0001104659-25-046155.txt : 20250508 0001104659-25-046155.hdr.sgml : 20250508 20250508162547 ACCESSION NUMBER: 0001104659-25-046155 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 17 CONFORMED PERIOD OF REPORT: 20250508 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Unregistered Sales of Equity Securities ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20250508 DATE AS OF CHANGE: 20250508 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ELUTIA INC. CENTRAL INDEX KEY: 0001708527 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] ORGANIZATION NAME: 03 Life Sciences EIN: 474790334 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-39577 FILM NUMBER: 25926674 BUSINESS ADDRESS: STREET 1: 12510 PROSPERITY DRIVE STREET 2: SUITE 370 CITY: SILVER SPRING STATE: MD ZIP: 20904 BUSINESS PHONE: 240-247-1143 MAIL ADDRESS: STREET 1: 12510 PROSPERITY DRIVE STREET 2: SUITE 370 CITY: SILVER SPRING STATE: MD ZIP: 20904 FORMER COMPANY: FORMER CONFORMED NAME: AZIYO BIOLOGICS, INC. DATE OF NAME CHANGE: 20170605 8-K 1 tm2514493d1_8k.htm FORM 8-K
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): May 8, 2025

 

ELUTIA INC.

(Exact name of registrant as specified in its charter)

 

Delaware   001-39577   47-4790334

(State or other jurisdiction
of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

12510 Prosperity Drive, Suite 370, Silver Spring, MD 20904

(Address of principal executive offices) (Zip Code)

 

(240) 247-1170 

(Registrant’s telephone number, including area code)

 

N/A

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) 
   
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) 
   
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) 

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Class A Common Stock, $0.001 par value per share   ELUT   The Nasdaq Capital Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company x

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

 

 

 

Item 1.01Entry into a Material Definitive Agreement

 

Ligand Royalty Agreement Amendment

 

In 2017, Elutia Med LLC (“Elutia Med”), a wholly owned subsidiary of Elutia Inc. (the “Company” or “Elutia”) and Ligand Pharmaceuticals Incorporated (“Ligand”) entered into that certain royalty agreement dated as of May 31, 2017, as amended effective as of January 10, 2024 (the “Royalty Agreement”). The Royalty Agreement requires Elutia Med to pay Ligand 5.0% of future sales of the CanGaroo, ProxiCor, Tyke and VasCure products, and substantially similar products, such as EluPro, through May 31, 2027, subject to annual minimum payments of $4.4 million. Furthermore, a $5.0 million payment will be due if cumulative sales exceed $300 million or the assets related to CanGaroo and any substantially similar products undergo a change of control during the ten-year term of the agreement, which expires on May 31, 2027.

 

On May 8, 2025, the Company, Elutia Med and Ligand entered into a subscription agreement and amendment no. 2 (the “Ligand Amendment”) to the Royalty Agreement. The Ligand Amendment provides that $2.2 million in outstanding royalty obligations owed by Elutia Med to Ligand under the Royalty Agreement will be satisfied by the issuance of 1,105,528 shares of Elutia’s Class A Common Stock (the “Shares”) to Ligand in a transaction registered with the U.S. Securities and Exchange Commission (the “SEC”). The royalty obligations being satisfied through the issuance of Shares consist of all unpaid and accrued royalty payments under the Royalty Agreement as of May 8, 2025, the date of execution of the Ligand Amendment, including monthly royalties, minimum quarterly royalties and minimum annual royalties, all as such terms are defined in the Royalty Agreement. Such obligations would otherwise have had to been paid in cash.

 

The number of Shares issued was determined by dividing royalty obligations of $2.2 million by $1.99, which is the average Nasdaq Official Closing Price of the Shares (as reflected on Nasdaq.com) for the five trading days immediately preceding May 8, 2025, the day the Ligand Amendment was executed. The Ligand Amendment does not amend, modify or otherwise affect Elutia Med’s royalty obligations under the Royalty Agreement with respect to the fiscal quarters ending June 30, 2025 and thereafter.

