 10,498 $ 12,676
Current portion of
long-term debt - 3,321
Current portion of revenue
interest obligation 4,400 11,741
Contingent liability for
legal proceedings 24,289 15,024
Current operating lease
liabilities 491 275
Total current
liabilities 39,678 43,037
Long-term debt 22,641 20,356
Long-term revenue interest
obligation 6,244 5,360
Warrant liability 18,527 12,760
Other long-term liabilities 1,555 515
Total liabilities 88,645 82,028
--------------- --------------
Stockholders' equity
(deficit):
Common stock 34 23
Additional paid-in capital 180,260 137,021
Accumulated deficit (220,532) (175,644)
--------------- --------------
Total stockholders'
deficit (40,238) (38,600)
--------------- --------------
Total liabilities and
stockholders' deficit $ 48,407 $ 43,428
=============== ==============
ELUTIA INC.
CONSOLIDATED STATEMENT OF OPERATIONS
(Unaudited, in thousands, except share and per share
data)
Three months ended Nine months ended September
September 30, 30,
-------------------------- ----------------------------
2024 2023 2024 2023
Net sales $ 5,922 $ 6,127 $ 18,907 $ 18,870
Cost of goods sold 3,181 3,286 10,524 9,943
---------- ---------- ---------- ----------
Gross profit 2,741 2,841 8,383 8,927
---------- ---------- ---------- ----------
Operating
expenses:
Sales and
marketing 2,989 2,802 9,628 10,514
General and
administrative 4,521 2,757 14,266 10,137
Research and
development 778 557 2,951 3,016
FiberCel
litigation
costs 4,683 4,096 8,757 7,278
Total
operating
expenses 12,971 10,212 35,602 30,945
---------- ---------- ---------- ----------
Loss from
operations (10,230) (7,371) (27,219) (22,018)
Interest expense 1,129 1,448 3,709 4,285
Other (income)
expense, net (12,653) (312) 14,135 (312)
Income (loss)
before
provision of
income taxes 1,294 (8,507) (45,063) (25,991)
Income tax expense 8 12 5 36
---------- ---------- ---------- ----------
Net income (loss)
from continuing
operations 1,286 (8,519) (45,068) (26,027)
Income (loss) from
discontinued
operations - (1,228) 180 (2,315)
Net income (loss) 1,286 (9,747) (44,888) (28,342)
========== ========== ========== ==========
Net income (loss)
attributable to
common
stockholders per
share - basic $ 0.03 $ (0.57) $ (1.65) $ (1.72)
========== ========== ========== ==========
Net income (loss)
attributable to
common
stockholders per
share - diluted $ (0.33) $ (0.57) $ (1.65) $ (1.72)
========== ========== ========== ==========
Weighted average
common shares
outstanding -
basic 32,520,134 17,017,610 27,132,216 16,464,262
========== ========== ========== ==========
Weighted average
common shares
outstanding -
diluted 35,520,938 17,017,610 27,132,216 16,464,262
========== ========== ========== ==========
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 Nine months ended
September 30, September 30,
---------------------- -------------------------
2024 2023 2024 2023
Net sales $5,922 $6,127 $18,907 $18,870
----- ----- ------ ------ ---
Gross profit 2,741 2,841 8,383 8,927
Intangible
asset
amortization
expense 849 849 2,547 2,547
----- ----- ------ ------ ---
Adjusted gross
profit
(Non-GAAP) $3,590 $3,690 $10,930 $11,474
----- ----- ------ ------ ---
Gross margin 46.3% 46.4% 44.3% 47.3%
Adjusted gross
margin
percentage
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