Item 9A. Controls and Procedures
Item 9A. Controls and Procedures.
Limitations on Effectiveness of Controls and Procedures
In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs.
Evaluation of Disclosure Controls and Procedures
The Company’s management has evaluated, with the participation of our principal executive officer and our principal financial officer, the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this Annual Report. Based on this evaluation, management concluded that the Company’s disclosure controls and procedures were effective at the reasonable assurance level as of December 31, 2023.
Management’s Annual Report on Internal Control Over Financial Reporting
O ur management, with the participation of our principal executive officer and our principal financial officer, is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Our management conducted an assessment of the effectiveness of our internal control over financial reporting based on the criteria set forth in “Internal Control–Integrated Framework (2013)” issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this assessment, management concluded that, as of December 31, 2023, our internal control over financial reporting was effective.
Attestation Report of the Registered Public Accounting Firm
Our independent registered accounting firm will not be required to opine on the effectiveness of our internal control over financial reporting pursuant to Section 404 of Sarbanes-Oxley Act of 2002 until we are no longer an “emerging growth company” as defined in the JOBS Act.
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Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the three months and year ended December 31, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Item 9B. Other Information.
N o n e .
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not applicable.
PART III
Item 10. Directors, Executive Officers and Corporate Governance.
The information required by this Item is incorporated herein by reference to the information that will be contained in our proxy statement related to our annual meeting of stockholders to be held in 2024 (the “2024 Annual Meeting of Stockholders”), which we intend to file with the SEC within 120 days of the year ended December 31, 2023.
Item 11. Executive Compensation.
The information required by this Item is incorporated herein by reference to the information that will be contained in our proxy statement related to the 2024 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days of the year ended December 31, 2023.
Item 12. Security Ownership of Certain Beneficial Owners and Management Related Stockholder Matters.
Equity Compensation Plan Information
The following table provides information on our equity compensation plans as of December 31, 2023.
Number of
Number of securities
Securities to be
remaining available for
Issued Upon
future issuance under
Exercise of
Weighted Average
equity compensation
Outstanding
Exercise Price of
plans (excluding
Options, Warrants
Outstanding Options,
securities reflected in
and Rights
Warrants and Rights
column (a))
Plan Category
(a)
(b)
(c)
Equity Compensation Plans Approved by Stockholders
2015 Plan (1)
49,131
$
5.78
(4)
—
(5)
2020 Plan (2)
1,787,670
$
8.45
(4)
3,401,678
(5)
ESPP (3)
—
—
335,808
Equity Compensation Plans Not Approved by Stockholders
—
—
—
Total
1,836,801
$
3,737,486
(1)
In connection with our IPO, we adopted the Elutia Inc. 2020 Incentive Award Plan (the “2020 Plan”) and, as of the consummation of our IPO, ceased making grants or awards under the Elutia Inc. 2015 Stock Option/Stock Issuance Plan (the “2015 Plan”). To the extent stock options outstanding under the 2015 Plan are forfeited, lapse unexercised
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or are settled in cash, the shares of Class A common stock subject to the stock options will be available for future issuance under the 2020 Plan.
(2)
1,685,962 shares of Class A common stock were initially available for issuance under the 2020 Plan. The number of shares of Class A common stock available for issuance under the 2020 Plan automatically increases on each January 1, until and including January 1, 2030, by an amount equal to the lesser of (A) 4% of the shares of Class A common stock outstanding (on an as-converted basis) on the last day of the immediately preceding fiscal year and (B) such smaller number of shares of Class A common stock as determined by our board of directors (but no more than 1,636,000 shares of Class A common stock may be issued upon the exercise of incentive stock options). In addition, the shares reserved for issuance under the 2020 Plan will also include shares reserved but not issued under the 2015 Plan. In June 2023, the stockholders of the Company approved the amendment and restatement of the 2020 Plan which, among other things, increased the number of shares of Class A common stock reserved for issuance under the 2020 Plan by 2,000,000 shares.
(3)
The number of shares of Class A common stock available for issuance under the ESPP automatically increases on each January 1, until and including January 1, 2030, by an amount equal to the lesser of (A) 1% of the shares of Class A and Class B common stock outstanding on the last day of the immediately preceding fiscal year and (B) such smaller number of shares of Class A common stock as determined by our board of directors.
(4)
The calculation of the weighted average exercise price does not include outstanding equity awards that are received or exercised for no consideration. On January 31, 2024, the Compensation Committee of the Company’s Board of Directors approved an exchange program to reprice certain stock options granted under the 2020 Plan with exercise prices per share greater than $7.00. The exercise prices of the stock options were reduced to $3.61.
(5)
On January 31, 2024, the Company granted stock options covering 1,615,561shares of Class A common stock and restricted stock units covering 2,267,500 shares of Class A common stock to employees and consultants under the 2020 Plan. In addition to the amounts available for future issuance noted in the table above, such grants also partially utilized the increased availability from the automatic increase of 927,904 on January 1, 2024.
The other information required by this Item is incorporated herein by reference to the information that will be contained in our proxy statement related to the 2024 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days of the year ended December 31, 2023.
Item 13. Certain Relationships and Related Transactions, and Director Independence.
The information required by this Item is incorporated herein by reference to the information that will be contained in our proxy statement related to the 2024 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days of the year ended December 31, 2023.
Item 14. Principal Accountant Fees and Services.
The information required by this Item is incorporated herein by reference to the information that will be contained in our proxy statement related to the 2024 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days of the year ended December 31, 2023.
PART IV
Item 15. Exhibits and Financial Statement Schedules.
(a)(1) Financial Statements
The Consolidated Financial Statements are included on pages F-2 through F-31 attached hereto and are filed as part of this Annual Report. See Index to Consolidated Financial Statements on page F-1.
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(a)(2) Financial Statement Schedules
All financial statement schedules have been omitted because they are not applicable, not required or the information required is shown in the financial statements or the notes thereto.
(a)(3) Exhibits
The following is a list of exhibits filed as part of this Annual Report.
Exhibit Number
Description
Form
File No.
Exhibit
Filing Date
Filed/Furnished Herewith
2.1
Asset Purchase Agreement, dated September 17, 2023, by and among Elutia Inc., Berkeley Biologics, LLC, and GNI Group, Ltd. (solely with respect to Section 11.18)
8-K
001-39577
10.1
9/19/2023
3.1
Restated Certificate of Incorporation of Elutia Inc.
8-K
001-39577
3.1
10/13/2020
3.2
Amended and Restated Bylaws of Elutia Inc.
8-K
001-39577
3.2
10/13/2020
4.1
Second Amended and Restated Investor Rights Agreement, dated as of September 14, 2020, among the Registrant and the investors named therein
S-1
333-248788
4.1
09/14/2020
4.2
Specimen stock certificate evidencing the shares of Class A common stock
S-1
333-248788
4.2
09/14/2020
4.3
Specimen stock certificate evidencing the shares of Class B common stock
S-1/A
333-248788
4.3
09/30/2020
4.4
Warrant to Purchase Stock, issued on August 10, 2022, by Elutia Inc.to SWK Funding LLC.
8-K
001-39577
4.1
8/15/2022
4.5
Form of Common Warrant
8-K
001-39577
4.1
9/21/2023
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Exhibit Number
Description
Form
File No.
Exhibit
Filing Date
Filed/Furnished Herewith
4.6
Form of Prefunded Warrant
8-K
001-39577
4.2
9/21/2023
4.7
Registration Rights Agreement, dated September 21, 2023, by and among Elutia Inc. and the Investors named therein
8-K
001-39577
10.2
9/21/2023
4.8
Description of Securities
10-K
001-39577
4.4
03/15/2021
10.1
Registration Rights Agreement, dated December 5, 2021, by and among Elutia Inc. and the Investors named therein.
8-K
001-39577
10.2
12/08/2021
10.2
Royalty Agreement, dated as of May 31, 2017, by and between Elutia Med, LLC and Ligand Pharmaceuticals Incorporated
S-1
333-248788
10.15
09/14/2020
10.3
License Agreement, dated as of May 31, 2017, by and between Cook Biotech Incorporated and Elutia Med, LLC
S-1
333-248788
10.16
09/14/2020
10.4
December 2017 Amendment to License Agreement, dated as of December 21, 2017, by and between Cook Biotech Incorporated and Elutia Med, LLC
S-1
333-248788
10.17
09/14/2020
10.5†
Elutia Inc. 2015 Stock Option/Stock Issuance Plan (as amended)
S-1
333-248788
10.1
09/14/2020
10.6†
Elutia Inc. 2020 Incentive Award Plan and form of stock option agreements thereunder
10-K
001-39577
10.6
3/23/2023
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Table of Contents
Exhibit Number
Description
Form
File No.
Exhibit
Filing Date
Filed/Furnished Herewith
10.7†
Form of Restricted Stock Unit Award Agreement (approved August 2022)
10-Q
001-39577
10.4
11/14/2022
10.8†
Form of Restricted Stock Unit Award Agreement (approved October 2020)
10-K
001-39577
10.8
3/23/2023
10.9†
Elutia Inc. Non-Employee Director Compensation Program
S-1/A
333-248788
10.3
09/30/2020
10.10†
Elutia Inc. 2020 Employee Stock Purchase Plan
S-1/A
333-248788
10.4
09/30/2020
10.11†
Amended and Restated Employment Agreement, by and between the Registrant and Ronald Lloyd, dated as of September 30, 2021
S-1/A
333-248788
10.6
09/30/2020
10.12†
Separation and Release of Claims Agreement, dated June 21, 2022, by and between Ronald Lloyd and Elutia Inc.
8-K
001-39577
10.1
6/21/2022
10.13†
Employment Agreement, dated June 21, 2022, by and between C. Randal Mills, Ph.D. and Elutia Inc.
8-K
001-39577
10.2
6/21/2022
10.14†
Amended and Restated Employment Agreement, dated December 23, 2022, by and between Elutia Inc. and Thomas Englese
8-K
001-39577
10.2
12/30/2022
101
Table of Contents
Exhibit Number
Description
Form
File No.
Exhibit
Filing Date
Filed/Furnished Herewith
10.15†
Letter Agreement, dated as of March 22, 2023, by and between Elutia Inc. and Thomas Englese
10-K
001-39577
10.15
3/23/2023
10.16†
Amended and Restated Employment Agreement, dated December 23, 2022, by and between Elutia Inc. and Matthew Ferguson
8-K
001-39577
10.1
12/30/2022
10.17†
Form of Indemnification Agreement for Directors and Officers
S-1/A
333-248788
10.12
09/30/2020
10.18#
Credit Agreement, dated as of August 10, 2022, between Elutia Inc. and SWK Funding LLC, as Agent and the Lenders from time to time party thereto
8-K
001-39577
10.1
8/15/2022
10.19
Amendment Letter, dated as of October 9, 2022 to Credit Agreement, dated as of August 10, 2022, between Elutia Inc. and SWK Funding LLC, as Agent and the Lenders from time to time party thereto
8-K
001-39577
10.1
10/13/2022
10.20
Amendment Letter, dated as of November 10, 2022 to Credit Agreement, dated as of August 10, 2022, between Elutia Inc. and SWK Funding LLC, as Agent and the Lenders from time to time party thereto (as amended by the Amendment Letter dated as of October 9, 2022)
10-Q
001-39577
10.3
11/14/2022
102
Table of Contents
Exhibit Number
Description
Form
File No.
Exhibit
Filing Date
Filed/Furnished Herewith
10.21
Amendment Letter, dated as of November 21, 2022, to the Credit Agreement, dated as of August 10, 2022, among Elutia Inc., SWK Funding LLC, as Agent, and the Lenders from time to time party thereto (as amended).