 

The Shares were offered by the Company pursuant to a prospectus supplement to the registration statement on Form S-3 (File No. 333-285870) originally filed on March 18, 2025, with the SEC under the Securities Act of 1933, as amended (the “Securities Act”), and declared effective on April 7, 2025.

 

The foregoing description of the material terms of the Ligand Amendment is not complete and is qualified in its entirety by reference to the full text of the Ligand Amendment, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025.

 

The legal opinion, including the related consent, of Kilpatrick Townsend & Stockton LLP relating to the legality of the issuance and sale of Shares is filed as Exhibit 5.1 to this Current Report.

 

SWK Facility Amendment

 

On May 7, 2025, the Company entered into a Fourth Amendment (the “SWK Amendment”) to that certain Credit Agreement, dated as of August 10, 2022, by and among the Company, as Borrower, SWK Funding LLC, as Agent, and the lenders from time to time party thereto (the “Lenders”) (as amended and supplemented from time to time, the “SWK Facility”). The SWK Facility provides for a senior secured term loan in an aggregate amount of $25.0 million. The SWK Amendment, among other things: (i) allows for 100% of the interest payment due and owing in May 2025 to be paid in kind, (ii) removed mandatory repayment obligations related to non-ordinary course asset sales (any of such non-ordinary course asset sales to be approved in advance by the Lenders), (iii) allows the Company to request the Lender to advance a new term loan in the amount of up to $5.0 million, which advance will be in the sole and absolute discretion of the Lenders, (iv) fixed the amount of the minimum consolidated unencumbered liquid assets covenant to be at least $8.0 million and (v) provided a pathway for the Company and the Agent to negotiate in good faith modifications to the repayment provisions in the event that there is a material issuance by the Company of subordinated debt or equity interests.

 

 

 

 

In consideration for the SWK Amendment, the Company has agreed to issue the Lenders 50,000 shares of its Class A Common Stock in a transaction exempt from registration pursuant to Section 4(a)(2) under the Securities Act as a transaction by an issuer not involving a public offering and/or Regulation D promulgated thereunder.

 

The foregoing description of the material terms of the SWK Amendment is not complete and is qualified in its entirety by reference to the full text of the SWK Amendment, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025.

 

Item 2.02Results of Operations and Financial Condition.

 

On May 8, 2025, the Company issued a press release announcing its results for the first quarter ended March 31, 2025. A copy of the Company’s press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

The information in this Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Item 3.02Unregistered Sales of Equity Securities

 

The information contained in Item 1.01 of this Current Report on Form 8-K under the heading “SWK Facility Amendment” is incorporated by reference into this Item 3.02.

 

Item 9.01Financial Statements and Exhibits.

 

(d)Exhibits.

 

Exhibit No.   Exhibit Description
     
5.1   Opinion of Kilpatrick Townsend & Stockton LLP
     
23.1   Consent of Kilpatrick Townsend & Stockton LLP (included in Exhibit 5.1)
     
99.1   Press Release of Elutia Inc., dated May 8, 2025
     
104   Cover Page Interactive Data File (formatted as Inline XBRL document)

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  ELUTIA INC.
  (Registrant)
   
     
Date: May 8, 2025 By:  /s/ Jeffrey Hamet
    Jeffrey Hamet
    Senior Vice President of Finance

 

 

 

EX-5.1 2 tm2514493d1_ex5-1.htm EXHIBIT 5.1

 

Exhibit 5.1

 

  Kilpatrick Townsend & Stockton LLP
ktslaw.com
Suite 2800, 1100 Peachtree Street NE
Atlanta, GA 30309-4528

 

May 8, 2025

 

Elutia Inc.

