EluPro Commercial Progress - EluPro实现了显著的商业成功，同比增长49%[12] - EluPro的增长现在占BioEnvelope收入的68%[14] - 已经获得了7个国家GPO合同[12, 21, 22] - 161家医院积极订购EluPro[12, 23] - 预计年底销售额将接近2000万美元[17] - 通过波士顿科学公司销售的EluPro案例占30%[18] Reconstruction Pipeline - 生物制剂代表着15亿美元的美国市场，占重建支出的65%[28] - 每年大约有151,000例乳房切除术，其中三分之二是双侧乳房切除术，导致200,000-225,000个乳房重建[30] - 生物网在80%的重建案例中使用，每个乳房的成本为7,500-9,500美元[30] - 1/3的患者在乳房重建后会出现严重的并发症[31] Litigation Update - 在FiberCel诉讼方面取得了重大进展，自2025年第一季度以来已解决了27起案件[42] - 总共解决了110起案件中的97起[42] Financial Review - BioEnvelope（EluPro和CanGaroo）的净销售额为350万美元，而去年同期为260万美元[45] - 调整后的毛利率为62.4%，而去年同期为58.0%[45] - 截至2025年6月30日，现金余额为850万美元[45]

[Business Update and Highlights](index=1&type=section&id=Business%20Update%20and%20Highlights) Elutia reported robust Q2 2025 growth, driven by strong EluPro™ adoption and expanded hospital access, while advancing its NXT-41 platform and resolving FiberCel litigation [EluPro™ Performance and Market Adoption](index=1&type=section&id=EluPro%E2%84%A2%20Performance%20and%20Market%20Adoption) EluPro™ demonstrated strong Q2 2025 commercial momentum with 49% sequential revenue growth, rapid market penetration, and higher average sales per customer | Metric | Q2 2025 Performance | | :--- | :--- | | **EluPro™ Revenue Growth** | Up 49% sequentially | | **Total BioEnvelope Revenue** | $3.5 million (Up 33% YoY) | | **EluPro™ Sales Contribution** | ~66% of total BioEnvelope sales | - Market access for EluPro™ has expanded significantly, achieving Value Analysis Committee (VAC) approvals in over 160 centers, with the customer base growing more than **15 times** since launch[4](index=4&type=chunk)[5](index=5&type=chunk) - EluPro demonstrates strong clinical demand, with average sales per customer being **130% higher** than the legacy CanGaroo product, indicating deeper procedure penetration[5](index=5&type=chunk) - The company utilizes an efficient selling model with both direct and distributor channels, with distributor-led growth now accounting for approximately **33% of EluPro sales**[5](index=5&type=chunk) [Pipeline and Portfolio Update](index=1&type=section&id=Pipeline%20and%20Portfolio%20Update) Elutia is advancing its NXT-41x platform for breast reconstruction, targeting FDA clearance in 2026-2027, and regained direct control of its Cardiovascular portfolio, generating $736K in Q2 2025 - The company is progressing its NXT-41x platform for breast reconstruction, targeting a **$1.5 billion market** with high complication rates[4](index=4&type=chunk)[5](index=5&type=chunk) | Pipeline Product | Target Indication | FDA Clearance Timeline | | :--- | :--- | :--- | | **NXT-41x (Base Matrix)** | Breast Reconstruction | 2H 2026 | | **NXT-41x (Drug-eluting)** | Breast Reconstruction | 1H 2027 | - Elutia regained direct sales control of its Cardiovascular portfolio in May 2025, generating **$736K in revenue** in its first partial quarter[5](index=5&type=chunk) [Corporate and Legal Updates](index=1&type=section&id=Corporate%20and%20Legal%20Updates) The company has substantially resolved its legacy FiberCel litigation, settling 97 out of 110 cases, which is expected to significantly reduce future legal expenses - Elutia has settled an additional **27 FiberCel cases**, bringing the total number of settlements to **97 out of 110**, which is expected to significantly lower future litigation expenses[5](index=5&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) Elutia's Q2 2025 net sales remained stable at $6.3 million, with a significantly improved net loss of $9.6 million, though adjusted EBITDA loss widened to $3.8 million | Financial Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | Change | | :--- | :--- | :--- | :--- | | **Overall Net Sales** | $6.3M | $6.3M | ~0% | | **GAAP Gross Margin** | 48.8% | 44.5% | +4.3 p.p. | | **Adjusted Gross Margin** | 62.4% | 58.0% | +4.4 p.p. | | **Loss from Operations** | ($9.9M) | ($8.5M) | +16.5% | | **Net Loss** | ($9.6M) | ($28.2M) | -66% | | **Adjusted EBITDA** | ($3.8M) | ($2.6M) | +45.3% | | **Cash Balance (as of 6/30)** | $8.5M | N/A | N/A | | Net Sales by Product | Q2 2025 (in millions) | Q2 2024 (in millions) | Change (YoY) | | :--- | :--- | :--- | :--- | | **BioEnvelope** | $3.5M | $2.6M | +33% | | **SimpliDerm** | $2.0M | $2.6M | -23% | | **Cardiovascular** | $0.7M | $1.1M | -36% | [Financial Statements](index=5&type=section&id=Financial%20Statements) This section presents Elutia's unaudited consolidated financial statements as of June 30, 2025, including the Balance Sheet and Statement of Operations [Consolidated Balance Sheet](index=5&type=section&id=Consolidated%20Balance%20Sheet) As of June 30, 2025, Elutia reported $8.5 million in cash, $33.8 million in total assets, $75.7 million in total liabilities, and a $41.8 million stockholders' deficit | Balance Sheet Item (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Cash** | $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) | [Consolidated Statement of Operations](index=6&type=section&id=Consolidated%20Statement%20of%20Operations) For Q2 2025, Elutia reported $6.3 million net sales, $3.1 million gross profit, a $9.9 million operating loss, and a $9.6 million net loss, or ($0.23) per share | Statement of Operations (in thousands) | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | **Net sales** | $6,263 | $6,291 | | **Gross profit** | $3,058 | $2,799 | | **Total operating expenses** | $12,933 | $11,309 | | **Loss from operations** | ($9,875) | ($8,510) | | **Net loss** | ($9,610) | ($28,180) | | **Net loss per share - basic** | ($0.23) | ($1.13) | [Non-GAAP Financial Measures](index=3&type=section&id=Non-GAAP%20Financial%20Measures) Elutia provides non-GAAP measures like adjusted gross margin and EBITDA to supplement GAAP results, excluding non-cash items and litigation costs for core performance evaluation - The company presents non-GAAP financial