8-K
001-39577
10.1
11/28/2022
10.22
Amendment Letter, dated as of November 30, 2022, to the Credit Agreement, dated as of August 10, 2022, among Elutia Inc., SWK Funding LLC, as Agent, and the Lenders from time to time party thereto (as amended).
8-K
001-39577
10.1
12/5/2022
10.23
First Amendment, dated as of May 12, 2023, to the Credit Agreement, dated August 10, 2022, by and among Aziyo Biologics, Inc., SWK Funding LLC, as Agent and the Lenders from time to time party thereto
10-Q
001-39577
10.4
5/12/2023
10.24†
Aziyo Biologics, Inc. Amended and Restated 2020 Incentive Award Plan
Proxy Statement
001-39577
Annex A
04/27/2023
10.25
Distribution Agreement by and between Aziyo Biologics, Inc. and LeMaitre Vascular, Inc.
10-Q
001-39577
10.2
8/14/2023
10.26
Securities Purchase Agreement, dated September 18, 2023, by and among Elutia Inc. and the Investors named therein.
8-K
001-39577
10.1
9/21/2023
21.1
Subsidiaries of Elutia, Inc.
10-K
001-39577
21.1
03/8/2022
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Exhibit Number
Description
Form
File No.
Exhibit
Filing Date
Filed/Furnished Herewith
23.1
Consent of PricewaterhouseCoopers LLP
*
31.1
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
*
31.2
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
*
32.1
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
**
32.2
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
**
97
Elutia Inc. Excess Incentive-based Compensation Recoupment Policy
*
104
Table of Contents
Exhibit Number
Description
Form
File No.
Exhibit
Filing Date
Filed/Furnished Herewith
101.INS
Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document
*
101.SCH
Inline XBRL Taxonomy Extension Schema Document
*
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document
*
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document
*
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document
*
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document
*
104
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
*
* Filed herewith.
** Furnished herewith.
† Denotes a management contract or compensation plan or arrangement.
# Annexes, schedules and exhibits have been omitted pursuant to Item 601(a)(5)(b)(2) of Regulation S-K. The Registrant hereby agrees to furnish supplementally a copy of any omitted annex, schedule or exhibit to the SEC upon request.
Item 16. Form 10-K Summary.
None.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Elutia Inc.
Date: March 11, 2024
By:
/s/ C. RANDAL MILLS, PH.D.
C. Randal Mills
President and Chief Executive Officer
(Principal Executive Officer)
Date: March 11, 2024
/s/ MATTHEW FERGUSON
Matthew Ferguson
Chief Financial Officer
(Principal Financial Officer and Principal
Accounting Officer)
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Report has been signed below by the following persons on behalf of the Registrant in the capacities and on the dates indicated.
Name
Title
Date
/s/C. Randal Mills, Ph.D.
President, Chief Executive Officer and Director
(principal executive officer)
March 11, 2024
C. Randal Mills
/s/Matthew Ferguson
Chief Financial Officer
(principal financial officer and principal accounting officer)
March 11, 2024
Matthew Ferguson
/s/Kevin Rakin
Chairperson of the Board of Directors
March 11, 2024
Kevin Rakin
/s/W. Matthew Zuga
Director
March 11, 2024
W. Matthew Zuga
/s/Maybelle Jordan
Director
March 11, 2024
Maybelle Jordan
/s/David Colpman
Director
March 11, 2024
David Colpman
/s/Brigid A. Makes
Director
March 11, 2024
Brigid A. Makes
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ELUTIA INC.
INDEX TO FINANCIAL STATEMENTS
Report of Independent Registered Public Accounting Firm (PCAOB ID: 238 )
F-2
Consolidated Balance Sheets
F-3
Consolidated Statements of Operations
F-4
Consolidated Statements of Changes in Stockholders’ Equity (Deficit)
F-5
Consolidated Statements of Cash Flows
F-6
Notes to Consolidated Financial Statements
F-7
F-1
Table of Contents
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders of Elutia Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Elutia Inc. and its subsidiaries (the “Company”) as of December 31, 2023 and 2022, and the related consolidated statements of operations, of changes in stockholders’ equity (deficit) and of cash flows for the years then ended, including the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and 2022, and the results of its operations and its cash flows for the years then ended in conformity with accounting principles generally accepted in the United States of America.
Substantial Doubt about the Company’s Ability to Continue as a Going Concern
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the consolidated financial statements, the Company has generated recurring losses from operations and is expected to incur cash outflows from operating activities that raise substantial doubt about its ability to continue as a going concern. Management's plans in regard to these matters are also described in Note 2. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Change in Accounting Principle
As discussed in Note 2 to the consolidated financial statements, the Company changed the manner in which it accounts for leases in 2022.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits of these consolidated financial statements in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ PricewaterhouseCoopers LLP
Philadelphia, Pennsylvania
March 11, 2024
We have served as the Company’s auditor since 2015.
F-2
Table of Contents
ELUTIA INC.
CONSOLIDATED BALANCE SHEETS
(In Thousands, Except for Share and Per Share Data)
December 31,
December 31,
2023
2022
Assets
Current assets:
Cash and cash equivalents
$
19,276
$
16,989
Accounts receivable, net
3,263
3,774
Inventory
3,853
4,240
Receivables of FiberCel litigation costs
2,696
13,813
Prepaid expenses and other current assets
2,165
2,387
Current assets of discontinued operations
—
9,496
Total current assets
31,253
50,699
Property and equipment, net
172
245
Intangible assets, net
11,671
15,069
Operating lease right-of-use assets and other
332
320
Noncurrent assets of discontinued operations
—
2,508
Total assets
$
43,428
$
68,841
Liabilities and Stockholders’ Equity (Deficit)
Current liabilities:
Accounts payable
$
2,285
$
1,374
Accrued expenses
9,485
8,830
Payables to tissue suppliers
906
900
Current portion of long-term debt
3,321
—
Current portion of revenue interest obligation
11,741
8,990
Contingent liability for FiberCel litigation
15,024
17,360
Current operating lease liabilities
275
232
Current liabilities of discontinued operations
-
4,929
Total current liabilities
43,037
42,615
Long-term debt
20,356
24,260
Long-term revenue interest obligation
5,360
5,916
Warrant liability
12,760
—
Other long-term liabilities
515
127
Noncurrent liabilities of discontinued operations
—
956
Total liabilities
82,028
73,874
Commitments and contingencies (Note 17)
Stockholders’ equity (deficit):
Class A Common stock, $ 0.001 par value, 200,000,000 shares authorized as of December 31, 2023 and December 31, 2022, and 18,884,196 and 11,823,445 shares issued and outstanding, as of December 31, 2023 and December 31, 2022, respectively
19
12
Class B Common stock, $ 0.001 par value, 20,000,000 shares authorized, as of December 31, 2023 and December 31, 2022 and 4,313,406 issued and outstanding as of December 31, 2023 and December 31, 2022
4
4
Additional paid-in capital
137,021
132,939
Accumulated deficit
( 175,644 )
( 137,988 )
Total stockholders’ equity (deficit)
( 38,600 )
( 5,033 )
Total liabilities and stockholders' equity (deficit)
$
43,428
$
68,841
The accompanying notes are an integral part of these consolidated financial statements.
F-3
Table of Contents
ELUTIA INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In Thousands, Except Share and Per Share Data)
Year Ended
December 31,
2023
2022
Net sales
$
24,745
$
23,849
Cost of goods sold
13,692
12,210
Gross profit
11,053
11,639
Sales and marketing
13,087
17,850
General and administrative
14,104
16,051
Research and development
4,399
7,727
FiberCel litigation costs, net
9,989
5,200
Total operating expenses
41,579
46,828
Loss from continuing operations
( 30,526 )
( 35,189 )
Interest expense
5,796
5,118
Other expense (income), net
4,899
( 4,159 )
Loss before provision for income taxes
( 41,221 )
( 36,148 )
Income tax expense
28
34
Net loss from continuing operations
( 41,249 )
( 36,182 )
Income from discontinued operations
3,593
3,285
Net loss
$
( 37,656 )
$
( 32,897 )
Net loss per share from continuing operations attributable to common stockholders - basic and diluted
$
( 2.27 )
$
( 2.62 )
Net income per share from discontinued operations attributable to common stockholders - basic and diluted
$
0.20
$
0.24
Net loss per share - basic and diluted
$
( 2.07 )
$
( 2.38 )
Weighted average common shares outstanding - basic and diluted
18,160,822
13,832,887
The accompanying notes are an integral part of these consolidated financial statements.
F-4
Table of Contents
ELUTIA INC.
CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
(In Thousands, Except Share and Per Share Data)
Class A
Class B
Common Stock
Common Stock
Additional
Total
Number of
Number of
Paid-in
Accumulated
Stockholders'
Shares
Amount
Shares
Amount
Capital
Deficit
Equity (Deficit)
Balance, December 31, 2021
9,245,146
$
9
4,313,406
$
4
$
118,599
$
( 105,091 )
$
13,521
Proceeds from stock option exercises
13,887
—
—
—
78
—
78
Additional issuance costs in connection with private placement
—
—
—
—
—
—
—
Proceeds from sale of common stock through Employee Stock Purchase Plan
74,408
—
—
—
317
—
317
Proceeds from sale of common stock in secondary public offering, net of issuance costs of $ 1,074
2,350,000
3
—
—
10,086
—
10,089
Vesting of restricted stock units, net of shares withheld and taxes paid
140,004
—
—
—
( 395 )
—
( 395 )
Issuance of warrants in connection with debt financing
—
—
—
—
607
—
607
Stock-based compensation
—
—
—
—
3,647
—
3,647
Net loss
—
—
—
—
—
( 32,897 )
( 32,897 )
Balance, December 31, 2022
11,823,445
$
12
4,313,406
$
4
$
132,939
$
( 137,988 )
$
( 5,033 )
Proceeds from sale of common stock in connection with private placement, net of issuance costs of $ 0.4 million
6,852,811
7
—
—
1,458
—
1,465
Proceeds from sale of common stock through Employee Stock Purchase Plan
104,905
—
—
—
219
—
219
Vesting of restricted stock units, net of shares withheld and taxes paid
103,035
—
—
—
( 32 )
—
( 32 )
Stock-based compensation
—
—
—
—
2,437
—
2,437
Net loss
—
—
—
—
—
( 37,656 )
( 37,656 )
Balance, December 31, 2023
18,884,196
$
19
4,313,406
$
4
$
137,021
$
( 175,644 )
$
( 38,600 )
The accompanying notes are an integral part of these consolidated financial statements.
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ELUTIA INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In Thousands)
Year Ended
December 31,
2023
2022
Net loss
$
( 37,656 )
$
( 32,897 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
3,748
3,733
Gain on sale of Orthobiologics Business, excluding divestiture costs
( 7,529 )
—
Loss on extinguishment of debt and revaluation of warrant liability
4,140
311
Gain on revaluation of revenue interest obligation
—
( 4,962 )
Amortization of deferred financing costs and debt discount
216
115
Interest expense recorded as additional revenue interest obligation or long-term debt
3,350
2,908
Stock-based compensation
2,437
3,647
Bad debt expense
590
—
Losses associated with viable bone matrix recall and market withdrawal
1,984
—
Changes in operating assets and liabilities, net:
Accounts receivable
802
( 834 )
Inventory
( 609 )
( 498 )
Receivables of FiberCel litigation costs
11,118
( 13,813 )
Prepaid expenses and other
167
( 1,526 )
Accounts payable and accrued expenses and payables to tissue suppliers
( 2,113 )
5,593
Contingent liability for FiberCel litigation
( 2,336 )
17,360
Other liabilities
( 70 )
( 571 )
Net cash used in operating activities
( 21,761 )
( 21,434 )
INVESTING ACTIVITIES:
Proceeds from sale of Orthobiologics Business
14,554
—
Expenditures for property, plant and equipment
( 346 )
( 540 )
Net cash provided by (used in) investing activities
14,208
( 540 )
FINANCING ACTIVITIES:
Proceeds from public offering or private placement with warrants, net of offering costs
10,085
10,089
Repayments under revolving line of credit
—
( 4,763 )
Proceeds from stock option exercises
—
78
Proceeds (repayments) of long-term debt, net
( 1,955 )
6,385
Deferred financing costs
—
( 468 )
Costs related to the extinguishment of debt
—
( 633 )
Payments on revenue interest obligation
—
( 2,075 )
Proceeds from insurance premium financings
1,995
Repayments of insurance premium financings
( 472 )
Payments for taxes upon vesting of restricted stock units
( 32 )
( 395 )
Proceeds from sales of common stock through Employee Stock Purchase Plan
219
317
Net cash provided by financing activities
9,840
8,535
Net increase (decrease) in cash
2,287
( 13,439 )
Cash and cash equivalents, beginning of period
16,989
30,428
Cash and cash equivalents, end of period
$
19,276
$
16,989
Supplemental Cash Flow and Non-Cash Financing Activities Disclosures:
Cash paid for interest
$
2,321
$
5,480
Fair value of warrants issued
$
12,760
$
607
The accompanying notes are an integral part of these consolidated financial statements.