12510 Prosperity Drive

Suite 370

Silver Spring, MD 20904

 

Re:      Amendment No. 2 to Royalty Agreement and Issuance of Common Stock

 

Ladies and Gentlemen:

 

We have acted as counsel to Elutia Inc., a Delaware corporation (“Elutia” or the “Company”), in connection with the issuance of 1,105,528 shares its Class A Common Stock, par value $0.001 per share (the “Shares”). The Shares are being issued pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-285870) (the “Registration Statement”) filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025 under the Securities Act of 1933, as amended (the “Securities Act”), the base prospectus included in the Registration Statement (the “Base Prospectus”) and the prospectus supplement related to the Shares (together with the Base Prospectus, the “Prospectus”).

 

The Prospectus relates to the second amendment (“Amendment No. 2”) to that certain Royalty Agreement, dated May 31, 2017, as amended by Amendment No. 1 thereto effective as of January 10, 2024 (as so amended, the “Royalty Agreement”) regarding the issuance of the Shares to Ligand Pharmaceuticals Incorporated, a Delaware corporation (“Ligand”), as payment of royalty fees owed by Elutia Med LLC, a subsidiary of Elutia , in lieu of a cash payment.

 

Subject to the assumptions, qualifications and limitations identified in this letter, we are of the opinion that the Shares have been duly authorized for issuance and, when issued and paid for as described in Amendment No. 2, the Registration Statement and Prospectus, will be validly issued, fully paid and nonassessable.

 

In connection with the preparation of this letter, we have among other things reviewed: (i) the Registration Statement and Prospectus, including the filings incorporated by reference therein; (ii) the Notice of Effectiveness with respect to the Registration Statement filed by the SEC on April 7, 2025; (iii) the Royalty Agreement, including Amendment No. 2 thereto; (iv) copies of minutes, resolutions and consents, as applicable, of the Board of Directors and committees of the Board of Directors of the Company related to the offering, certified by an officer of the Company; (v) the Restated Certificate of Incorporation of the Company, as amended, as certified by the Secretary of State of the State of Delaware on January 31, 2025; (vi) the Second Amended and Restated Bylaws of the Company, certified by an officer of the Company; (vii) a certificate of good standing from the Secretary of State of the State of Delaware dated May 8, 2025; and (viii) such other certificates, documents and instruments we have deemed appropriate for purposes of this letter.

 

Anchorage Atlanta Augusta BEIJING Charlotte CHICAGO DALLAS Denver houston los angeles New York PHOENIX Raleigh

 

San Diego San Francisco Seattle SHANGHAI Silicon Valley Stockholm Tokyo Walnut Creek Washington Winston-Salem

 

 

 

 

May 8, 2025

Page 2

 

We have assumed with your permission for purposes of this letter: (i) that each document we have reviewed is accurate and complete, each such document that is an original is authentic, each such document that is a copy conforms to an authentic original, and all signatures on each such document are genuine, and that all natural persons who have signed any documents have the legal capacity to do so; that the parties thereto (other than the Company) had the power, corporate or other, to enter into and perform all obligations thereunder; that each such document was duly authorized by all requisite corporate or other action of the parties thereto and that such documents were duly executed and delivered by each party thereto other than the Company; (ii) that each agreement we have examined for purposes of this letter has been duly authorized, executed and delivered, constitutes a valid and binding obligation of each party to that document and that each such party has satisfied all legal requirements that are applicable to such party to the extent necessary to entitle such party to enforce such agreement, and that each party to any document is in good standing and duly incorporated or organized under the laws of the state of its incorporation or organization (except that we make no assumptions pursuant to this clause (ii) with respect to the Company); (iii) that the Company will comply with all applicable notice requirements regarding uncertificated shares provided in the Delaware General Corporation Law (“DGCL”); and (iv) that the counterparties to agreements we have reviewed have acted in good faith and without notice of any fact which has caused them to reach any conclusion contrary to any of the opinions or assumptions in this letter.