measures such as adjusted EBITDA and adjusted gross margin to provide supplemental information to investors, excluding items like stock-based compensation, litigation costs, and amortization of acquired intangible assets[9](index=9&type=chunk) [Non-GAAP Gross Profit and Gross Margin Reconciliation](index=7&type=section&id=Non-GAAP%20Gross%20Profit%20and%20Gross%20Margin%20Reconciliation) In Q2 2025, Elutia's adjusted gross profit was $3.9 million, with an adjusted gross margin of 62.4%, reflecting an improvement from the prior year | Gross Profit/Margin (in thousands) | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | **Gross profit (GAAP)** | $3,058 | $2,799 | | **Adjusted gross profit (Non-GAAP)** | $3,907 | $3,648 | | **Gross margin (GAAP)** | 48.8% | 44.5% | | **Adjusted gross margin (Non-GAAP)** | 62.4% | 58.0% | [EBITDA and Adjusted EBITDA Reconciliation](index=7&type=section&id=EBITDA%20and%20Adjusted%20EBITDA%20Reconciliation) Elutia's Q2 2025 adjusted EBITDA was a loss of $3.8 million, calculated by adjusting net loss for non-cash gains and litigation costs | EBITDA Reconciliation (in thousands) | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | **Net loss** | ($9,610) | ($28,180) | | **EBITDA (Non-GAAP)** | ($8,191) | ($26,062) | | **Adjusted EBITDA (Non-GAAP)** | ($3,829) | ($2,648) |

Core Insights - Elutia Inc. reported a significant revenue increase for its EluPro product, with a 49% sequential growth in Q2 2025 and a 33% year-over-year increase in total BioEnvelope sales, reaching $3.5 million [2][5][6] - The company is advancing its next-generation drug-eluting biomatrix, NXT-41, targeting a $1.5 billion market for breast reconstruction, with initial product launch planned for the second half of 2026 [2][4] Business Highlights - EluPro has become the preferred choice in cardiac implantable electronic device procedures, expanding into over 160 VAC-approved hospitals and growing its customer base more than 15 times since launch [4][6] - The average sales per EluPro customer were 130% higher than those for the legacy CanGaroo platform, indicating stronger market penetration [6] - Elutia has received two awards for innovation and product launches, and has published five peer-reviewed articles on EluPro, showcasing its scientific leadership [6] Financial Performance - For Q2 2025, Elutia's overall net sales were $6.3 million, nearly unchanged from Q2 2024, with a gross margin of 48.8%, up from 44.5% [9][15] - The company reported a net loss of $9.6 million for Q2 2025, a significant improvement compared to a net loss of $28.2 million in the same period of the previous year [9][15] - Adjusted EBITDA for Q2 2025 was a loss of $3.8 million, compared to a loss of $2.6 million in Q2 2024 [9][18] Market Access and Growth Strategy - Elutia's distribution strategy includes a partnership with Boston Scientific and a focus on expanding access through national GPO contracts and VAC approvals [2][4] - The company regained direct control of its cardiovascular product sales, generating $736K in revenue in the first partial quarter of direct sales [6] Litigation and Financial Position - Elutia has resolved 97 out of 110 cases related to FiberCel litigation, significantly reducing expected litigation expenses [6] - As of June 30, 2025, the company had a cash balance of $8.5 million, down from $13.2 million a year earlier [9][13]

Group 1 - Elutia Inc. will release its second quarter 2025 financial results after market close on August 14, 2025 [1] - A conference call and webcast will be hosted by the management team at 5:00 p.m. Eastern Time on the same day [1] - The conference call can be accessed by U.S. investors at 877-407-8029 and international investors at 201-689-8029, with a Conference ID of 13754773 [1] Group 2 - Elutia develops drug-eluting biomatrix products aimed at improving compatibility between medical devices and patients [2] - The company focuses on addressing the needs of a growing population requiring implantable technologies [2] - Elutia's mission is to humanize medicine, allowing patients to thrive without compromise [2]

Core Insights - Elutia Inc. has announced that Dr. Michelle LeRoux Williams, the Chief Scientific Officer, received the Medical Device Innovator Award for her contributions to the medical device industry, particularly for the development of EluPro™ [1][2] - EluPro™ is recognized as the world's first FDA-cleared antibiotic-eluting bioenvelope for cardiac implantable electronic devices (CIEDs), addressing significant complications associated with these devices [1][2][3] Company Overview - Elutia specializes in developing and commercializing drug-eluting biomatrix products aimed at improving compatibility between medical devices and patients [4] - The company focuses on humanizing medicine to enhance patient outcomes, particularly for those requiring implantable technologies [4] Product Details - EluPro™ combines a soft, regenerative biomatrix with antibiotics rifampin and minocycline to mitigate complications such as infection, migration, and skin erosion, which occur in 5-7% of the over 600,000 CIEDs implanted annually in the U.S. [3] - The product has received FDA clearance for use across all major CIED products, including pacemakers and implantable defibrillators, as well as neurostimulation devices [2][3]

