Elutia(ELUT)

Search documents
Elutia Appoints Accomplished MedTech Veteran Guido J. Neels to Board of Directors
Globenewswire· 2025-10-10 12:00
Industry leader brings 40 years of executive and board experience across the global medical technology sector GAITHERSBURG, Md., Oct. 10, 2025 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix technologies, announced the appointment of Guido J. Neels to the Company’s Board of Directors. Mr. Neels will also serve as a member of the audit committee of the Board. In conjunction with Mr. Neels’ appointment, W. Matthew Zuga and Maybelle Jordan have bo ...
Elutia Announces Closing of BioEnvelope Business Sale to Boston Scientific Corporation for $88 Million
Globenewswire· 2025-10-01 12:41
- Strengthened balance sheet to fully fund development and launch of NXT-41 platform - - Biologics for breast reconstruction represents $1.5 billion U.S. total addressable market - GAITHERSBURG, Md., Oct. 01, 2025 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix technologies, today announced the closing of the sale of its BioEnvelope business, including the EluPro™ and CanGaroo® bioenvelopes, to Boston Scientific Corporation (NYSE: BSX) for $88 ...
Elutia Announces Newly Published Clinical Data Demonstrating that Biologic Envelopes Support CIED Stabilization and Ease of Reoperation
Globenewswire· 2025-09-16 12:00
- Findings highlight the potential of antibiotic-eluting bioenvelopes to transform cardiac implantable electronic device (CIED) pocket management - GAITHERSBURG, Md., Sept. 16, 2025 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix technologies, today announced the publication of clinical and preclinical data supporting the clinical utility of a biologic envelope that secures cardiac implantable electronic devices (CIEDs), promotes tissue remodel ...
Down 25.9% in 4 Weeks, Here's Why ELUTIA INC (ELUT) Looks Ripe for a Turnaround
ZACKS· 2025-09-10 14:35
Elutia Inc. (ELUT) has been beaten down lately with too much selling pressure. While the stock has lost 25.9% over the past four weeks, there is light at the end of the tunnel as it is now in oversold territory and Wall Street analysts expect the company to report better earnings than they predicted earlier.We use Relative Strength Index (RSI), one of the most commonly used technical indicators, for spotting whether a stock is oversold. This is a momentum oscillator that measures the speed and change of pri ...
Elutia Announces Sale of BioEnvelope Business to Boston Scientific Corporation for $88 Million
Globenewswire· 2025-09-09 12:30
- Transaction affirms the strength of Elutia’s proprietary drug-eluting biologics platform and fully funds advancement of NXT-41 in breast reconstruction - - Company to provide update at the H.C. Wainwright 27th Annual Global Investment Conference on Wednesday, September 10 at 9:30 a.m. ET - GAITHERSBURG, Md., Sept. 09, 2025 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix technologies, today announced it has entered into a definitive agreement ...
Elutia (ELUT) 2025 Conference Transcript
2025-09-04 14:45
Elutia (ELUT) 2025 Conference September 04, 2025 09:45 AM ET Speaker0That's fine. I can. All right. Let's go ahead and get started.My name is Matthew Park. I'm part of the med tech and diagnostics equity research team here at Canner, and we're excited to be joined, by the management team from Aleutia today. So maybe to kick things off, would you mind briefly introducing yourselves before we jump into the discussion?Speaker1Sure. Randy Mills. I am, the CEO, and I'm also a cofounder, of Aleutia. Been in this ...
Elutia Selected to Exhibit EluPro™ Antibiotic Eluting BioEnvelope at Vizient Innovative Technology Exchange
Globenewswire· 2025-09-04 12:00
GAITHERSBURG, Md., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix technologies, today announced that it has been selected to exhibit the EluPro™ Antibiotic-Eluting BioEnvelope at the Vizient Innovative Technology Exchange (“Vizient”). Vizient®, the nation’s largest provider-driven healthcare performance improvement company, will hold the Innovative Technology Exchange on Wednesday, September 17, 2025 in Las Vegas. The annual Inn ...