 

In preparing this letter we have relied without independent verification upon: (i) information contained in certificates obtained from governmental authorities; (ii) factual information represented to be true in the agreements and documents read by us (including, without limitation, any representations and warranties of the Company and counterparties to such agreements); (iii) factual information provided to us by the Company or its representatives; and (iv) factual information we have obtained from such other sources as we have deemed reasonable. We have assumed that there has been no relevant change or development between the dates as of which the information cited in the preceding sentence was given and the date of this letter and that the information upon which we have relied is accurate and does not omit disclosures necessary to prevent such information from being misleading.

 

We are opining herein only as to DGCL.

 

This opinion has been prepared for your use in connection with the issuance of Shares in connection with the Registration Statement. We assume no obligation to advise you of any change in the foregoing subsequent to the effectiveness of the Registration Statement even though the change may affect the legal analysis or a legal conclusion or other matters in this opinion letter. This opinion may not be furnished to or relied upon by any person or entity for any purpose without our prior written consent.

 

 

 

 

May 8, 2025

Page 3

 

This opinion letter speaks only as of its date and is delivered in accordance with the requirements of Item 601(b)(5) of Regulation S-K under the Securities Act. We consent to the reference to our firm under the heading “Legal Matters” in the Prospectus and to the filing of this opinion as an exhibit to a Current Report on Form 8-K to be filed with the SEC for incorporation by reference into the Registration Statement. In giving this consent, we do not hereby admit that we come within the category of persons whose consent is required under Section 7 of the Securities Act or the rules and regulations thereunder.

 

 Sincerely,
  
/s/ KILPATRICK TOWNSEND & STOCKTON LLP

 

 

 

EX-99.1 3 tm2514493d1_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

 

Elutia Announces Strong First Quarter 2025 Financial Results Driven by 84% Sequential Growth in EluPro™ Sales

 

- New Boston Scientific distribution partnership now underway -

- Conference call today at 5:00 p.m. ET / 2:00 p.m. PT -

 

SILVER SPRING, Md., May 8, 2025 — Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix technologies, today reported strong first-quarter results for 2025 and highlighted key developments driving the adoption of EluPro™. In its first quarter post-launch, EluPro demonstrated strong momentum, establishing its position as a groundbreaking solution for cardiac implantable electronic device (CIED) procedures.

 

Business Highlights:

 

·The EluPro™ Revolution is Now Underway: In its first full quarter post-launch, EluPro experienced an 84% sequential increase, driving 31% year-over-year BioEnvelope revenue growth, totaling $3.1 million; EluPro accounted for approximately 52% of BioEnvelope sales in the quarter.

 

·Robust Market Access of EluPro: Value analysis committee (VAC) approvals now exceed 125, with hospitals actively ordering; two new GPO contracts signed in Q1 bring total coverage to seven with broad national reach.

 

·New Strategic Partnership with Boston Scientific (BSC): Expected to accelerate adoption starting in Q2 2025; Combined commercial footprint now exceeds 900 sales professionals nationwide, with BSC reps driving VAC approvals and in-procedure adoption of EluPro; Elutia captures full end-user revenue while leveraging BSC case coverage under a favorable economic model; initial training is complete and BSC is already generating sales in over 50 hospitals.

 

·EluPro Gaining Recognition Through Targeted Marketing: Prominent presence at Heart Rhythm Society 2025, launching a new national campaign: ‘Putting an End to Unnecessary Roughness – Feel the Difference Biology Makes.’

 

·Scientific Leadership Driving Credibility and Adoption: EluPro received a 2025 Edison Award for innovation in post-surgical recovery; the first patient was enrolled in the real-world outcomes study; and new peer-reviewed data further validated EluPro’s broad-spectrum antibacterial efficacy.

 

·Cardiovascular Portfolio Update: Elutia regained full commercial rights to ProxiCor™, Tyke™, and VasCure™, now sold through a lean contractor-based model expected to drive top-line growth and immediately improve cash flow.