Core Insights - Elutia Inc. has published a study demonstrating the bioactive properties of its EluPro BioEnvelope, which shows superior healing responses compared to synthetic materials for cardiac implantable electronic devices (CIEDs) [1][4] - The study indicates that EluPro controls inflammation and supports vascularization, which are crucial for reducing scarring and infection risks associated with CIED implantation [1][2] Group 1: Study Findings - The preclinical study revealed that EluPro stimulates early proangiogenic signals and reduces fibrosis over time, addressing precursors to pocket infection [2] - Mechanistic studies showed that fibroblasts in the biomatrix environment released significantly higher levels of growth and wound healing factors compared to controls (p<0.001) [3] - Long-term animal studies indicated that the biomatrix promoted blood vessel formation (angiogenesis) and reduced inflammation and scarring over a 26-week period, while synthetic materials exhibited persistent inflammation and fibrosis [3] Group 2: Product and Market Position - EluPro is the first and only FDA-cleared antibiotic-eluting bioenvelope designed for use with CIEDs and neurostimulators, launched commercially in the U.S. in January 2025 [4] - The company aims to expand its proprietary drug-eluting biomaterial platform to address other high-impact medical indications, focusing on improving patient outcomes through biologic solutions [4][6] Group 3: Company Overview - Elutia develops and commercializes drug-eluting biomatrix products to enhance compatibility between medical devices and patients, with a mission to humanize medicine [6]

Core Insights - Elutia Inc. has been recognized with two awards in the 2025 Medical Device Network Excellence Awards for its innovations in drug-eluting biomatrix technologies and the successful launch of EluPro [3][4] - EluPro has shown strong commercial performance since its pilot launch in September 2024, with a sequential sales increase of 84% in Q1 2025 and a year-over-year revenue increase of 31% in BioEnvelope sales [4][6] - The product is cleared for use with all major cardiac implantable electronic devices (CIEDs) and neurostimulation devices, addressing complications such as infection and migration [5][6] Company Performance - EluPro was commercially launched in January 2025 and has received approvals from 150 hospital value analysis committees, indicating strong clinical demand [4][6] - The product has established partnerships with seven major group purchasing organizations, reflecting its acceptance within the healthcare procurement ecosystem [4] Product Details - EluPro combines a soft, regenerative biomatrix with antibiotics rifampin and minocycline to enhance healing and reduce complications associated with CIEDs [5][6] - With over 600,000 CIEDs implanted annually in the U.S. and complications occurring in 5-7% of cases, EluPro aims to improve patient outcomes significantly [6] Industry Recognition - The Medical Device Network Excellence Awards analyze over 1 billion datasets annually to recognize top-tier companies in the medical device industry [8] - The awards honor innovative companies that drive positive change, highlighting Elutia's commitment to advancing medical technology [8]

Core Insights - Elutia Inc. has developed a validated method for measuring antibiotic release from a biologic envelope, which accelerates product development and testing [1][2] - The new method provides reliable data in 30 hours, significantly faster than the traditional 14-day in vivo protocols, enhancing efficiency in drug release testing [2][3] - EluPro, the first FDA-cleared antibiotic-eluting bioenvelope, was launched in January 2025 and is designed for use with cardiac implantable electronic devices and neurostimulators [3] Company Overview - Elutia focuses on drug-eluting biomatrix products to improve compatibility between medical devices and patients, aiming to humanize medicine for those needing implantable technologies [5] - The company emphasizes the importance of drug elution performance for manufacturing consistency and regulatory evaluation, as recognized by the FDA [2][3] - Elutia's innovative approach supports the product lifecycle of EluPro and future drug-eluting biologic matrices, showcasing its leadership in the field [3]

```markdown [FORWARD-LOOKING STATEMENTS](index=2&type=section&id=FORWARD-LOOKING%20STATEMENTS) This section outlines forward-looking statements and key risks concerning operations, product commercialization, and ongoing litigation - The report contains forward-looking statements regarding **results of operations**, **financial position**, **business strategy**, **product expectations**, **sales and marketing growth**, **earnout payments from the Orthobiologics segment sale**, **product development**, **expenses**, **seasonality**, **competitive advantages**, and **ongoing litigation** (FiberCel, VBM, Medtronic)[7](index=7&type=chunk) - Key risks include the ability to successfully commercialize **EluPro**, continue as a **going concern**, achieve **profitability**, manage **product liability claims**, raise **future funds**, ensure **product acceptance**, enhance **product offerings**, and manage dependence on **commercial partners and suppliers**[9](index=9&type=chunk)[10](index=10&type=chunk)[17](index=17&type=chunk) [WEBSITE DISCLOSURE](index=4&type=section&id=WEBSITE%20DISCLOSURE) Elutia Inc. utilizes its Investor Relations website as a primary channel for material financial and company information - Elutia Inc. uses its Investor Relations section on **www.Elutia.com** as a distribution channel for material financial and other important company information, offering email alerts for updates[16](index=16&type=chunk) [TRADEMARKS, TRADE NAMES AND SERVICE MARKS](index=6&type=section&id=TRADEMARKS%2C%20TRADE%20NAMES%20AND%20SERVICE%20MARKS) This section lists proprietary trademarks and service marks protected under intellectual property laws - The report includes proprietary trademarks such as **Elutia®**, **CanGaroo®**, **EluPro®**, **CanGarooRM®**, **ProxiCor®**, **Tyke®**, **VasCure®**, **SimpliDerm®**, and **SimpliDerm Ellipse®**, which are protected under intellectual property laws[19](index=19&type=chunk) [INDUSTRY AND OTHER DATA](index=6&type=section&id=INDUSTRY%20AND%20OTHER%20DATA) Industry and market