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ELUTIA INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 1. Organization and Description of Business
Elutia Inc. (together with its consolidated subsidiaries, "Elutia” or the “Company”) is a commercial-stage company leveraging its unique understanding of biologics to improve the interaction between implanted medical devices and patients by reducing complications associated with these surgeries. The Company has developed a portfolio of products using both human and porcine tissue that are designed to be as close to natural biological material as possible. Elutia’s portfolio of products spans the Device Protection, Women’s Health and Cardiovascular markets. These products are primarily sold to healthcare providers or commercial partners.
Note 2. Summary of Significant Accounting Policies
Basis of Presentation and Liquidity
The consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”).
The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. Intercompany accounts and transactions have been eliminated in consolidation.
On November 8, 2023, the Company completed the sale of substantially all of the assets relating to its Orthobiologics segment (the “Orthobiologics Business”) to Berkeley Biologics, LLC (“Berkeley”). The Orthobiologics Business was comprised of assets relating to researching, developing, administering, insuring, operating, commercializing, manufacturing, selling and marketing the Company’s Orthobiologics products, and the business of contract manufacturing of particulate bone, precision milled bone, cellular bone matrix, acellular dermis, soft tissue and other products. The assets sold represent the entirety of the Company’s Orthobiologics segment. In the sale, the Company received approximately $ 14.6 million, and the Company may earn up to an additional $ 20 million, in the aggregate, in the form of earn-out payments. The earn-out payments are equal to 10 % of the actual revenue earned by Berkeley in each of the five years after the closing of the sale from sales of specified Orthobiologics products under the purchase agreement (including improvements, modifications, derivatives and enhancements related to those products). Additionally, the purchase agreement provides for a customary indemnity holdback in the amount of $ 1.5 million to be retained by Berkeley for 24 months after close. The Company recognized a gain of approximately $ 6.0 million on the sale of the Orthobiologics Business which is recorded in " Income from discontinued operations " in the Company's consolidated statement of operations for the year ended December 31, 2023. Should the Company receive incremental proceeds in the future through an Earn-Out Payment or payment of the holdback amount, an additional gain will be recorded upon the receipt of such amounts.
The sale of the Orthobiologics Business represents a strategic shift that has a major effect on the Company’s operations and financial results. Accordingly, this transaction is accounted for as Discontinued Operations for all periods presented in accordance with Accounting Standards Codification (“ASC”) 205-20, Discontinued Operations . Unless indicated otherwise, the information in the notes to the consolidated financial statements relates to continuing operations. See Note 4 for further discussion of the divestiture of the Orthobiologics Business.
In accordance with Accounting Standards Update (“ASU”) 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40) , the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the consolidated financial statements are issued. For the year ended December 31, 2023, the Company incurred a net loss of $ 37.7 million, and as of December 31, 2023, the Company had an accumulated deficit of $ 175.6 million. In addition, during the year ended December 31, 2023, the Company used $ 21.8 million of cash in operating activities and expects to continue to incur cash outflows in 2024. Because of the numerous risks and uncertainties associated with the Company’s commercialization and development efforts, the Company is unable
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to predict when it will become profitable, and it may never become profitable. The Company’s inability to achieve and then maintain profitability would negatively affect its business, financial condition, results of operations and cash flows. Furthermore, even if the Company does achieve profitability, it may not be able to sustain or increase profitability on an ongoing basis, or, in general, be able to satisfy its obligations, including those related to the FiberCel Recall described in Note 17, when they become due.
In order to mitigate the current and potential future liquidity issues caused by the matters noted above, the Company may seek to raise capital through the issuance of common stock, such as the private placement which we closed in September 2023, which is described further in Note 14, or pursue asset sale or other transactions, such as the sale of the Orthobiologics Business described above. However, such transactions may not be successful and the Company may not be able to raise additional equity or sell or license assets on acceptable terms, or at all. As such, based on its current operating plans, the Company believes there is uncertainty as to whether its future cash flows along with its existing cash, issuances of additional equity and cash generated from expected future sales will be sufficient to meet the Company’s anticipated operating needs through twelve months from the financial statement issuance date. Due to these factors, there is substantial doubt about the Company’s ability to continue as a going concern within one year after the issuance of the financial statements.
The accompanying consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. That is, the accompanying financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates continuity of operations, realization of assets, and satisfaction of liabilities in the ordinary course of business.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Estimates and assumptions relating to inventories, receivables, long-lived assets, the valuation of stock-based awards, the valuation of the revenue interest obligation, the valuation of the warrant liability, the contingent liability for the FiberCel Litigation and deferred income taxes are made at the end of each financial reporting period by management. Management continually re-evaluates its estimates, judgments and assumptions, and management's evaluation could change. Actual results could differ from those estimates.
Net Loss per Share Attributable to Common Stockholders
Our common stock has a dual class structure, consisting of Class A common stock, $ 0.001 par value per share (the “Class A common stock) and Class B common stock, $ 0.001 par value per share (the “Class B common stock). Other than voting rights, the Class B common stock has the same rights as the Class A common stock, and therefore both are treated as the same class of stock for purposes of the earnings per share calculation. Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average shares outstanding during the period. For purposes of the diluted net income (loss) per share attributable to common stockholders calculation, stock options, restricted stock units (“RSUs”) and certain warrants are considered to be common stock equivalents. All common stock equivalents have been excluded from the calculation of diluted net loss per share attributable to common stockholders, as their effect would be anti-dilutive for all periods presented. Therefore, basic and diluted net loss per share were the same for both periods presented.
Fair Value of Financial Instruments
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. To increase the comparability of fair value measures, the following hierarchy prioritizes the inputs to valuation methodologies used to measure fair value:
Level 1 - Valuations based on quoted prices for identical assets and liabilities in active markets.
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Level 2 - Valuations based on observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data.
Level 3 - Valuations based on unobservable inputs reflecting the Company’s own assumptions, consistent with reasonably available assumptions made by other market participants. These valuations require significant judgment.
The estimated fair value of financial instruments disclosed in the financial statements has been determined by using available market information and appropriate valuation methodologies. The carrying value of all current assets and current liabilities approximates fair value because of their short-term nature.
Cash and Cash Equivalents
The Company maintains its cash balances at banks and financial institutions. The balances are insured up to the legal limit. The Company maintains cash balances that may, at times, exceed this insured limit. The Company considers cash on hand, demand deposits in a bank, money market funds, and all highly liquid investments with an original maturity of 90 days or less to be cash and cash equivalents.
Accounts Receivable and Allowances
Accounts receivable in the accompanying balance sheets are presented net of allowances for doubtful accounts and other credits. The Company grants credit to customers in the normal course of business, but generally does not require collateral or any other security to support its receivables.
The Company evaluates the collectability of accounts receivable based on a combination of factors. In circumstances where a specific customer is unable to meet its financial obligations to the Company, a provision to the allowance for doubtful accounts is recorded to reduce the net recognized receivable to the amount that is reasonably expected to be collected. For all other customers, a provision to the allowance for doubtful accounts is recorded based on factors including the length of time the receivables are past due, the current business environment and the Company’s historical experience. Provisions to the allowance for doubtful accounts are recorded to general and administrative expenses. Account balances are charged off against the allowance when it is probable that the receivable will not be recovered. The Company's allowance for doubtful accounts was approximately $ 0.7 million and $ 0.1 million as of December 31, 2023 and 2022, respectively.
Inventories
Inventories, consisting of purchased materials, direct labor and manufacturing overhead, are stated at the lower of cost or net realizable value, with cost determined generally using the average cost method. At each balance sheet date, the Company also evaluates inventories for excess quantities, obsolescence or shelf life expiration. This evaluation includes analysis of the Company’s current and future strategic plans, historical sales levels by product, projections of future demand, the risk of technological or competitive obsolescence for products, general market conditions and a review of the shelf life expiration dates for products. To the extent that management determines there is excess or obsolete inventory or quantities with a shelf life that is too near its expiration for the Company to reasonably expect that it can sell those products prior to their expiration, the Company adjusts the carrying value to estimated net realizable value.
Property and Equipment
Property and equipment are stated at cost less accumulated depreciation. Depreciation is computed on the straight-line method over the following estimated useful lives of the assets:
Processing and research equipment
5 to 10 years
Office equipment and furniture
3 to 5 years
Computer hardware and software
3 years
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Leasehold improvements are amortized on the straight-line method over the shorter of the lease term or the estimated useful life of the asset. Repairs and maintenance costs are expensed as incurred.
Leases
In February 2016, the FASB issued ASU No 2016-02 “Leases” to increase the transparency and comparability about leases among entities. Additional ASUs have been issued subsequent to ASU 2016-02 to provide supplementary clarification and implementation guidance for leases related to, among other things, the application of certain practical expedients, the rate implicit in the lease, lessee reassessment of lease classification, lessor reassessment of lease term and purchase options, variable payments that depend on an index or rate and certain transition adjustments. ASU 2016-02 and these additional ASUs are now codified as Accounting Standards Codification Standard 842 - “Leases” (“ASC 842”). ASC 842 supersedes the lease accounting guidance in Accounting Standards Codification 840 “Leases” (“ASC 840”) and requires lessees to recognize a lease liability and a corresponding lease asset for virtually all lease contracts. It also requires additional disclosures about leasing arrangements. The Company elected to utilize the “package” of expedients, as defined in ASC 842, which retain the lease classification and initial direct costs for any leases that existed prior to adoption of the standard. Accordingly, previously reported financial information has not been restated to reflect the application of the new standard to the comparative periods presented. The Company adopted the standard in the fourth quarter of 2022 for the full 2022 year resulting in the recognition of a Right-of-use (“ROU”) asset and operating lease liability on the Company’s consolidated balance sheet of approximately $ 2.4 million as of January 1, 2022 . As the ROU asset and the lease payable obligation were essentially the same upon adoption of ASC 842 , there was no cumulative effect impact on the Company’s accumulated deficit.
The Company determines if an arrangement contains a lease at inception. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from that lease. For leases with a term greater than 12 months, ROU assets and liabilities are recognized at the lease commencement date based on the estimated present value of lease payments over the lease term. The lease term includes the option to extend the lease when it is reasonably certain the Company will exercise that option. When available, the Company uses the rate implicit in the lease to discount lease payments to present value. In the case the implicit rate is not available, the Company uses its incremental borrowing rate based on information available at the lease commencement date, including publicly available data for instruments with similar characteristics, to determine the present value of lease payments. The Company combines lease and non-lease elements for office leases.