 

·Strengthened Financial Position: Raised $15.0 million in gross proceeds through a registered direct offering; amended SWK loan terms to allow full PIK interest and potential access to an additional $5 million term loan; and revised the Ligand agreement to accept equity in lieu of cash, reducing outflows by $2.2 million in H1 2025.

 

 

 

 

“With an 84% increase in sequential sales, EluPro has exceeded expectations, and we’re just getting started,” said Dr. Randy Mills, CEO of Elutia. “We plan to supercharge this momentum through our partnership with Boston Scientific by expanding surgical case coverage and facilitating VAC approvals at scale. As demand grows, we remain laser-focused on what matters most: delivering high-quality, drug-eluting biologics that help patients thrive without compromise.”

 

First Quarter 2025 Financial Results

 

For the three-month period ended March 31, 2025, as compared to the same period of 2024:

 

·Net sales for BioEnvelope products, including both EluPro and CanGaroo, increased by 31%, totaling $3.1 million compared to $2.4 million in Q1 2024, reflecting strong and accelerating sales of EluPro.

 

·Net sales of SimpliDerm were $2.6 million, compared to $3.6 million in Q1 2024.

 

·Net sales of Cardiovascular products were $0.3 million, compared to $0.8 million in Q1 2024.

 

·Overall net sales decreased 10% to $6.0 million, compared to $6.7 million.

 

·Gross margin on a GAAP basis was 40.7%, compared to 42.5%

 

·Adjusted gross margin (a non-GAAP measure which excludes non-cash amortization of intangibles) was 54.8%, compared to 55.2%. A reconciliation of GAAP gross margin to adjusted gross margin is included in the accompanying financial tables.

 

·Total operating expenses were $10.4 million, compared to $11.3 million.

 

·Loss from operations was $7.9 million, compared to $8.5 million.

 

·Adjusted EBITDA (a non-GAAP measure that excludes from net loss certain non-operating, non-cash and non-recurring items) was a loss of $3.3 million, compared to a loss of $3.6 million. A reconciliation of net loss to adjusted EBITDA is included in the accompanying financial tables.

 

·Cash balance as of March 31, 2025, was $17.4 million.

 

Conference Call

 

Elutia will host a conference call today at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time to discuss its first quarter 2025 financial results and performance.

 

The conference call can be accessed using the following information:

 

Webcast: Click here
U.S. Investors: 877-407-8029
International Investors: 201-689-8029
Conference ID: 13753035

 

About Elutia

 

Elutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com.

 

 

 

 

Non-GAAP Disclosure

 

In addition to the Company's financial results determined in accordance with U.S. GAAP, the Company provides non-GAAP measures that it determines to be useful in evaluating its operating performance and liquidity. The Company presents in this press release the following non-GAAP financial measures: earnings before interest, taxes, depreciation and amortization (“EBITDA”), adjusted earnings before interest, taxes, depreciation and amortization (“adjusted EBITDA”), adjusted gross margin and adjusted gross profit. The Company defines EBITDA as GAAP net loss excluding interest expense, income tax expense, depreciation and amortization, and the Company defines adjusted EBITDA as EBITDA excluding stock-based compensation, FiberCel and VBM litigation costs, loss or gain on revaluation of warrant liability, warrant issuance expenses and gain on revaluation of revenue interest obligation. The Company defines adjusted gross profit and adjusted gross margin as GAAP gross profit and GAAP gross margin, respectively, excluding amortization of acquired intangible assets. The amortization of these intangible assets will recur in future periods until such intangible assets have been fully amortized. Management believes that presentation of non-GAAP financial measures provides useful supplemental information to investors and facilitates the analysis of the Company's core operating results and comparison of operating results across reporting periods. The Company uses this non-GAAP financial information to establish budgets, manage the Company's business, and set incentive and compensation arrangements. Non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental information purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with U.S. GAAP. For a reconciliation of these non-GAAP measures to GAAP, see below “Non-GAAP Reconciliations of EBITDA and Adjusted EBITDA” and “Non-GAAP Reconciliations of Adjusted Gross Profit and Adjusted Gross Margin.”