data in the report are based on management estimates and third-party publications, subject to inherent risks - Industry and market information in the report is based on management's estimates, internal research, and third-party publications, which are believed to be reliable but involve assumptions and limitations subject to various risks[21](index=21&type=chunk) [PART I – FINANCIAL INFORMATION](index=8&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) This section presents Elutia Inc.'s unaudited condensed consolidated financial statements and management's analysis for the quarter [Item 1. Financial Statements (Unaudited)](index=8&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents Elutia Inc.'s unaudited condensed consolidated financial statements for the three months ended March 31, 2025, including balance sheets, statements of operations, changes in stockholders' equity, and cash flows, along with detailed notes on accounting policies, debt, equity, and contingencies. The company reported a net loss of $3.9 million for the quarter and faces substantial doubt about its ability to continue as a going concern due to accumulated deficits and cash outflows [Condensed Consolidated Balance Sheets](index=8&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Balance Sheet Data | Metric | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :----------------------------- | :----------------------------- | | Cash and cash equivalents | $17,358 | $13,239 | | Total current assets | $30,017 | $26,172 | | Total assets | $39,298 | $36,127 | | Total current liabilities | $36,851 | $37,795 | | Total liabilities | $75,756 | $82,387 | | Total stockholders' deficit | $(36,458) | $(46,260) | [Condensed Consolidated Statements of Operations](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Statements of Operations Data | Metric | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | :-------------------------------- | :----------------------------------- | :----------------------------------- | | Net sales | $6,030 | $6,694 | | Gross profit | $2,457 | $2,843 | | Total operating expenses | $10,379 | $11,322 | | Loss from operations | $(7,922) | $(8,479) | | (Gain) loss on revaluation of warrant liability | $(5,187) | $9,637 | | Net loss | $(3,933) | $(17,994) | | Net loss per share - basic | $(0.10) | $(0.75) | | Net loss per share - diluted | $(0.21) | $(0.75) | [Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit)](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity%20(Deficit)) Stockholders' Equity Data | Metric | December 31, 2024 (in thousands) | March 31, 2025 (in thousands) | | :-------------------------------- | :----------------------------- | :----------------------------- | | Total stockholders' deficit | $(46,260) | $(36,458) | | Issuance of common stock (net) | $12,596 | N/A | | Stock-based compensation | $1,211 | N/A | | Net loss | $(3,933) | N/A | - The company issued **5,520,000 shares** of Class A common stock in a registered direct offering, net of **$1.2 million** issuance costs, contributing **$12.6 million** to equity[32](index=32&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Data | Metric | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | :-------------------------------- | :----------------------------------- | :----------------------------------- | | Net cash used in operating activities | $(8,881) | $(2,641) | | Net cash used in investing activities | $(278) | $(15) | | Net cash provided by (used in) financing activities | $13,278 | $(4,069) | | Net increase (decrease) in cash and cash equivalents | $4,119 | $(6,725) | | Cash and cash equivalents, end of period | $17,358 | $12,551 | - Financing activities provided **$13.3 million** in cash for Q1 2025, primarily from a private placement and warrants, offsetting cash used in operations[35](index=35&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed notes on Elutia Inc.'s accounting policies, debt, equity, and contingencies [Note 1. Organization and Description of Business](index=12&type=section&id=Note%201.%20Organization%20and%20Description%20of%20Business) - Elutia Inc. is a commercial-stage company focused on improving medical device-patient interaction through biologics and local drug delivery, with products in **Device Protection**, **Women's Health**, and **Cardiovascular** markets[38](index=38&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=12&type=section&id=Note%202.%20Summary%20of%20Significant%20Accounting%20Policies) - The unaudited condensed consolidated financial statements are prepared in accordance with GAAP for interim information, and the company has evaluated its ability to continue as a **going concern**, noting substantial doubt due to a net loss of **$3.9 million** and an accumulated deficit of **$233.5 million** as of March 31, 2025[39](index=39&type=chunk)[44](index=44&type=chunk) - The company completed the sale of its Orthobiologics Business in November 2023 for approximately **$14.6 million**, with potential earn-out payments up to an additional **$20 million**, while retaining liabilities for FiberCel and VBM litigation[41](index=41&type=chunk) - Revenue is recognized when performance obligations are met and control of products transfers to customers, either upon shipment or delivery/use for consigned inventory[69](index=69&type=chunk)[70](index=70&type=chunk)[71](index=71&type=chunk) - One customer accounted for **15%** of net sales and **15%** of accounts receivable as of March 31, 2025[79](index=79&type=chunk) [Note 3. Recently Issued Accounting Standards](index=22&type=section&id=Note%203.