All You Need to Know About ELUTIA INC (ELUT) Rating Upgrade to Buy
ZACKS· 2025-09-01 17:01
Core Viewpoint - Elutia Inc. (ELUT) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive outlook based on rising earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system emphasizes the importance of earnings estimate revisions, which are strongly correlated with near-term stock price movements [4][6]. - For Elutia Inc., the recent increase in earnings estimates suggests an improvement in the company's underlying business, likely leading to a higher stock price [5]. Zacks Rating System - The Zacks Rank stock-rating system categorizes stocks into five groups based on earnings estimates, with a proven track record of Zacks Rank 1 stocks generating an average annual return of +25% since 1988 [7]. - The system maintains a balanced distribution of "buy" and "sell" ratings, ensuring that only the top 20% of stocks receive a "Strong Buy" or "Buy" rating, indicating superior earnings estimate revisions [9][10]. Earnings Estimate Revisions for Elutia Inc. - Elutia Inc. is projected to earn -$0.52 per share for the fiscal year ending December 2025, with no year-over-year change [8]. - Over the past three months, the Zacks Consensus Estimate for Elutia Inc. has increased by 20%, reflecting analysts' growing confidence in the company's earnings potential [8].
Elutia(ELUT) - 2025 Q2 - Earnings Call Transcript
2025-08-14 22:00
Financial Data and Key Metrics Changes - The company reported a 33% year-over-year increase in bioenvelope revenue for the quarter, reaching a run rate of approximately $14 million [10] - Elupro revenue grew 49% sequentially, now accounting for 68% of total bioenvelope revenue [10][12] - Adjusted gross margin improved to 62.4%, up over four percentage points from the previous year [34] - The company ended Q2 with $8.5 million in cash, indicating a stable financial position [36] Business Line Data and Key Metrics Changes - Elupro's sales per account are 130% higher than the previous product, Kangaroo, reflecting greater utilization [13] - The cardiovascular patch products generated over $700,000 in revenue for a partial quarter, more than double the previous distributor's revenue [32] - SimpliDerm revenue decreased to $2 million, indicating potential for improvement in that product line [33] Market Data and Key Metrics Changes - The breast reconstruction market is valued at $1.5 billion in the U.S., with biologics accounting for 65% of device-related spending [20] - Approximately 317,000 women are diagnosed with invasive breast cancer annually, leading to significant market potential for reconstruction products [19] Company Strategy and Development Direction - The company aims to scale Elupro by increasing the number of VAC approvals and GPO coverage [38] - The NXT 41 platform is positioned to address significant unmet medical needs in breast reconstruction, with anticipated market launch in 2026 [25][40] - The company is exploring strategic opportunities that may positively impact cash position in the near future [36][41] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of Elupro, citing predictable ordering patterns and strong hospital partnerships [46][50] - The company is focused on addressing the high complication rates in breast reconstruction procedures, emphasizing the need for innovative solutions [22][23] Other Important Information - The company has settled 97 out of 110 lawsuits related to a past product recall, significantly reducing future expenses and legal overhang [29][30] - The company is actively working on business development transactions, with expectations for announcements in the near future [41] Q&A Session Summary Question: What are the bottlenecks in the Elupro launch? - Management noted initial production challenges but emphasized that operations have now stabilized, allowing for efficient scaling [45][46] Question: Can you clarify the NXT 41 launch timeline? - The base matrix is expected to launch in 2026, followed by the drug-eluting version in 2027, with a focus on regulatory strategy [52][56] Question: How can gross margins be maintained or expanded? - Management highlighted opportunities for margin improvement across all business segments, particularly in Elupro and cardiovascular products [64] Question: What level of clinical evidence is needed for NXT 41? - The company plans to follow a similar regulatory pathway as Elupro, focusing on generating clinical data for marketing purposes [67]