 

Forward-Looking Statements

 

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including any statements and information concerning the market reception of EluPro, including the timing and anticipated success thereof. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Such beliefs and assumptions may or may not prove to be correct. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements, including, but not limited to the following: our ability to successfully commercialize, market and sell our EluPro product; our ability to continue as a going concern; our ability to achieve or sustain profitability; the risk of product liability claims and our ability to obtain or maintain adequate product liability insurance; our ability to defend against the various lawsuits and claims related to our recalled FiberCel and other viable bone matrix products and avoid a material adverse financial consequence from those lawsuits and claims; our ability to prevail in lawsuits and claims seeking indemnity, contribution and insurance coverage for FiberCel and other viable bone matrix product liabilities; the continued and future acceptance of our products by the medical community; our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings; our dependence on our commercial partners and independent sales agents to generate a substantial portion of our net sales; our dependence on a limited number of third-party suppliers and manufacturers, which, in certain cases are exclusive suppliers for products essential to our business; our ability to successfully realize the anticipated benefits of the November 2023 sale of our Orthobiologics business; physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products; our ability to compete against other companies, most of which have longer operating histories, more established products and/or greater resources than we do; pricing pressure as a result of cost-containment efforts of our customers, purchasing groups, third-party payors and governmental organizations that could adversely affect our sales and profitability; our ability to obtain regulatory approval or other marketing authorizations by the FDA and comparable foreign authorities for our products and product candidates; our ability to obtain, maintain and adequately protect our intellectual property rights; and other important factors which can be found in the “Risk Factors” section of Elutia’s public filings with the Securities and Exchange Commission (“SEC”), including Elutia’s Annual Report on Form 10-K for the year ended December 31, 2024, as such factors may be updated from time to time in Elutia’s other filings with the SEC, including Elutia’s Quarterly Reports on Form 10-Q, accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Elutia’s website at https://investors.elutia.com. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking statement made by Elutia in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, Elutia expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

 

Investors:
Matt Steinberg
FINN Partners
matt.steinberg@finnpartners.com

 

 

 

 

ELUTIA INC.

CONSOLIDATED BALANCE SHEET DATA

(Unaudited, in thousands)

 

   March 31, 2025   December 31, 2024 
Assets          
Current assets:          
Cash  $17,358   $13,239 
Accounts receivable, net   2,860    2,276 
Inventory   4,286    3,911 
Receivables of litigation costs   3,893    4,760 
Prepaid expense and other current assets   1,620    1,986 
Total current assets   30,017    26,172 
Property and equipment, net   1,031    773 
Intangible assets, net   7,424    8,273 
Operating lease right-of-use assets, and other   826    909 
Total assets  $39,298   $36,127 
           
Liabilities and Stockholders' Deficit          
Current liabilities:          
Accounts payable and accrued expenses and other current liabilities  $10,608   $11,253 
Current portion of long-term debt   2,500    1,250 
Current portion of revenue interest obligation   5,500    4,400 
Contingent liability for legal proceedings   17,808    20,432 
Current operating lease liabilities   435    460 
Total current liabilities   36,851    37,795 
Long-term debt   21,762    22,603 
Long-term revenue interest obligation   4,735    5,490 
Warrant liability   12,089    16,076 
Other long-term liabilities   319    423 
Total liabilities   75,756    82,387 
Stockholders' equity (deficit):          
Common stock   41    35 
Additional paid-in capital   197,027    183,298 
Accumulated deficit   (233,526)   (229,593)
Total stockholders' deficit   (36,458)   (46,260)
Total liabilities and stockholders' deficit  $39,298   $36,127 

 

 

 

 

ELUTIA INC.