%20Recently%20Issued%20Accounting%20Standards) - ASU 2023-09 (Income Tax Disclosures) is effective for fiscal years beginning after **December 15, 2024**, and is not expected to have a material effect on financial condition, results of operations, or cash flows[83](index=83&type=chunk) - ASU 2024-03 (Expense Disaggregation Disclosures) is effective for annual reporting periods beginning after **December 15, 2026**, and the company is currently evaluating its disclosure requirements[84](index=84&type=chunk)[85](index=85&type=chunk)[86](index=86&type=chunk) [Note 4. Stock-Based Compensation](index=24&type=section&id=Note%204.%20Stock-Based%20Compensation) Stock-Based Compensation Data | Metric | March 31, 2025 | December 31, 2024 | | :-------------------------------- | :------------- | :---------------- | | Stock Options Outstanding | 3,204,215 | 3,220,991 | | RSUs Unvested | 1,342,766 | 1,417,123 | | Total Stock-Based Compensation Expense (Q1 2025) | $1,211 (in thousands) | N/A | | Total Stock-Based Compensation Expense (Q1 2024) | N/A | $2,197 (in thousands) | - Unrecognized compensation expense for unvested stock options was approximately **$2.7 million**, expected to be recognized over **1.7 years**, and for RSUs was **$3.9 million**, expected over **1.8 years**[88](index=88&type=chunk)[93](index=93&type=chunk) [Note 5. Inventory](index=28&type=section&id=Note%205.%20Inventory) Inventory Breakdown | Inventory Component | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :------------------ | :----------------------------- | :----------------------------- | | Raw materials | $329 | $440 | | Work in process | $1,060 | $740 | | Finished goods | $2,897 | $2,731 | | Total | $4,286 | $3,911 | [Note 6. Long-Term Debt](index=28&type=section&id=Note%206.%20Long-Term%20Debt) - The company has a **$25 million** SWK Loan Facility maturing in **August 2027**, with principal amortization starting in **November 2025**, bearing interest at SOFR plus an applicable margin (**7.75%** or **3.75%** with PIK option)[99](index=99&type=chunk)[100](index=100&type=chunk) - A **May 2025** amendment to the SWK Loan Facility allowed **100% PIK interest** for **May 2025**, removed mandatory prepayments from non-ordinary course asset sales, and fixed the minimum liquidity covenant at **$8.0 million**[101](index=101&type=chunk)[102](index=102&type=chunk) Long-Term Debt Summary | Debt Component | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :------------------------------------------------ | :----------------------------- | :----------------------------- | | Term Loan Facility, net | $24,262 | $23,853 | | Current Portion | $(2,500) | $(1,250) | | Long-Term Debt | $21,762 | $22,603 | [Note 7. Revenue Interest Obligation](index=30&type=section&id=Note%207.%20Revenue%20Interest%20Obligation) - The company has a Revenue Interest Obligation to Ligand Pharmaceuticals, amended in January 2024, requiring **5%** of future sales of certain products (CanGaroo, ProxiCor, Tyke, VasCure, EluPro) through **May 2027**, subject to annual minimum payments of **$4.4 million**[106](index=106&type=chunk) - In **May 2025**, **$2.2 million** in outstanding royalty obligations to Ligand was satisfied by issuing **1,105,528 shares** of Class A common stock[108](index=108&type=chunk) - A **$1.4 million** gain on revaluation of the Revenue Interest Obligation was recognized in Q1 2024 due to changes in estimated future payments[109](index=109&type=chunk) [Note 8. Common Stock and Warrants](index=32&type=section&id=Note%208.%20Common%20Stock%20and%20Warrants) Equity and Warrant Data | Offering | Date | Gross Proceeds (approx.) | Shares of Class A Common Stock | Prefunded Warrants | | :-------------------- | :----------- | :----------------------- | :----------------------------- | :------------------- | | 2025 Registered Offering | Feb 4, 2025 | $15.0 million | 5,520,000 | 480,000 | | 2024 Registered Offering | June 16, 2024 | $13.3 million | 3,175,000 | 725,000 | | 2023 Private Offering | Sep 21, 2023 | $10.5 million | 6,852,811 (Common Units) | 503,058 (Prefunded Units) | - All Common Warrants from the 2023 Private Offering were exercised by **July 31, 2024**, generating **$13.8 million** in exercise proceeds[117](index=117&type=chunk) Warrant Data | Warrant Type | Warrant Liability, Dec 31, 2024 (in thousands) | Fair Value Upon Issuance (Q1 2025) (in thousands) | Gain on Revaluation (Q1 2025) (in thousands) | Warrant Liability, Mar 31, 2025 (in thousands) | | :-------------------- | :----------------------------------- | :------------------------------------------ | :----------------------------------------- | :----------------------------------- | | 2023 Prefunded Warrants | $13,365 | - | $(4,324) | $9,041 | | 2024 Prefunded Warrants | $2,711 | - | $(877) | $1,834 | | 2025 Prefunded Warrants | - | $1,200 | $14 | $1,214 | | Total | $16,076 | $1,200 | $(5,187) | $12,089 | [Note 9. Commitments and Contingencies](index=36&type=section&id=Note%209.%20Commitments%20and%20Contingencies) - The company has a license and supply agreement with Cook Biotech for porcine tissue, with annual license fees of **$0.1 million** through **2026**[120](index=120&type=chunk) - FiberCel Litigation: **58 active lawsuits** as of March 31, 2025, with **$17.5 million** settled for **52 cases** and an estimated **$14.3 million** liability for the remaining cases. No more insurance coverage is available for FiberCel litigation costs[122](index=122&type=chunk)[126](index=126&type=chunk)[133](index=133&type=chunk) - VBM Litigation: **12 active lawsuits** as of March 31, 2025, with **$1.5 million** settled for **12 cases** and an estimated **$3.6 million** liability for the remaining **23 cases** (including unasserted claims). Insurance coverage remains available for VBM litigation costs[124](index=124&type=chunk)[129](index=129&type=chunk)[133](index=133&type=chunk) - Medtronic Litigation: Elutia sued Medtronic for breach of a supply agreement related to FiberCel. The court dismissed the insurance coverage claim but allowed the indemnity obligation claim to proceed[125](index=125&type=chunk) - Insurance Receivables of Litigation Costs totaled **$3.9 million** as of March 31, 2025, all related to the VBM Litigation[132](index=132&type=chunk)[133](index=133&type=chunk) [Note 10. Net Income (Loss) Per Share](index=41&type=section&id=Note%2010.