Long-Lived Assets
Purchased intangible assets with finite lives are carried at acquired fair value, less accumulated amortization. Amortization is computed over the estimated useful lives of the respective assets.
The Company periodically evaluates the period of depreciation or amortization for long-lived assets to determine whether current circumstances warrant revised estimates of useful lives. The Company reviews its property and equipment and intangible assets for impairment whenever events or changes in circumstances indicate the carrying value of an asset may not be recoverable. Impairment exists when the carrying value of the company’s asset exceeds the related estimated undiscounted future cash flows expected to be derived from the asset. If impairment exists, the carrying value of that asset is adjusted to its fair value. A discounted cash flow analysis is used to estimate an asset’s fair value, using assumptions that market participants would apply. The results of impairment tests are subject to management’s estimates and assumptions of projected cash flows and operating results. Changes in assumptions or market conditions could result in a change in estimated future cash flows and could result in a lower fair value and therefore an impairment, which could impact reported results. There were no impairment losses for the years ended December 31, 2023 and 2022.
Warrant Liability
The Company accounts for its warrants in accordance with ASC 815, Derivatives and Hedging – Contracts in Entity's Own Equity , as either liabilities or as equity instruments depending on the specific terms of the warrant agreement. The Prefunded and Common Warrants issued in connection with the September 2023 private placement (see Note 14) are
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classified as liabilities and are recorded at fair value. The warrants are subject to re-measurement at each settlement date and at each balance sheet date and any change in fair value is recognized in other expense (income), net in the consolidated statements of operations. The Company estimates the fair value of the warrant liability using a Black-Scholes pricing model. We are required to make assumptions and estimates in determining an appropriate term, risk-free interest rate, volatility factor, dividend yield, and the fair value of common stock. Any significant adjustments to the unobservable inputs would have a direct impact on the fair value of the warrant liability.
Revenue Recognition
The Company’s revenue is generated from contracts with customers in accordance with ASC 606. The core principle of ASC 606 is that the Company recognizes revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. The ASC 606 revenue recognition model consists of the following five steps: (1) identify the contracts with a customer, (2) identify the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract and (5) recognize revenue when (or as) the entity satisfies a performance obligation.
As noted above, the Company enters into contracts to primarily sell and distribute products to healthcare providers or commercial partners. Revenue is recognized when the Company has met its performance obligations pursuant to its contracts with its customers in an amount that the Company expects to be entitled to in exchange for the transfer of control of the products to the Company’s customers. For all product sales, the Company has no further performance obligations and revenue is recognized at the point control transfers which occurs either when: i) the product is shipped via common carrier; or ii) the product is delivered to the customer or distributor, in accordance with the terms of the agreement.
A portion of the Company’s product revenue is generated from consigned inventory maintained at hospitals and from inventory physically held by distributors and direct sales representatives. For these types of products sales, the Company retains control until the product has been shipped, used or implanted, at which time revenue is recognized.
The Company elected to account for shipping and handling activities as a fulfillment cost rather than a separate performance obligation. Amounts billed to customers for shipping and handling are included as part of the transaction price and recognized as revenue when control of the underlying products is transferred to the customer. The related shipping and freight charges incurred by the Company are included in sales and marketing costs. Shipping and handling costs were not material in both the years ended December 31, 2023 and 2022, respectively.
Contracts with customers state the final terms of the sale, including the description, quantity, and price of each implant distributed. The payment terms and conditions in the Company’s contracts vary; however, as a common business practice, payment terms are typically due in full within 30 to 60 days of delivery. The Company, at times, extends volume discounts to customers.
The Company permits returns of its products in accordance with the terms of contractual agreements with customers. Allowances for returns are provided based upon analysis of the Company’s historical patterns of returns matched against the revenues from which they originated. The Company records estimated returns as a reduction of revenue in the same period revenue is recognized.
Stock-Based Compensation Plans
The Company accounts for its stock-based compensation plans in accordance with FASB Accounting Standards Codification (“ASC”) 718, Accounting for Stock Compensation . FASB ASC 718 requires the measurement and recognition of compensation expense for all stock-based awards made to employees and directors, including employee stock options and restricted stock units. Stock-based compensation cost is measured at the grant date, based on the calculated fair value of the award, and is recognized as an expense on a straight-line basis over the requisite service period of the entire award.
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Research and Development Costs
Research and development costs, which include mainly salaries, outside services and supplies, are expensed as incurred.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash. The Company’s cash balances with the individual institutions may at times exceed the federally insured limits.
As of December 31, 2023, there was one customer that represented 10 % of the Company’s net sales for the year ended 2023 and another customer that represented 31 % of the Company’s accounts receivable as of December 31, 2023.
Comprehensive Income (Loss)
Comprehensive income (loss) comprises net income (loss) and other changes in equity that are excluded from net income (loss). For the years ended December 31, 2023 and 2022, the Company’s net loss equaled its comprehensive loss and accordingly, no additional disclosure is presented.
Income Taxes
The Company uses the asset and liability method of accounting for income taxes. Deferred income taxes are recorded to reflect the tax consequences on future years for differences between the tax basis of assets and liabilities and their financial reporting amounts at each year-end based on enacted tax laws and statutory tax rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to amounts that are more likely than not to be realized.
The Company is subject to income taxes in the federal and state jurisdictions. Tax regulations within each jurisdiction are subject to the interpretation of the related tax laws and regulations and require significant judgment to apply. In accordance with the authoritative guidance on accounting for uncertainty in income taxes, the Company recognizes tax liabilities for uncertain tax positions when it is more likely than not that a tax position will not be sustained upon examination and settlement with various taxing authorities. Liabilities for uncertain tax positions are measured based upon the largest amount of benefit that is more likely than not (greater than 50%) of being realized upon settlement. The Company’s policy is to recognize interest and/or penalties related to income tax matters in income tax expense.
Note 3. Recently Issued Accounting Standards
In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. This update improves reportable segment disclosure requirements, primarily through enhanced disclosures of significant segment expenses. The amendments in this update should be applied retrospectively to all prior periods presented in the consolidated financial statements and are effective for fiscal years beginning after December 31, 2023 and interim periods within fiscal years beginning after December 31, 2024. Early adoption is permitted. The Company is currently evaluating the potential impact of this guidance on its consolidated financial statements.
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvement to Income Tax Disclosures. This update improves income tax disclosure requirements, primarily through enhanced transparency and decision usefulness of disclosures. The amendments in this update should be applied prospectively with the option to apply retrospectively and are effective for fiscal years beginning after December 15, 2024. Early adoption is permitted. The Company is currently evaluating the potential impact of this guidance on its consolidated financial statements.
Note 4. Sale of Orthobiologics Business
As described in Note 2, on November 8, 2023, the Company completed the sale of its Orthobiologics Business. The sale of the Orthobiologics Business represents a strategic shift that has a major effect on the Company’s operations and financial results. Accordingly, the Orthobiologics Business is reported as discontinued operations in accordance with
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ASC 205-20 - Discontinued Operations . The related assets and liabilities of the Orthobiologics Business are classified as assets and liabilities of discontinued operations as of December 31, 2022 in the consolidated balance sheets and the results of operations from the Orthobiologics Business are reported as discontinued operations in the consolidated statements of operations for the years ended December 31, 2023 and 2022, with the year ended December 31, 2023 including the financial results from January 1, 2023 through the transaction closing date of November 8, 2023. Applicable amounts in the prior year have been recast to conform to this discontinued operations presentation.
The following tables show the assets and liabilities of the discontinued operations:
Year Ended December 31, 2022
Carrying amounts of the major classes of assets included in discontinued operations:
Accounts receivable, net
$
3,056
Inventory
5,812
Prepaid expenses and other current assets
628
Total current assets
9,496
Property and equipment, net
1,158
Operating lease right-of-use assets and other
1,350
Total non-current assets
2,508
Total assets of discontinued operations
$
12,004
Carrying amounts of the major classes of liabilities included in discontinued operations:
Accounts payable
$
954
Accrued expenses and other current liabilities
1,273
Payables to tissue suppliers
2,252
Current operating lease liabilities
450
Total current liabilities
4,929
Long-term operating lease liabilities
956
Total liabilities of discontinued operations
$
5,885
In accordance with ASC 205-20, only expenses specifically identifiable and related to a business to be disposed may be presented in discontinued operations. The following table shows the financial results of the discontinued operations for the years ended December 31, 2023 and 2022, with the year ended December 31, 2023 including the financial results from January 1, 2023 through the transaction closing date of November 8, 2023:
Year Ended
December 31,
2023
2022
Net sales
$
14,913
$
25,338
Cost of goods sold
12,682
17,755
Gross profit
2,231
7,583
Sales and marketing
1,784
2,345
General and administrative
1,534
576
Research and development
951
1,213
Total operating expenses
4,269
4,134
Interest Expense
348
164
Net income (loss)
$
( 2,386 )
3,285
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Total operating and investing cash flows of discontinued operations for the years ended December 31, 2023 and 2022 are comprised of the following:
Year Ended
December 31,
2023
2022
Significant operating non-cash reconciliation items:
Depreciation
$
239
$
167
Stock-based compensation
86
144
Changes in operating assets and liabilities:
Accounts receivable
882
( 417 )
Inventory
988
956
Prepaid expenses and other
( 449 )
39
Accounts payable and accrued expenses and other current liabilities
( 1,562 )
( 127 )
Obligations to tissue suppliers
( 691 )
130
Significant investing items:
Expenditures for property, plant and equipment
( 225 )
( 378 )
The Company’s Women’s Health product, SimpliDerm, has historically been processed by Elutia at the Company’s Richmond, California facility; however, with the divestiture of the Orthobiologics Business, which includes such facility, SimpliDerm will be provided to the Company on a go forward basis through a long-term supply agreement with the purchaser, Berkeley.
Note 5. Stock-Based Compensation
In 2015, the Company established the Elutia Inc. 2015 Stock Option/Stock Issuance Plan, as amended (the “2015 Plan”) which provided for the granting of incentive and non-qualified stock options to employees, directors and consultants of the Company. On October 7, 2020, in connection with the Company’s IPO, the Company adopted the Elutia Inc. 2020 Incentive Award Plan, and on June 8, 2023, the Company’s stockholders approved the amendment and restatement of that plan (as amended and restated, the “2020 Plan”), which authorizes the grant of incentive and non-qualified stock options, restricted stock, restricted stock units and stock appreciation rights to employees, directors and consultants. Shares of Class A common stock totaling 1,636,000 were initially reserved for issuance pursuant to the 2020 Plan, and in June 2023, the number of shares of Class A common stock reserved for issuance under the 2020 Plan was increased by 2,000,000 shares. In addition, the shares reserved for issuance under the 2020 Plan also include shares reserved but not issued under the 2015 Plan as well as an annual increase as set forth in the 2020 Plan. As of December 31, 2023, the Company had 3,401,678 shares of Class A common stock available for issuance under the 2020 Plan, and on January 1, 2024, the shares available for issuance were increased by 927,904 pursuant to the automatic increase provisions of the plan. On January 31, 2024, we granted stock options covering 1,615,561 shares of Class A common stock and restricted stock units covering 2,267,500 shares of Class A common stock to employees and consultants under the 2020 Plan.
Stock Options
The Company’s policy is to grant stock options at an exercise price equal to 100 % of the market value of a share of Class A common stock at closing on the date of the grant. The Company’s stock options have contractual terms of ten years , and generally vest over a four-year period from the date of grant.