Elutia(ELUT) - 2025 Q2 - Quarterly Report
2025-08-14 21:00
PART I – FINANCIAL INFORMATION [Item 1. Financial Statements](index=8&type=section&id=Item%201.%20Financial%20Statements) The unaudited financial statements show a net loss of $13.5 million for H1 2025 and a significant 'going concern' uncertainty [Condensed Consolidated Balance Sheets](index=8&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of June 30, 2025, shows total assets of $33.8 million and a stockholders' deficit of $41.8 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $8,500 | $13,239 | | Total current assets | $22,280 | $26,172 | | Total assets | $33,849 | $36,127 | | Total current liabilities | $37,948 | $37,795 | | Total liabilities | $75,692 | $82,387 | | Total stockholders' deficit | $(41,843) | $(46,260) | [Condensed Consolidated Statements of Operations](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a net loss of $13.5 million for H1 2025, an improvement from $46.2 million in H1 2024 due to warrant liability revaluation Q2 Statement of Operations Highlights (in thousands) | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Net sales | $6,263 | $6,291 | | Gross profit | $3,058 | $2,799 | | Loss from operations | $(9,875) | $(8,510) | | (Gain) loss on revaluation of warrant liability | $(2,233) | $18,337 | | Net loss from continuing operations | $(9,610) | $(28,360) | Six-Month Statement of Operations Highlights (in thousands) | Metric | H1 2025 | H1 2024 | | :--- | :--- | :--- | | Net sales | $12,293 | $12,985 | | Gross profit | $5,515 | $5,642 | | Loss from operations | $(17,797) | $(16,989) | | (Gain) loss on revaluation of warrant liability | $(7,420) | $27,974 | | Net loss from continuing operations | $(13,543) | $(46,354) | [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash used in operations increased to $17.1 million in H1 2025, leading to a net decrease in cash of $4.7 million Six-Month Cash Flow Summary (in thousands) | Cash Flow Activity | H1 2025 | H1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(17,109) | $(6,973) | | Net cash provided by (used in) investing activities | $(392) | $167 | | Net cash provided by financing activities | $12,762 | $5,718 | | **Net decrease in cash and cash equivalents** | **$(4,739)** | **$(1,088)** | [Notes to Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes disclose substantial 'going concern' doubt, a $17.0 million contingent liability for product recalls, and debt amendments - The company has substantial doubt about its ability to continue as a going concern due to a **net loss of $13.5 million** and **$17.1 million of cash used in operations** for the six months ended June 30, 2025, along with an accumulated deficit of $243.1 million[43](index=43&type=chunk) - The company has accrued a **contingent liability of $17.0 million** for legal proceedings as of June 30, 2025, related to the FiberCel and VBM product recalls[27](index=27&type=chunk)[127](index=127&type=chunk)[129](index=129&type=chunk) - In May 2025, the company amended its SWK Loan Facility to, among other things, fix the minimum liquidity covenant at **$8.0 million** and allow the May 2025 interest payment to be paid-in-kind (PIK)[99](index=99&type=chunk) Net Sales by Segment - Q2 2025 (in thousands) | Segment | Net Sales | | :--- | :--- | | Device Protection | $3,516 | | Women's Health | $2,011 | | Cardiovascular | $736 | | **Total** | **$6,263** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=47&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the EluPro launch driving Device Protection sales, offset by declines in other segments and ongoing liquidity challenges [Overview](index=47&type=section&id=Overview) The company focuses on Device Protection and Women's Health markets, with success highly dependent on the new EluPro product - The company's mission is to reduce complications associated with implanted medical devices, focusing on Device Protection and Women's Health markets[148](index=148&type=chunk)[150](index=150&type=chunk) - The company's success is highly dependent on the successful commercialization, marketing, and sale of its **EluPro product**, which was cleared by the FDA in June 2024[159](index=159&type=chunk) - The company divested its Orthobiologics Business in November 2023 but retained liabilities from the **FiberCel and VBM product recalls**, which are subject to ongoing litigation[160](index=160&type=chunk)[162](index=162&type=chunk)[163](index=163&type=chunk) [Results of