%20Net%20Income%20(Loss)%20Per%20Share) Net Loss Per Share Data | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :----------------------------------- | :-------------------------------- | :-------------------------------- | | Net loss | $(3,933) (in thousands) | $(17,994) (in thousands) | | Net loss for diluted earnings per share | $(9,134) (in thousands) | $(17,994) (in thousands) | | Weighted average common shares outstanding - basic | 38,616,207 | 23,912,326 | | Weighted average common shares outstanding - diluted | 42,913,111 | 23,912,326 | | Net loss per share - basic | $(0.10) | $(0.75) | | Net loss per share - diluted | $(0.21) | $(0.75) | - Potential dilutive securities, including stock options, restricted stock units, and warrants, were excluded from diluted net loss per share calculation as their effect would be anti-dilutive[135](index=135&type=chunk) [Note 11. Segment Information](index=41&type=section&id=Note%2011.%20Segment%20Information) - Elutia operates in three segments: **Device Protection**, **Women's Health**, and **Cardiovascular**, with performance evaluated by the CEO based on segment net sales and gross profit (excluding intangible asset amortization)[136](index=136&type=chunk)[137](index=137&type=chunk) Segment Performance Data | Segment | Net Sales (Q1 2025, in thousands) | Segment Gross Profit (Q1 2025, in thousands) | | :---------------- | :------------------------------ | :------------------------------------------- | | Device Protection | $3,079 | $1,655 | | Women's Health | $2,625 | $1,452 | | Cardiovascular | $326 | $199 | | Total | $6,030 | $3,306 | Segment Performance Data | Segment | Net Sales (Q1 2024, in thousands) | Segment Gross Profit (Q1 2024, in thousands) | | :---------------- | :------------------------------ | :------------------------------------------- | | Device Protection | $2,357 | $1,628 | | Women's Health | $3,567 | $1,567 | | Cardiovascular | $770 | $497 | | Total | $6,694 | $3,692 | - One customer in the Women's Health segment represented **15%** of total net sales in Q1 2025 and **17%** in Q1 2024[138](index=138&type=chunk)[139](index=139&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=43&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on Elutia Inc.'s financial condition and operational results for the three months ended March 31, 2025, compared to the prior year. It details the company's business overview, the impact of discontinued operations and product recalls, a breakdown of revenue and expenses, and an analysis of liquidity and capital resources, including ongoing concerns about profitability and funding requirements [Overview](index=43&type=section&id=Overview) - Elutia's mission is to humanize medicine by leveraging biologics and local drug delivery to reduce complications with implanted medical devices, focusing on **Device Protection** (EluPro, CanGaroo) and **Women's Health** (SimpliDerm) markets[142](index=142&type=chunk)[144](index=144&type=chunk)[145](index=145&type=chunk)[146](index=146&type=chunk) - **EluPro**, cleared by the FDA in **June 2024** and fully launched in **January 2025**, is the only drug-eluting biomatrix (DEB) in the U.S. implantable electronic device protection market, designed to mitigate infection and other complications[145](index=145&type=chunk)[153](index=153&type=chunk) - The company utilizes a direct sales force and commercial partners (Boston Scientific for Device Protection, Tiger Aesthetics Medical for Women's Health) for product distribution, and plans to expand DEB offerings and internal production capabilities at a new Gaithersburg, MD facility by **Q4 2025**[149](index=149&type=chunk)[150](index=150&type=chunk)[151](index=151&type=chunk)[152](index=152&type=chunk) [Discontinued Operations – Sale of Orthobiologics Business](index=45&type=section&id=Discontinued%20Operations%20%E2%80%93%20Sale%20of%20Orthobiologics%20Business) - The sale of the Orthobiologics Business to Berkeley Biologics, LLC was completed in **November 2023**, yielding **$14.6 million** upfront and potential earn-out payments of up to **$20 million** over **five years**, with a **$1.5 million** indemnity holdback[154](index=154&type=chunk)[155](index=155&type=chunk)[156](index=156&type=chunk) - Elutia retained liabilities for the FiberCel and VBM product recalls, which were part of the divested Orthobiologics Business[156](index=156&type=chunk) [Product Recalls](index=47&type=section&id=Product%20Recalls) - Voluntary recalls were issued for **FiberCel** (**June 2021**) and a **VBM product** (**July 2023**) due to post-surgical tuberculosis infections, both of which were part of the divested Orthobiologics Business[157](index=157&type=chunk) [Components of Our Results of Operations](index=47&type=section&id=Components%20of%20Our%20Results%20of%20Operations) - Net sales are generated from **Device Protection**, **Women's Health**, and **Cardiovascular** products, distributed through direct sales, commercial partners, and independent sales agents[158](index=158&type=chunk) - Operating expenses include Cost of Goods Sold (raw materials, processing, manufacturing overhead, intangible amortization), Sales and Marketing (direct sales force, commissions, distribution), General and Administrative (compensation, legal, public company costs), Research and Development (salaries, supplies, clinical studies), and Litigation Costs, net (legal fees, settlement costs offset by insurance)[160](index=160&type=chunk)[161](index=161&type=chunk)[162](index=162&type=chunk)[163](index=163&type=chunk)[164](index=164&type=chunk) - Future