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A summary of stock option activity under the Company’s 2015 Plan and 2020 Plan for the years ended December 31, 2023 is as follows:
Weighted-
Average
Weighted-
Remaining
Aggregate
Average
Contractual
Intrinsic
Exercise
Term
Value
Number of Shares
Price
(years)
(in thousands)
Outstanding, December 31, 2022
1,864,739
$
9.41
7.5
$
8
Granted
157,500
$
2.64
Exercised
—
$
—
Forfeited
( 521,046 )
$
10.36
Outstanding, December 31, 2023
1,501,193
$
8.37
7.8
$
-
Vested and exercisable, December 31, 2023
786,058
$
10.00
7.1
$
-
As of December 31, 2023, there was approximately $ 1.9 million of total unrecognized compensation expense related to unvested stock options. These costs are expected to be recognized over a weighted- average period of 1.9 years. The weighted average grant date fair value of options granted during the years ended December 31, 2023 and 2022 were $ 1.63 and $ 3.30 , respectively. The total intrinsic value of options exercised was not material for both the years ended December 31, 2023 and 2022.
The Company uses the Black-Scholes model to value its stock option grants that vest based on the passage of time or the achievement of certain performance criteria and expenses the related compensation cost using the straight-line method over the vesting period. The fair value of stock options is determined on the grant date using assumptions for the estimated fair value of the underlying common stock, expected term, expected volatility, dividend yield, and the risk-free interest rate. Before the completion of the Company’s IPO, the Board of Directors determined the fair value of common stock considering the state of the business, input from management, third party valuations and other considerations. The Company uses the simplified method for estimating the expected term used to determine the fair value of options. The expected volatility of the Class A common stock is partially based on the historical volatility of comparable companies in the industry whose share prices are publicly available. The Company uses a zero -dividend yield assumption as the Company has not paid dividends since inception nor does it anticipate paying dividends in the future. The risk-free interest rate approximates recent U.S. Treasury note auction results with a similar life to that of the option. The period expense is then determined based on the valuation of the options and is recognized on a straight-line basis over the requisite service period for the entire award.
The following weighted-average assumptions were used to determine the fair value of options during the years ended December 31, 2023 and 2022:
Year Ended
December 31,
2023
2022
Expected term (years)
6.0
6.2
Risk-free interest rate
3.9
%
2.3
%
Volatility factor
63.8
%
63.8
%
Dividend yield
—
—
The Company has also granted to President and Chief Executive Officer stock options that vest in equal installments upon the achievement of certain share price thresholds for twenty consecutive days of trading at each respective threshold. For these stock options, the Company accounted for the awards as market condition awards and used an option pricing model, the Monte Carlo model, to determine the fair value of the respective equity instruments and an expense recognition term of approximately three years . As of December 31, 2023, there are 182,511 stock options outstanding that are market condition stock option awards.
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Restricted Stock Units
Restricted stock units (“RSUs”) represent rights to receive common shares at a future date. There is no exercise price and no monetary payment is required for receipt of restricted stock units or the shares issued in settlement of the award.
A summary of the RSU activity under the Company’s 2020 Plan for the year ended December 31, 2023 is as follows:
Weighted-
Average
Number of Shares
Grant Date
Underlying RSUs
Fair Value
Unvested, December 31, 2022
372,307
$
5.90
Granted
122,000
$
2.12
Vested
( 75,996 )
$
11.69
Forfeited
( 82,703 )
$
3.93
Unvested, December 31, 2023
335,608
$
3.64
The total fair value of the RSUs granted during the year ended December 31, 2023 and 2022 of $ 0.3 million and $ 2.4 million, respectively was based on the fair market value of the Company's Class A common stock on the date of grant. The fair value at the time of the grant is amortized to expense on a straight-line basis over the vesting period of three to four years .
The Company has also granted to President and Chief Executive Officer RSUs that vest in equal installments upon the achievement of certain share price thresholds for twenty consecutive days of trading at each respective threshold. For these RSUs, the Company accounted for the awards as market condition awards and used a Monte Carlo model to determine the fair value of these RSUs as well as the expense recognition term of two to three years using the graded vesting method. As of December 31, 2023, there were 89,894 RSUs outstanding that were market condition RSU awards.
As of December 31, 2023, $ 0.8 million of unrecognized compensation costs related to RSUs is expected to be recognized over a weighted average period of approximately two years .
Employee Stock Purchase Plan
The Company makes shares of its Class A common stock available for purchase under the Elutia Inc. 2020 Employee Stock Purchase Plan (the “ESPP”). The ESPP provides for separate six-month offering periods that begin in March and September of each year. Under the ESPP, employees may purchase a limited number of shares of Elutia Class A common stock at 85 % of the fair market value on either the first day of the offering period or the purchase date, whichever is lower. The ESPP is considered compensatory for purposes of stock-based compensation expense. The number of shares reserved under the ESPP will automatically increase on the first day of each fiscal year through January 1, 2030, in an amount equal to the lesser of (i) 1 % of the total shares of Class A common stock outstanding on the final day of the immediately preceding calendar year; or (ii) a lesser number of shares determined by the Company’s board of directors. As of December 31, 2023, the total shares of Class A common stock authorized for issuance under the ESPP was 542,365 of which 335,808 remained available for future issuance. During the year ended December 31, 2023, 104,905 shares of Class A common stock were issued under the ESPP.
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Stock-Based Compensation Expense
Stock-based compensation expense recognized during the years ended December 31, 2023 and 2022 comprised of the following (in thousands):
Year Ended
December 31,
2023
2022
Sales and marketing
$
569
$
1,041
General and administrative
1,607
1,922
Research and development
122
466
Cost of goods sold
107
74
Total stock-based compensation expense
$
2,405
$
3,503
Note 6. Inventory
Inventory as of December 31, 2023 and 2022 was comprised of the following (in thousands):
December 31,
2023
2022
Raw materials
$
242
$
652
Work in process
286
541
Finished goods
3,325
3,047
Total
$
3,853
$
4,240
Note 7. Property and Equipment
Property and equipment as of December 31, 2023 and 2022 were comprised of the following (in thousands):
December 31,
2023
2022
Processing and research equipment
$
381
$
( 1,000 )
Leasehold improvements
92
613
Office equipment and furniture
86
188
Computer hardware and software
194
1,029
753
830
Less: accumulated depreciation and amortization
( 581 )
( 585 )
Property and equipment, net
$
172
$
245
Depreciation and amortization expense on property and equipment totaled approximately $ 0.1 million in both the years ended December 31, 2023 and 2022. Amounts included within cost of goods sold are not material.
Note 8. Leases
The Company leases one production facility, one administrative and research facility and one administrative facility under non-cancelable operating lease arrangements that expire through July 2024. Our administrative and research facility contains renewal options and escalation clauses based upon increases in the lessors’ operating expenses and other charges.
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The following is a summary of the Company’s ROU assets and operating lease liabilities as of December 31, 2023 and 2022 (in thousands):
December 31,
Classification on the Balance Sheet
2023
2022
Assets
Operating leases assets
Operating lease right-of-use assets and other
$
271
$
226
Liabilities
Operating leases current liabilities
Current operating lease liabilities and other
275
232
Operating leases non-current liabilities
Long-term operating lease liabilities
-
—
Total lease liabilities
$
275
$
232
Weighted average remaining lease term
0.6
Weighted average discount rate
7.2 %
For the years ended December 31, 2023 and 2022, the Company recognized operating lease cost of approximately $ 0.5 million and $ 0.4 million, respectively. Cash paid for amounts included in the measurement of operating lease liabilities are included in operating cash flows and were approximately $ 0.6 million and $ 0.4 million for the years ended December 31, 2023 and 2022, respectively.
The table below reconciles the Company’s future cash obligations to the operating lease liabilities recorded on the balance sheet as of December 31, 2023 (in thousands):
Years ending December 31,
2024
$
281
2025
—
2026
—
Total minimum lease payments
281
Less: amount of lease payments representing interest
( 6 )
Present value of future minimum lease payments
275
Less: current operating lease liabilities
( 275 )
Long-term operating lease liabilities
$
—
Note 9. Intangible Assets
On May 31, 2017, the Company completed an asset purchase agreement with CorMatrix Cardiovascular, Inc. (“CorMatrix”) and acquired all CorMatrix commercial assets and related intellectual property. A substantial portion of the assets acquired consisted of intangible assets related to the acquired products and customer relationships. Management determined that the estimated acquisition-date fair values of the intangible assets related to acquired products and customer relationships were $ 29.3 million and $ 4.7 million, respectively.
The components of identified intangible assets as of December 31, 2023 and 2022 are as follows (in thousands):
December 31, 2023
December 31, 2022
Accumulated
Accumulated
Cost
Amortization
Net
Cost
Amortization
Net
Acquired products
$
29,317
$
( 19,260 )
$
10,057
$
29,317
$
( 16,334 )
$
12,983
Customer relationships
4,723
( 3,109 )
1,614
4,723
( 2,637 )
2,086
Total
$
34,040
$
( 22,369 )
$
11,671
$
34,040
$
( 18,971 )
$
15,069
Acquired products and customer relationships are both amortized over a ten-year period. Amortization expense totaled approximately $ 3.4 million for each of the years ended December 31, 2023 and 2022, which is included in cost of
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goods sold in the accompanying consolidated statements of operations. Annual amortization expense is expected to be approximately $ 3.4 million during the years ended December 31, 2024 through 2026 and approximately $ 1.5 million during the year ended December 31, 2027.
Note 10. Long-Term Debt
On May 31, 2017, the Company entered into a $ 12 million term loan facility (“MidCap Loan Facility”) and an $ 8.0 million asset-backed revolving line of credit (“MidCap Credit Facility”), under which the Company’s borrowing capacity was limited by certain qualifying assets, with MidCap Financial Trust (“May 2017 Financing”). The MidCap Loan Facility was amended in December 2017, February 2018 and July 2019 (all amendments being considered modifications) such that an additional $ 1.5 million, $ 3.0 million, and $ 3.5 million, respectively were received by the Company bringing the total aggregate principal amount outstanding under the MidCap Loan Facility to $ 20 million. The borrowings under the MidCap Loan Facility and the MidCap Credit Facility were fully repaid with a portion of the proceeds from the SWK Loan Facility as more fully described below.
O n August 10, 2022, the Company entered into a senior secured term loan facility with SWK Funding LLC, as agent, and other lenders party thereto for an aggregate principal amount of $ 25 million, and the Company amended the facility on May 12, 2023 (as amended, the “SWK Loan Facility”). An initial draw of $ 21 million was made in August 2022, with the additional $ 4 million drawn on December 14, 2022 upon satisfaction of the amended terms enabling such receipt. The SWK Loan Facility also allows for the establishment of a separate, new asset-based revolving loan facility of up to $ 8 million, which has not been entered into to date. The SWK Loan Facility matures on August 10, 2027 and accrues interest, payable quarterly in arrears. Principal amortization of the SWK Loan Facility starts on November 15, 2024, which amortization may be extended to November 17, 2025 if certain conditions have been satisfied. Principal payments during the amortization period will be limited based on revenue-based caps. As of December 31, 2023, quarterly principal payments are scheduled to begin on November 15, 2024, in an amount equal to 5 % of the aggregate principal amount funded with the balance paid at maturity. T he SWK Loan Facility also includes both revenue and liquidity covenants, restrictions as to payment of dividends, and is secured by all assets of the Company, subject to certain customary exceptions. As of December 31, 2023, Elutia was in compliance with its financial covenants under the agreement governing the SWK Loan Facility (“SWK Loan Facility Agreement”).