Operations](index=54&type=section&id=Results%20of%20Operations) Q2 2025 net sales were flat as Device Protection growth was offset by declines elsewhere, while litigation costs rose significantly Net Sales by Segment: Q2 2025 vs Q2 2024 (in thousands) | Segment | Q2 2025 | Q2 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Device Protection | $3,516 | $2,639 | $877 | 33.2% | | Women's Health | $2,011 | $2,571 | $(560) | (21.8)% | | Cardiovascular | $736 | $1,081 | $(345) | (31.9)% | | **Total Net Sales** | **$6,263** | **$6,291** | **$(28)** | **(0.4)%** | - Gross margin, excluding intangible asset amortization, **improved to 62.4%** in Q2 2025 from 58.0% in Q2 2024, primarily due to production efficiencies in the Device Protection segment[177](index=177&type=chunk) - Litigation costs **increased to $4.0 million** in Q2 2025 from $2.3 million in Q2 2024, as the company has no more insurance to cover the cost of the FiberCel Litigation[182](index=182&type=chunk) [Liquidity and Capital Resources](index=63&type=section&id=Liquidity%20and%20Capital%20Resources) The company faces significant liquidity concerns with only $8.5 million in cash and substantial doubt about its 'going concern' status - As of June 30, 2025, the company had **cash of $8.5 million** and an **accumulated deficit of $243.1 million**[199](index=199&type=chunk) - The company raised gross proceeds of approximately **$15.0 million** in a registered direct offering in February 2025 and **$13.3 million** in June 2024 to fund operations[200](index=200&type=chunk)[201](index=201&type=chunk) - Management has **substantial doubt** about the company's ability to continue as a going concern due to expected continued losses and uncertainty about its ability to raise sufficient capital[205](index=205&type=chunk)[227](index=227&type=chunk) - The company has **$24.3 million of indebtedness outstanding** as of June 30, 2025, primarily under its SWK Loan Facility, with principal payments scheduled to begin in November 2025[212](index=212&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=75&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risks are interest rate fluctuations on its variable-rate debt and credit risk from cash deposits - The company's main market risk is **interest rate risk** from its variable-rate SWK Loan Facility[235](index=235&type=chunk) - **Credit risk** exists as cash balances are maintained at two financial institutions and may exceed federally insured limits[236](index=236&type=chunk) [Item 4. Controls and Procedures](index=77&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of the end of the reporting period - Management concluded that **disclosure controls and procedures were effective** as of June 30, 2025[241](index=241&type=chunk) - **No material changes** to internal control over financial reporting occurred during the six months ended June 30, 2025[242](index=242&type=chunk) PART II – OTHER INFORMATION [Item 1. Legal Proceedings](index=77&type=section&id=Item%201.%20Legal%20Proceedings) This section refers to Note 9 of the financial statements for details on legal proceedings related to product recalls - For information about legal proceedings, the report refers to **Note 9** of the condensed consolidated financial statements[244](index=244&type=chunk) [Item 1A. Risk Factors](index=77&type=section&id=Item%201A.%20Risk%20Factors) No material changes to the company's previously disclosed risk factors were reported during the period - There have been **no material changes** in risk factors from those included in the company's Annual Report[245](index=245&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=77&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company did not conduct any unregistered sales of equity securities during the reporting period - None[246](index=246&type=chunk) [Item 5. Other Information](index=79&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 trading plans during the six-month period - No directors or officers adopted or terminated any **Rule 10b5-1 trading plans** during the six-month period[250](index=250&type=chunk) [Item 6. Exhibits](index=79&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the report, including credit agreement amendments and officer certifications - Lists various agreements and certifications filed as exhibits, such as amendments to the Royalty Agreement with Ligand and the Credit Agreement with SWK Funding[251](index=251&type=chunk)[252](index=252&type=chunk)[253](index=253&type=chunk)