R&D efforts will focus on expanding **EluPro** offerings, developing new DEB products, and conducting clinical studies to support commercialization[163](index=163&type=chunk) [Results of Operations (Comparison of the Three Months Ended March 31, 2025 and 2024)](index=50&type=section&id=Results%20of%20Operations%20(Comparison%20of%20the%20Three%20Months%20Ended%20March%2031%2C%202025%20and%202024)) [Net Sales](index=50&type=section&id=Net%20Sales) Net Sales by Product Category | Product Category | Q1 2025 Net Sales (in thousands) | Q1 2024 Net Sales (in thousands) | Change ($) | Change (%) | | :--------------- | :----------------------------- | :----------------------------- | :--------- | :--------- | | Device Protection | $3,079 | $2,357 | $722 | 30.6% | | Women's Health | $2,625 | $3,567 | $(942) | (26.4)% | | Cardiovascular | $326 | $770 | $(444) | (57.7)% | | Total Net Sales | $6,030 | $6,694 | $(664) | (9.9)% | - Total net sales decreased by **$0.7 million** (**9.9%**) year-over-year, driven by volume declines in Women's Health and Cardiovascular, partially offset by growth in Device Protection from EluPro's commercial launch[167](index=167&type=chunk) [Cost of Goods Sold](index=52&type=section&id=Cost%20of%20Goods%20Sold) Cost of Goods Sold and Gross Margin | Metric | Q1 2025 (in thousands) | Q1 2024 (in thousands) | Change ($) | Change (%) | | :------------------------------------------ | :--------------------- | :--------------------- | :--------- | :--------- | | Total Cost of Goods Sold | $3,573 | $3,851 | $(278) | (7.2)% | | Gross margin | 40.7% | 42.5% | (1.8)% | N/A | | Gross margin, excluding intangible asset amortization | 54.8% | 55.2% | (0.4)% | N/A | - Cost of goods sold decreased by **$0.3 million**, with gross margin declining slightly to **40.7%** (from **42.5%**). Women's Health gross margin increased due to fewer non-recurring write-offs, while Device Protection gross margin declined with the addition of EluPro, which currently has a lower margin[169](index=169&type=chunk) [Operating Expenses](index=52&type=section&id=Operating%20Expenses) Operating Expenses Breakdown | Expense Category | Q1 2025 (in thousands) | Q1 2024 (in thousands) | Change ($) | Change (%) | | :------------------------ | :--------------------- | :--------------------- | :--------- | :--------- | | Sales and marketing | $3,031 | $3,309 | $(278) | (8.4)% | | General and administrative | $3,871 | $5,056 | $(1,185) | (23.4)% | | Research and development | $905 | $1,172 | $(267) | (22.8)% | | Litigation costs, net | $2,572 | $1,785 | $787 | 44.1% | | Total operating expenses | $10,379 | $11,322 | $(943) | (8.3)% | - Sales and marketing, G&A, and R&D expenses all decreased, primarily due to lower non-cash equity compensation and reduced legal fees (G&A) and outside testing services (R&D) post-EluPro FDA clearance[170](index=170&type=chunk)[171](index=171&type=chunk)[172](index=172&type=chunk) - Litigation costs, net, increased by **44.1%** to **$2.6 million**, mainly because insurance coverage for FiberCel Litigation defense costs was available in Q1 2024 but not in Q1 2025[174](index=174&type=chunk) [Interest Expense](index=54&type=section&id=Interest%20Expense) Interest Expense Summary | Metric | Q1 2025 (in thousands) | Q1 2024 (in thousands) | Change ($) | Change (%) | | :--------------- | :--------------------- | :--------------------- | :--------- | :--------- | | Interest expense | $1,085 | $1,313 | $(228) | (17.4)% | - Interest expense decreased by **$0.2 million**, primarily due to lower principal outstanding on the SWK debt following mandatory repayments related to the Orthobiologics Business sale[175](index=175&type=chunk) [Other Expense (Income), net](index=54&type=section&id=Other%20Expense%20(Income)%2C%20net) Other Expense (Income) Summary | Metric | Q1 2025 (in thousands) | Q1 2024 (in thousands) | Change ($) | Change (%) | | :--------------- | :--------------------- | :--------------------- | :--------- | :--------- | | Other expense (income), net | $105 | $(1,443) | $1,548 | NM | - Other expense (income), net, shifted from an income of **$1.4 million** in Q1 2024 (due to a gain on revaluation of the Revenue Interest Obligation) to an expense of **$0.1 million** in Q1 2025 (due to transaction fees for 2025 Prefunded Warrants)[176](index=176&type=chunk)[177](index=177&type=chunk) [Non-GAAP Financial Measures](index=54&type=section&id=Non-GAAP%20Financial%20Measures) - The company presents gross margin, excluding intangible asset amortization, as a non-GAAP measure to provide supplemental information on operating performance by removing amortization expense[178](index=178&type=chunk) Non-GAAP Gross Margin Reconciliation | Metric | Q1 2025 | Q1 2024 | | :------------------------------------------ | :------ | :------ | | Gross margin | 40.7% | 42.5% | | Gross margin, excluding intangible asset amortization | 54.8% | 55.2% | [Seasonality](index=56&type=section&id=Seasonality) - The company historically experiences seasonality with higher sales in the **fourth quarter** (due to hospital budget cycles and patient deductibles) and lower sales in the **first quarter** (due to re-established patient deductibles)[182](index=182&type=chunk) [Liquidity and Capital Resources](index=56&type=section&id=Liquidity%20and%20Capital%20Resources) - As of March 31, 2025, cash and cash equivalents totaled **$17.4 million**, with an accumulated deficit of **$233.5 million**, indicating substantial doubt about the company's ability to continue as a **going concern** within **one year**[183](index=183&type=chunk)[190](index=190&type=chunk) - The company raised capital through a **$15.0 million** registered direct offering in **February 2025** and a **$13.3 million** registered direct offering in **June 2024**, involving Class A common stock and prefunded