All of the SWK Loan Facility borrowings take the form of Secured Overnight Financing Rate (“SOFR”) loans and bear interest at a rate per annum equal to the sum of an applicable margin of (i) 7.75 % and the “Term SOFR Rate” (based upon an interest period of 3 months), or (ii) if the Company has elected the PIK Interest option (as defined below), 3.75 % and the “Term SOFR Rate.” The Company may elect a portion of the interest due, to be paid in-kind at a rate per annum of 4.5 % (“PIK Interest”), and such election may be made (x) until November 15, 2024 if the conditions to draw the Additional Term Loan have not been met, or (y) if such conditions to draw the Additional Term Loan have been satisfied, until November 17, 2025. The “Term SOFR Rate” is subject to a floor of 2.75 %. The agreement governing the SWK Loan Facility also includes an exit fee equal to 6.5 % of the aggregate principal amount funded prior to termination plus $ 62,500 and prepayment penalties equal to: (i) if such prepayment occurs prior to the first anniversary of the Closing Date, 2 % of the aggregate principal amount funded prior to the termination plus remaining unpaid interest payments scheduled to be paid during the first year of the loan or (ii) if such prepayment occurs after the first anniversary of the Closing Date but prior to the second anniversary of the Closing Date, 2 % of the aggregate principal amount funded prior to the termination. The weighted average interest rate on the SWK Loan Facility was 13.2 % for the year ended December 31, 2023 and 12.6 % for the period from August 10, 2022 through December 31, 2022.
On August 10, 2022, the Company issued to SWK Funding LLC a warrant (“Class A Warrant”) to purchase, in the aggregate, up to 187,969 shares of Class A common stock of the Company, $ 0.001 par value per share at an exercise price of $ 6.65 per share. The Class A Warrant is immediately exercisable for up to 187,969 shares of Class A common stock from time to time on or after the Closing Date. The exercise price and number of shares of Class A common stock issuable upon exercise of the Class A Warrant are subject to adjustment in the event of stock dividends, stock splits and certain other events affecting the Class A common stock. Unless earlier exercised or terminated in accordance with its terms, the Class A Warrant will expire on the seventh anniversary of the Closing Date. Upon issuance, the Company valued the Class A Warrant at approximately $ 0.6 million using the Black-Scholes model. The recognition of the Class A Warrant as well as deferred financing costs of approximately $ 0.5 million incurred in securing the SWK Loan Facility
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served to reduce the recorded value of the associated debt. The debt discount and deferred financing costs will be recognized as interest expense through the maturity of the loan.
The Company used $ 16 million of the proceeds of the SWK Loan Facility to repay all outstanding obligations on the MidCap Loan Facility and MidCap Credit Facility. Such payment included (i) $ 12.8 million to repay all outstanding principal and accrued interest on the MidCap Loan Facility, (ii) $ 1.7 million to pay the prepayment and exit fees on the MidCap Loan Facility and (iii) $ 1.5 million to repay the outstanding balance, accrued interest and exit fees on the MidCap Credit Facility. The prepayment fees, payment of unaccrued exit fees and the write-off of unamortized deferred financing costs resulted in a loss to the Company of approximately $ 1.2 million which has been recorded as other expense (income), net in the accompanying consolidated statements of operations for the year ended December 31, 2022.
The SWK Loan Facility Agreement requires certain mandatory prepayments, subject to certain exceptions, with: (1) 100 % of any net casualty proceeds in excess of $ 250,000 and (2) for non-ordinary course asset sales, an amount equal to the difference between (x) the proportion of divested gross profit (as defined in the SWK Loan Facility Agreement) to the Company’s total gross profit (as defined in the SWK Loan Facility Agreement) multiplied by the outstanding loans under the SWK Loan Facility and (y) the difference between $ 1,000,000 and the aggregate sale proceeds of any assets previously sold during the fiscal year. No such mandatory prepayments were required during the year ended December 31, 2022; however, the closing of the divestiture of the Orthobiologics Business on November 8, 2023 triggered the mandatory prepayment of $ 4.0 million. Of such amount, $ 2.0 million wa s paid shortly after closing of the divestiture of the Orthobiologics Business and the remainder was paid on February 15, 2024 based on mutual agreement between the parties.
Borrowings under the MidCap Loan Facility, as amended, bore interest at a rate per annum equal to the sum of (x) the greater of (i) 2.25 % and (ii) the applicable London Interbank Offered Rate for U.S. dollar deposits divided by 1.00 minus the maximum effective reserve percentage for Eurocurrency funding (“LIBOR”) plus (y) 7.25 %. The weighted average interest rate on MidCap Loan Facility was 9.5 % from January 1, 2022 through August 10, 2022 (the “Repayment Date”). Borrowings under the MidCap Credit Facility bore interest at a rate per annum equal to the sum of (x) the greater of (i) 2.25 % and (ii) LIBOR plus (y) 4.95 %. The weighted average interest rate on MidCap Credit Facility was 7.2 % from January 1, 2022 through the Repayment Date.
During 2017, the Company restructured certain of its liabilities with a tissue supplier and entered into an unsecured promissory note totaling $ 2.1 million. The note bears interest at 5 % and includes quarterly interest-only payments in 2017 and quarterly interest and principal payments from March 31, 2018 through August 31, 2021. The Company used $ 1.4 million of the proceeds from the SWK Loan Facility to repay the remaining balance on the promissory note; however the accrued interest on the promissory note was forgiven by the lender. Such forgiveness resulted in a gain to the Company of approximately $ 0.4 million which has been recorded as other expense (income), net in the accompanying consolidated statements of operations for the year ended December 31, 2022.
As of December 31, 2023, the contractual maturities of the long-term debt are as follows (in thousands):
Years ending December 31,
Term Loan
2024
$
3,321
2025
5,282
2026
5,282
2027
10,571
Total
24,456
Debt Discount
( 440 )
Deferred Financing Costs
( 339 )
Total, net
23,677
Current Portion
( 3,321 )
Long-term Debt
$
20,356
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In addition to the above, the Company finances the annual premiums of certain insurance policies through short-term financing arrangements and includes the liabilities associated with such arrangements within accrued liabilities in accompanying consolidated balance sheets. The fair value of all debt instruments, which is based on inputs considered to be Level 2 under the fair value hierarchy, approximates the respective carrying values as of December 31, 2023 and 2022.
Note 11. Revenue Interest Obligation
As part of the CorMatrix asset acquisition described in Note 9, the Company assumed a restructured, long-term obligation (the “Initial Revenue Interest Obligation”) to Ligand Pharmaceuticals (“Ligand”) with an estimated present value on the acquisition date of $ 27.7 million. Subject to annual minimum payments of $ 2.75 million per year, the terms of the Initial Revenue Interest Obligation require Elutia to pay Ligand, 5 % of future sales of the products Elutia acquired from CorMatrix, including CanGaroo, ProxiCor, Tyke and VasCure, as well as products substantially similar to those products, such as the version of CanGaroo that Elutia is currently developing that is designed to include antibiotics. Furthermore, a $ 5.0 million payment will be due to Ligand if cumulative sales of these products exceed $ 100 million and a second $ 5.0 million will be due if cumulative sales exceed $ 300 million during the ten-year term of the agreement which expires on May 31, 2027.
On January 10, 2024, the Company entered into an amendment to the Revenue Interest Obligation (“Amended Revenue Interest Obligation”). Pursuant to the Amended Revenue Interest Obligation, the parties modified and restructured the Revenue Interest Obligation by (i) revising the annual minimum payments for 2024 and each subsequent fiscal year during the term of the agreement from $ 2.75 million to $ 4.4 million; (ii) agreeing to a payment by the Company of $ 3.0 million in satisfaction of all royalty obligations for the first three fiscal quarters of 2023, with half of such amount to be paid not later than January 20, 2024, and the remainder to be paid not later than April 10, 2024; (iii) agreeing to a payment by the Company of $ 1.1 million in satisfaction of the royalty obligations for the fourth quarter of 2023; and (iii) waiving the obligation of Elutia to make the $ 5.0 million milestone payment that became due to Ligand in the second quarter of 2023.
As of December 31, 2023, the Company recorded the present value of the estimated total future payments under the Initial Revenue Interest Obligation as a long-term obligation and the short-term portion is comprised of (i) the 2023 and 2024 minimum payments, (ii) the first $ 5.0 million sales milestone payment noted above and (iii) the unpaid portion of the 2022 minimum payments. The short-term portion as of December 31, 2022 is comprised of (i) the 2023 minimum payments, (ii) the first $ 5.0 million sales milestone payment noted above and (iii) the unpaid portion of the 2022 minimum payments.
Note 12. Fair Value Measurements
The following tables set forth by level, within the fair value hierarchy, the liabilities that are measured at fair value on a recurring basis (in thousands):
Fair Value Measurements at December 31, 2022 Using:
Level 1
Level 2
Level 3
Total
Liabilities:
Revenue Interest Obligation*
$
—
$
—
$
14,906
$
14,906
Total
$
—
$
—
$
14,906
$
14,906
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Fair Value Measurements at December 31, 2023 Using:
Level 1
Level 2
Level 3
Total
Assets:
Money market fund
$
14,087
$
—
$
—
$
14,087
Total
$
14,087
$
—
$
—
$
14,087
Liabilities:
Revenue Interest Obligation*
$
—
$
—
$
17,101
$
17,101
Warrant liability
—
—
12,760
12,760
Total
$
—
$
—
$
29,861
$
29,861
*Net Present Value; see discussion of value below
The warrant liability in the table above consisted of the fair value of Offering Warrants (as defined in Note 14 below) to purchase the Company’s Class A Common Stock and was based on significant inputs not observable on the market, which represents a Level 3 measurement within the fair value hierarchy. See Note 14 for discussion of the Company’s valuation methods and related impacts on the consolidated statement of operations with respect to the warrant liability.
The Company has estimated the value of the Initial Revenue Interest Obligation as of December 31, 2023 and 2022, including contingent milestone payments and estimated sales-based payments, based on assumptions related to future sales of the acquired products. 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. There was no change to estimated future payments during the year ended December 31, 2023 and thus, no re-measurement gain or loss was recognized.
In connection with our estimation at December 31, 2022, it was determined that the estimated future payments, discounted at the original discount rate, had decreased since the prior estimates. Such decrease was primarily the result of anticipated changes to our strategic partnerships relative to sales of both our CanGaroo and cardiovascular product lines that were expected to impact the timing and extent of such sales and, thereby, were expected to reduce expected future payments to Ligand. The change to estimated future payments yielded a reduction to the total Revenue Interest Obligation of approximately $ 5.0 million for the year ended December 31, 2022 with such amount recognized as a gain in other expense (income), net in our consolidated statement of operations.
The following table provides a rollforward of the aggregate fair value of the Revenue Interest Obligation and warranty liability categorized with Level 3 inputs for the years ended December 31, 2023 and 2022 (in thousands):
Revenue Interest Obligation
Warranty Liability
Balance as of January 1, 2022
$
19,290
$
—
Payments on Revenue Interest Obligation
( 2,075 )
—
Interest accrued to Revenue Interest Obligation
2,653
—
Gain on revaluation of revenue interest obligation
( 4,962 )
—
Balance as of December 31, 2022
$
14,906
$
—
Payments on Revenue Interest Obligation
—
—
Interest accrued to Revenue Interest Obligation
2,195
—
Gain on revaluation of revenue interest obligation
—
—
Fair value adjustment to warrant liability
—
12,760
Balance as of December 31, 2023
$
17,101
$
12,760
Note 13. Income Taxes
The Company is subject to income taxes in the United States. Income taxes are accounted for under the asset and liability method. Deferred income tax assets and liabilities are calculated based on the difference between the financial
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statement carrying amounts of existing assets and liabilities and their respective tax bases using the enacted income tax rates expected to be in effect during the years in which the temporary differences are expected to reverse.