CONSOLIDATED STATEMENT OF OPERATIONS

(Unaudited, in thousands, except share and per share data)  

 

   Three months ended March 31, 
   2025   2024 
Net sales  $6,030   $6,694 
Cost of goods sold   3,573    3,851 
Gross profit   2,457    2,843 
Operating expenses:          
Sales and marketing   3,031    3,309 
General and administrative   3,871    5,056 
Research and development   905    1,172 
Litigation costs, net   2,572    1,785 
Total operating expenses   10,379    11,322 
Loss from operations   (7,922)   (8,479)
Interest expense   1,085    1,313 
Other (income) expense, net   (5,082)   8,194 
Loss before provision of income taxes   (3,925)   (17,986)
Income tax expense   8    8 
Net loss  $(3,933)  $(17,994)
Net loss per share - basic  $(0.10)  $(0.75)
Net loss per share - diluted  $(0.21)  $(0.75)
Weighted average common shares outstanding - basic   38,616,207    23,912,326 
Weighted average common shares outstanding - diluted   42,913,111    23,912,326 

 

 

 

 

ELUTIA INC.

NON-GAAP GROSS PROFIT AND NON-GAAP GROSS MARGIN RECONCILIATIONS

(Unaudited, in thousands, except share and per share data)

 

   Three months ended March 31, 
   2025   2024 
Net sales  $6,030   $6,694 
Gross profit   2,457    2,843 
Intangible asset amortization expense   849    849 
Adjusted gross profit (Non-GAAP)  $3,306   $3,692 
Gross margin   40.7%   42.5%
Adjusted gross margin percentage (Non-GAAP)   54.8%   55.2%

 

ELUTIA INC.

EBITDA AND ADJUSTED EBITDA RECONCILIATIONS

(Unaudited, in thousands, except share and per share data)

 

   Three months ended March 31, 
   2025   2024 
Net loss  $(3,933)  $(17,994)
Interest expense(1)   1,085    1,313 
Provision (benefit) for income taxes   8    8 
Depreciation and amortization   868    864 
Earnings before interest, taxes, depreciation and amortization (“EBITDA”) (Non-GAAP)   (1,972)   (15,809)
Stock-based compensation   1,211    2,197 
Litigation costs, net(2)   2,572    1,785 
(Gain) loss on revaluation of warrant liability(3)   (5,187)   9,636 
Warrant issuance expenses   105    - 
Gain on revaluation of revenue interest obligation(4)   -    (1,442)
Adjusted EBITDA (Non-GAAP)  $(3,271)  $(3,633)

 

(1) Represents interest expense recorded on all outstanding long-term debt as well as the revenue interest obligation.
(2) Represents litigation costs consisting primarily of legal fees and the estimated and actual costs to resolve the outstanding FiberCel and VBM litigation cases offset by the amounts recovered and recoverable under insurance, indemnity and contribution agreements for such costs.
(3) Represents non-cash expense attributable to the revaluation of Common Warrants and Prefunded Warrants issued in connection with a private offering in September 2023 and registered direct offerings in June 2024 and February 2025
(4) Represents the gain on the revaluation of the revenue interest obligation. At each reporting period, the value of the revenue interest obligation is re-measured based on current estimates of future payments, with changes to be recorded in the consolidated statements of operations using the catch-up method.

 

 

 

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Cover
May 08, 2025
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date May 08, 2025
Entity File Number 001-39577
Entity Registrant Name ELUTIA INC.
Entity Central Index Key 0001708527
Entity Tax Identification Number 47-4790334
Entity Incorporation, State or Country Code DE
Entity Address, Address Line One 12510 Prosperity Drive
Entity Address, Address Line Two Suite 370,
Entity Address, City or Town Silver Spring
Entity Address, State or Province MD
Entity Address, Postal Zip Code 20904
City Area Code 240
Local Phone Number 247-1170
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Class A Common Stock, $0.001 par value per share
Trading Symbol ELUT
Security Exchange Name NASDAQ
Entity Emerging Growth Company true
Elected Not To Use the Extended Transition Period false
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