The reconciliation of the U.S. federal statutory rate to the consolidated effective tax rate is as follows:
Years Ended December 31,
2023
2022
Tax benefit at U.S. statutory rate
21.0
%
21.0
%
State income tax benefit, net of federal benefit
1.8
%
1.9
%
Nondeductible expenses
( 2.8 )
%
( 0.3 )
%
State law changes
0.6
%
0.5
%
Other
( 1.4 )
%
0.1
%
Change in valuation allowance
( 19.3 )
%
( 23.3 )
%
Income tax expense
( 0.1 )
%
( 0.1 )
%
Deferred income taxes reflect the net tax effects of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes as well as net operating loss carryforwards. As of December 31, 2023 and 2022, significant components of the Company’s net deferred income taxes are as follows (in thousands):
December 31,
2023
2022
Deferred tax assets:
Tax goodwill
$
2,613
$
2,947
Net operating loss carryforwards
23,325
19,743
Inventory
137
491
Acquired intangibles
1,734
1,452
Revenue interest obligation
1,220
774
Interest expense
3,510
2,533
Research and development costs
2,412
1,749
Operating lease liability
52
364
FiberCel litigation costs
2,867
669
Other
1,653
2,045
Total assets
39,523
32,767
Deferred tax liabilities:
Operating lease right-to-use assets
( 51 )
( 350 )
Prepaid expenses
( 484 )
( 562 )
Total liabilities
( 535 )
( 912 )
Total net deferred tax asset
38,988
31,855
Valuation allowance
( 38,988 )
( 31,855 )
Net deferred tax asset, net of valuation allowance
$
—
$
—
The Company did not recognize any deferred benefit for income taxes for the years ended December 31, 2023 and 2022, as the increases to the respective net deferred tax assets of $ 7.1 million and $ 7.6 million, respectively, were offset by corresponding increases to the Company’s deferred tax asset valuation allowance due to uncertainty of realizing the deferred tax assets.
The Company evaluates the need for deferred tax asset valuation allowances based on a more likely than not standard. The ability to realize deferred tax assets depends on the ability to generate sufficient taxable income within the carryback or carryforward periods provided for in the tax law for each applicable tax jurisdiction. Valuation allowances are established when necessary to reduce deferred tax assets to amounts that are more likely than not to be realized. Based on the uncertainty of future taxable income generation, as of December 31, 2023 and 2022, the Company has provided valuation allowances against all deferred tax assets.
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The Company regularly assesses the realizability of its deferred tax assets. Changes in historical earnings performance and future earnings projections, among other factors, may cause the Company to adjust its valuation allowance, which would impact the Company’s income tax expense in the period the Company determines that these factors have changed.
The income tax expense for the years ended December 31, 2023 and 2022 relates to current amounts due on certain state tax obligations.
As of December 31, 2023, the Company had net operating loss carryforwards for federal income tax purposes of approximately $ 102.1 million, comprised of $ 17.7 million that will expire beginning in 2036 and $ 84.4 million that have no expiration date. The Company also had state net operating loss carryforwards of approximately $ 33.5 million that will expire beginning in 2030. Utilization of the net operating loss carryforwards may be subject to an annual limitation under Section 382 of the Code, and corresponding provisions of state law, due to ownership changes that have occurred previously or that could occur in the future. These ownership changes may limit the amount of carryforwards that can be utilized annually to offset future taxable income. The Company has not conducted a study to assess whether a change of control has occurred or whether there have been multiple changes of control since inception due to the significant complexity and cost associated with such a study. If the Company has experienced a change of control, as defined by Section 382, at any time since inception, utilization of the net operating loss carryforwards would be subject to an annual limitation under Section 382. Any limitation may result in expiration of a portion of the net operating loss carryforwards before utilization.
As of December 31, 2023 and 2022, the Company had no unrecognized tax benefits.
Note 14. Common Stock and Warrants
Private Placement of Common Stock and Warrants
On September 21, 2023, the Company sold, in a private offering an aggregate of (i) 6,852,811 units (“Common Units”) each comprised of (a) one share of the Company’s Class A common stock and (b) a warrant (“Common Warrant”) to purchase one and one half shares of Class A Common Stock, and (ii) 503,058 units (the “Prefunded Units”), each comprised of (a) a prefunded warrant (“Prefunded Warrant”) to purchase one share of Class A Common Stock, and (b) a Common Warrant. The Common Units were sold at a purchase price of $ 1.4275 per unit, and the Prefunded Units were sold at a purchase price of $ 1.4265 per unit, for aggregate gross proceeds of approximately $ 10.5 million, before deducting offering expenses. Each Common Warrant is exercisable at any time until the earlier of (a) 30 trading days after the clearance by the FDA of the Company’s CanGarooRM antibiotic-eluting biologic envelope or (b) five years from the date of the offering, at an exercise price per share of $ 1.4275 . Each Prefunded Warrant is exercisable at any time at a nominal exercise price per share of $ 0.001 (with the remainder of the exercise price per share of Class A Common Stock having been prefunded to the Company).
The Company incurred transaction fees, including commissions and legal fees, of approximately $ 1.1 million in connection with the private placement, of which $ 0.4 million were allocated to the issuance of the common stock. See below for discussion of the accounting for warrants and the allocation of the remainder of the transaction fees.
Warrant Liabilities
The Company has concluded that the Common Warrants and the Prefunded Warrants (collectively, the “Offering Warrants”) do not meet the equity contract scope exception under ASC 815-40 as in the event of a (i) fundamental transaction such as a merger and (ii) failure to timely delivery warrant shares upon exercise, certain provisions may require the Company to adjust the settlement value that is not consistent with a fixed-for-fixed option pricing model. As a result, as of the September 21, 2023 issuance date, the Company allocated $ 8.6 million of the gross proceeds from the offering to the Offering Warrants based on their fair value, and the remaining $ 1.9 million was allocated to the common shares and recorded as permanent equity. The liability associated with the Offering Warrants is recorded as warrant liability in the accompanying consolidated balance sheet as of December 31, 2023.
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The valuation of the Offering Warrants is adjusted to fair value (Level 3) at each subsequent balance sheet date until the warrants are settled. To this end, due primarily to fluctuations in the Company’s underlying common stock price between the issuance date of the Offering Warrants and December 31, 2023, the warrant liability was revalued to $ 12.8 million as of December 31, 2023. The change in fair value of $ 4.2 million has been recorded as other expense (income), net in the accompanying consolidated statements of operations for the year ended December 31, 2023.
The Company also allocated a portion of the transaction fees noted above to the Offering Warrants and expensed within other expense (income), net, approximately $ 0.7 million of these fees.
The Company calculated the fair value of the Offering Warrants using the Black-Scholes option pricing model with the following inputs:
September 21, 2023
December 31, 2023
Common stock price
$
1.53
$
2.16
Expected term (years)
0.9
0.7
Risk-free interest rate
5.5
%
5.1
%
Volatility factor
117.4
%
107.3
%
Dividend yield
—
%
—
%
The expected term of the Offering Warrants is based on a significant unobservable input, the Company’s probability-weighted expectations relative to the timing of the clearance by the U.S. Food & Drug Administration of the Company’s CanGarooRM antibiotic-eluting biologic envelope.
Public Offering of Common Stock
On December 1, 2022, the Company issued and sold 2,350,000 shares of its Class A common stock at a price to the public of $ 4.75 per share in a registered underwritten public offering, resulting in net proceeds to the Company of approximately $ 10.2 million, after deducting underwriting discounts and offering expense.
Note 15. Retirement Plan
The Company has a defined contribution savings plan under section 401(k) of the Internal Revenue Code. The plan covers substantially all employees. The Company matches employee contributions made to the plan according to a specified formula. The Company’s matching contributions totaled approximately $ 0.3 million for both the years ended December 31, 2023 and 2022.
In June 2022, our former President and Chief Executive Officer, in connection with his resignation from the Company, entered into a separation agreement pursuant to which he remained a full-time, non-officer employee of the Company through September 30, 2022 to assist with the transition of his duties to his successor. On September 30, 2022, our former President and Chief Executive Officer received: (i) cash severance in an amount equal to his base salary for a period of 12 months and 100 % of his annual target bonus and (ii) the COBRA benefits, during the 12-month period following September 30, 2022. The Company recognized these severance costs totaling approximately $ 1.0 million over the period from June 21, 2022 through September 30, 2022, and as of December 31, 2022, all such expenses remaining to be paid were included in Accrued Expenses in the accompanying consolidated balance sheets.
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Note 16. Net Loss Per Share
Year Ended
(in thousands, except share and per share data)
December 31,
2023
2022
Numerator:
Net loss from continuing operations
$
( 41,249 )
$
( 36,182 )
Net income from discontinued operations
$
3,593
$
3,285
Net loss
$
( 37,656 )
$
( 32,897 )
Denominator:
Weighted average number of common shares - basic and diluted
18,160,822
13,832,887
Net loss per share from continuing operations attributable to common stockholders - basic and diluted
$
( 2.27 )
$
( 2.62 )
Net income per share from discontinued operations attributable to common stockholders - basic and diluted
$
0.20
$
0.24
Net loss per share - basic and diluted
$
( 2.07 )
$
( 2.38 )
The Company’s potential dilutive securities have been excluded from the computation of diluted net loss per share as the effect would be anti-dilutive. Therefore, the weighted average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. The Company excluded the following potential common shares, presented based on amounts outstanding at period end, from the computation of diluted net loss per share attributable to common stockholders:
December 31,
2023
2022
Options to purchase common stock
1,501,193
1,864,739
Restricted stock units
335,608
372,307
Class A common stock warrants
187,969
187,969
Common Warrants
11,033,804
—
Prefunded Warrants
503,058
—
Total
13,561,632
2,425,015
Note 17. Commitment and Contingencies
Cook Biotech License and Supply Agreements
Elutia has entered into a license agreement with Cook Biotech Incorporated (“Cook Biotech”) for an exclusive, worldwide license to the porcine tissue for use in the Company’s Cardiovascular and CanGaroo products, subject to certain co-exclusive rights retained by Cook Biotech. The term of such license is through the date of the last to expire of the licensed Cook Biotech patents, which is anticipated to be July 2031. Along with this license agreement, Elutia entered into a supply agreement whereby Cook Biotech would be the exclusive supplier to Elutia of the licensed porcine tissue. Under certain limited circumstances, Elutia has the right to manufacture the licensed product and pay Cook Biotech a royalty of 3 % of sales of the Elutia-manufactured tissue. The supply agreement expires on the same date as the related license agreement. No royalties were paid to Cook Biotech during the years ended December 31, 2023 and 2022. Elutia has also entered into an amendment to the Cook Biotech license agreement (the “Cook Biotech Amendment”) in order to add fields of exclusive use. Specifically, the Cook Biotech Amendment provides for a worldwide exclusive license to the porcine tissue for use with neuromodulation devices in addition to cardiovascular devices. The Cook Amendment includes license fee payments of $ 0.1 million per year in each of the years 2021 through 2026. Such license payments would accelerate if a change in control, as defined, occurs within Elutia. The Company, in its sole discretion, can terminate the license agreement at any time.
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In February 2024, it was announced that Cook Biotech was acquired by RTI Surgical, Inc. The Company does not expect the acquisition to affect its supply agreement with Cook Biotech, which the Company understands will continue as a subsidiary of RTI Surgical.
Legal Proceedings
From time to time, the Company may be involved in claims and proceedings arising in the course of the Company’s business. The outcome of any such claims or proceedings, regardless of the merits, is inherently uncertain. The Company records accruals for contingencies when it is probable that a liability has been incurred and the amount can be reasonably estimated. Where the available information is only sufficient to establish a range of probable liability, and no point within the range is more likely than any other, the lower end of the range has been used. When a material loss contingency is reasonably possible, but not probable, the Company does not record a liability, but instead discloses the nature of the matter and an estimate of the loss or range of loss, to the extent such estimate can be made. Accruals recorded are adjusted periodically as assessments change or additional information becomes available, and management's judgments may be materially different than the actual outcomes.
FiberCel Litigation
In June 2021, the Company announced a voluntary recall of a single lot of FiberCel fiber viable bone matrix. Since September 2021, 109 lawsuits or claims have been filed or asserted against the Company. The lawsuits, which have been filed against Elutia, certain Medtronic entities, and others, allege that the plaintiffs were exposed to and/or contracted tuberculosis and/or suffered substantial symptoms and complications following the implantation of FiberCel during orthopedic fusion operations. Such lawsuits were filed in Indiana state court (collectively, the “Indiana State Complaints”); the Superior Court of the State of Delaware (collectively, the “Delaware State Complaints”); the Circuit Court of Maryland (collectively, the “Maryland State Complaints”); the Court of Common Pleas of Ohio (the “Ohio State Complaint”); the U.S. District Court of the Southern District of Ohio (the “Ohio Federal Complaint”); the U.S. District Court for the Western District of North Carolina (“North Carolina Federal Complaint”); the Circuit Court of Florida, and the U.S. District Court for the Northern District and the Southern District of Florida (collectively, the “Florida Complaints”); U.S. District Court for the Eastern District of Michigan (collectively “Michigan Federal Complaints.”); the U.S. District Court for the District of Colorado (“Colorado Federal Complaint”); the U.S. District Court for the District of Oregon (“Oregon Federal Complaint”); the Fayette, Kentucky Circuit Court and the U.S. District Court for the Eastern District of Kentucky (collectively, “Kentucky Complaints.”); the U.S. District Court for the Western District of Louisiana (“Louisiana Federal Complaint”);the Circuit Court of Cook County, Illinois and the U.S. District Court for the Northern District of Illinois (collectively, the “Illinois Complaints”); the U.S. District Court for the Eastern District of Pennsylvania (“Pennsylvania Federal Complaint); the U.S. District Court for the Eastern District of Virginia (“Virginia Federal Complaint”); the U.S. District Court for the Central District of California (“California Federal Complaint”); and the U.S. District Court of Arizona (“Arizona Federal Complaint").
Plaintiffs in the Indiana State Complaints allege a cause of action under Indiana’s Product Liability Act, citing manufacturing defects, defective design and failure to properly warn and instruct, and several of the complaints allege loss of consortium. Plaintiffs in these actions assert that the defendants are strictly liable or have breached the duty of care owed to plaintiffs by failing to exercise reasonable care in designing, manufacturing, marketing and labeling FiberCel and are seeking various types of damages, including economic damages, non-economic damages and loss of consortium. Plaintiffs in one of the Indiana State Complaints allege causes of action for product liability, negligence, breach of express and implied warranties, and punitive damages. Each of the plaintiffs in the Delaware State Complaints alleges negligence, breach of implied warranty, breach of express warranty, and medical monitoring and punitive damages, and two also allege loss of consortium. Plaintiffs in the Delaware State Complaints are seeking economic, consequential, and punitive damages. The Maryland State Complaints assert claims of negligence, breach of implied warranty, breach of express warranty, medical monitoring, and loss of consortium. The Florida Complaints contain three strict liability claims for defective design, defective manufacture, and failure to warn. A claim for punitive damages is also pled. The Ohio State Complaint alleges causes of action for product liability and negligence and seeks compensatory damages. The Colorado Federal Complaint asserts causes of action for strict product liability, misrepresentation, negligence, breach of express warranty, and breach of implied warranty of merchantability. The Michigan Federal Complaints assert causes of action for negligence, gross negligence breach of implied warranty, breach of express warranty, intentional infliction of emotional
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distress, and liability under the res ipsa loquitur doctrine. The Michigan Federal Complaints seek compensatory damages and punitive damages. The North Carolina Federal Complaint alleges causes of action for negligence, defective design, breach of implied warranty, breach of express warranty, and loss of consortium, and seeks both compensatory and punitive damages. The Oregon Federal Complaint asserts strict liability claims for defective design, defective manufacture, and failure to warn, and seeks compensatory damages. The Ohio Federal Complaint asserts strict liability claims for defective manufacturing, inadequate warning, nonconformance with representations, and also alleges loss of consortium and seeks compensatory damages. The Kentucky Complaints assert strict liability claims based on manufacturing defect, design defect, failure to warn, negligence, breach of implied warranty, breach of express warranty, and seek recovery for medical monitoring, loss of consortium, compensatory damages, and punitive damages. The Louisiana Federal Complaint asserts claims of violation of the Louisiana products liability act, negligence and gross negligence, breach of implied warranty, breach of express warranty and seek recovery for medical monitoring. The Illinois Complaints contain claims of strict liability, defective design and manufacturing, breach of express warranty, breach of implied warranty and negligence and seek compensatory damages. Plaintiff in the Pennsylvania Federal Complaint asserts claims for strict liability, negligence, breach of implied warranty, and breach of express warranty, as well as claims under the Wrongful Death Act and the Survival Act and seeks compensatory and punitive damages. The Virginia Federal Complaint asserts causes of action for negligent failure to warn, negligence, breach of implied warranty, breach of express warranty and seeks recovery for medical monitoring, compensatory damages and punitive damages. The California Federal Complaint advances claims of strict liability (defective design and manufacture), negligence and breach of implied warranty and seeks compensatory damages and recovery for medical monitoring. The Arizona Federal Complaint asserts strict product liability claims for defective design, manufacture and failure to warn, negligence, breach of implied warranty and breach of express warranty and seeks recovery for medical monitoring, loss of consortium, compensatory damages, and punitive damages.
The Company refers to all of the aforementioned litigation, or claim notices, collectively as the “FiberCel Litigation.”
Since August 2022, the Company has engaged in a process to negotiate and attempt to resolve many of the cases in the FiberCel Litigation. In total, Elutia’s liability in 29 of the cases was settled for a total cash outlay of approximately $ 9.1 million. For the remaining 80 cases for which settlements have not been reached, the Company estimated a probable loss related to each case and has recorded a liability at an estimated amount of $ 15.0 million at December 31, 2023, which is recorded as Contingent liability for FiberCel litigation in the accompanying consolidated balance sheets. In order to reasonably estimate the liability for the unsettled FiberCel Litigation cases, the Company, along with outside legal counsel, has assessed a variety of factors, including (i) the extent of the injuries incurred, (ii) recent experience on the settled claims, (iii) settlement offers made to the other parties to the litigation and (iv) any other factors that may have a material effect on the FiberCel Litigation. While the Company believes its estimated liability to be reasonable, the actual loss amounts are highly variable and are dependent upon the relevant facts and case by case resolutions. As more information is learned about asserted claims and potential future trends, adjustments may be made to this Contingent Liability for FiberCel Litigation as appropriate. Management believes that it is reasonably possible that the Company could incur liabilities in excess of amounts accrued and the ultimate liability could be material to the results of operations and the cash flows in the period recognized. The Company, however, is unable to estimate the possible loss or range of loss in excess of the amount recognized at this time.
Defense costs are recognized in the accompanying consolidated statements of operations as incurred.
The Company has purchased insurance coverage that, subject to common contract exclusions, provided coverage for the FiberCel Litigation product liability losses as well as legal defense costs. Additionally, the Company has various potential indemnity and/or contribution rights against third party sources with respect to certain product liability losses. When settlements are reached and/or amounts are recorded in the related Contingent Liability for FiberCel Litigation, the Company calculates amounts due to be reimbursed pursuant to the terms of the coverage and related agreements, and pursuant to other indemnity or contribution claims, in respect of product liability losses and related defense costs. The amounts probable of reimbursement or recovery from this calculation are recorded as receivables. The determination that the recorded receivables are probable of collection is based on the terms of agreements reached in respect of indemnity and contribution claims as well as the advice of the Company’s outside legal counsel. These receivables at December 31, 2023 totaled $ 2.7 million and are recorded as Receivables of FiberCel Litigation Costs in the accompanying consolidated balance sheets.
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The indemnity and contribution receivables amount at December 31, 2023 represents amounts that are not believed to be subject to any current dispute. At December 31, 2023, the Company continues to pursue up to $ 3.8 million or more in additional amounts in respect of such indemnity and contribution claims and as such, has not been reflected as part of this receivable. The Company will vigorously pursue its position with respect to this amount.
Viable Bone Matrix Recall
In July 2023, the Company announced a voluntary recall of a single lot of a certain viable bone matrix (“VBM”) product and the market withdrawal of all of its VBM products produced after a specified date (the “VBM Recall”). Notice of the voluntary recall was issued to centers after the Company learned of post-surgical Mycobacterium tuberculosis (“MTB”) infections in two patients treated with a VBM product from a single donor lot. Prior to release, samples from this specific lot had tested negative for MTB by an independent laboratory using a nucleic acid test that is designed to specifically detect the MTB organism. At present, two lawsuits have been filed, and 15 claims have been asserted as a result of the VBM Recall.
Management has determined that there is a reasonably possible likelihood of material claims due to the VBM Recall, but does not believe that an estimate of the loss or range of loss can be made. This is mainly due to the early stages of the lawsuits and claims and the lack of receipt by the Company of the medical records needed to assess any possible loss. Consequently, management has determined that no probable liability for such possible claims would be recognized for the VBM Recall as of December 31, 2023. While unknown at this time, possible losses in connection with the VBM Recall could have a material effect on the Company’s financial position and results of operations. Consistent with the FiberCel Litigation above, the Company has purchased insurance coverage that, subject to common contract exclusions, provide coverage for the possible claims associated with the VBM Recall as well as legal defense costs. As of December 31, 2023, the Company has recorded a legal fee liability and related insurance receivable totaling $ 0.1 million for legal services rendered in defending Elutia in the VBM Recall.
As of both December 31, 2023 and 2022, the Company was not a party to, or aware of, any legal matters or claims with material financial exposure, except for the FiberCel Litigation and the VBM Recall.
Note 18. Segment Information
With the divestiture of the Orthobiologics Business, the Company now operates in three segments. These segments are based on financial information that is utilized by the Company’s CODM to assess performance and allocate resources. This financial information does not include the assets by segment. The Company determined its operating and reportable segments to be consistent with its major product groupings – Device Protection, Women’s Health and Cardiovascular.
For the years ended December 31, 2023 and 2022, the Company’s net sales disaggregated by segment were as follows (in thousands):
Year Ended December 31,
2023
2022
Net sales:
Device protection
$
9,401
$
9,093
Women's health
10,304
7,474
Cardiovascular
5,040
7,282
Total Net Sales
$
24,745
$
23,849
The net sales above include the revenues derived from one customer which represents 10 % of total net sales. Such customer is included within the Cardiovascular segment.
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For the years ended December 31, 2023 and 2022, the Company’s gross profit disaggregated by segment was as follows (in thousands):
Year Ended
December 31,
2023
2022
Gross profit:
Device protection
$
6,565
$
6,114
Women's health
4,402
3,137
Cardiovascular
3,484
5,785
Gross profit, excluding intangible asset amortization
14,451
15,036
Intangible asset amortization expense
3,398
3,397
Gross profit
$
11,053
$
11,639
The following table is a reconciliation of segment gross profit to the consolidated loss before provision for income taxes for the years ended December 31, 2023 and 2022 (in thousands):
Year Ended
December 31,
2023
2022
Gross profit, excluding intangible asset amortization
$
14,451
$
15,036
Adjustments:
Intangible asset amortization expense
( 3,398 )
( 3,397 )
Sales and marketing
( 13,087 )
( 17,850 )
General and administrative
( 14,104 )
( 16,051 )
Research and development
( 4,399 )
( 7,727 )
FiberCel litigation costs, net
( 9,989 )
( 5,200 )
Loss from operations
( 30,526 )
( 35,189 )
Interest expense
5,796
5,118
Other expense (income), net
4,899
( 4,159 )
Loss before provision for income taxes
$
( 41,221 )
$
( 36,148 )
During the years ended December 31, 2023 and 2022, the Company did not have any international product sales to specific countries where such country-specific sales represented material product sales, and the Company did not own any long-lived assets outside the United States.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.