warrants[184](index=184&type=chunk)[185](index=185&type=chunk) Cash Flow Summary | Cash Flow Activity | Q1 2025 (in thousands) | Q1 2024 (in thousands) | | :----------------------- | :--------------------- | :--------------------- | | Operating activities | $(8,881) | $(2,641) | | Investing activities | $(278) | $(15) | | Financing activities | $13,278 | $(4,069) | | Net increase (decrease) in cash | $4,119 | $(6,725) | - Net cash used in operating activities increased to **$8.9 million** in Q1 2025, primarily due to higher trade obligation paydowns and **$3.0 million** in FiberCel settlement payments[193](index=193&type=chunk) - Net cash provided by financing activities was **$13.3 million** in Q1 2025, mainly from the 2025 Registered Offering, contrasting with cash used in Q1 2024 due to debt and revenue interest obligation repayments[196](index=196&type=chunk) - The SWK Loan Facility had **$24.3 million** outstanding as of March 31, 2025, and was amended in **May 2025** to allow PIK interest, remove mandatory prepayments from asset sales, and fix the minimum liquidity covenant at **$8.0 million**[197](index=197&type=chunk)[198](index=198&type=chunk)[208](index=208&type=chunk) - The Ligand Revenue Interest Obligation was further amended in **May 2025**, satisfying **$2.2 million** in royalty obligations through the issuance of **1,105,528 shares** of Class A common stock[209](index=209&type=chunk)[210](index=210&type=chunk) - Future funding requirements are significant due to ongoing commercialization of **EluPro**, product development, clinical activities, and public company operating costs, with potential capital raises through equity, debt, or asset sales[211](index=211&type=chunk)[212](index=212&type=chunk)[214](index=214&type=chunk) [Critical Accounting Policies and Estimates](index=66&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) - No material changes to critical accounting policies and estimates were reported during the three months ended March 31, 2025, other than those outlined in Note 2[215](index=215&type=chunk) [Recent Accounting Pronouncements](index=68&type=section&id=Recent%20Accounting%20Pronouncements) - Information regarding recently issued accounting pronouncements is detailed in Note 3 to the condensed consolidated financial statements[217](index=217&type=chunk) [JOBS Act](index=68&type=section&id=JOBS%20Act) - As an 'emerging growth company,' Elutia Inc. has elected to use the extended transition period for adopting new or revised accounting standards, which may result in financial statements not being comparable to those of public companies complying with earlier effective dates[218](index=218&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=68&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section discusses Elutia Inc.'s exposure to market risks, including interest rate risk, credit risk, and foreign currency risk, and their potential impact on the company's financial condition and results of operations - The company's primary market risk exposure is to changes in interest rates, particularly on its variable-rate SWK Loan Facility, though a hypothetical 10% change would not materially affect financial statements[221](index=221&type=chunk) - Credit risk exists as cash balances with financial institutions may exceed federally insured limits, but these institutions are believed to have sufficient assets and liquidity[222](index=222&type=chunk) - Foreign currency risk is currently minimal as business is primarily conducted in U.S. dollars, but exposure could increase with operational growth[223](index=223&type=chunk) [Item 4. Controls and Procedures](index=70&type=section&id=Item%204.%20Controls%20and%20Procedures) This section confirms that Elutia Inc.'s management, including the CEO and CFO, evaluated the effectiveness of its disclosure controls and procedures as of March 31, 2025, concluding they were effective, and reported no material changes in internal control over financial reporting during the quarter - The company's disclosure controls and procedures were evaluated and deemed effective as of March 31, 2025[226](index=226&type=chunk) - There were no material changes in internal control over financial reporting during the three months ended March 31, 2025[227](index=227&type=chunk) [PART II – OTHER INFORMATION](index=70&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) This section provides additional information on legal proceedings, risk factors, equity sales, and exhibits [Item 1. Legal Proceedings](index=70&type=section&id=Item%201.%20Legal%20Proceedings) This section refers to Note 9 of the condensed consolidated financial statements for detailed information on legal proceedings, acknowledging the inherent uncertainty of their outcomes - Information regarding legal proceedings, including the FiberCel, VBM, and Medtronic litigations, is detailed in Note 9 to the condensed consolidated financial statements[229](index=229&type=chunk) [Item 1A. Risk Factors](index=70&type=section&id=Item%201A.%20Risk%20Factors) This section states that there have been no material changes to the risk factors previously disclosed in the company's Annual Report, which could materially and adversely affect its business, financial condition, operating results, and stock price - No material changes to the risk factors disclosed in the Annual Report have occurred[230](index=230&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=70&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section reports that there were no unregistered sales of equity securities or use of proceeds during the period - No unregistered sales of equity securities or use of proceeds occurred during the period[231](index=231&type=chunk) [Item 3. Defaults Upon Senior Securities](index=70&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section indicates that there were no defaults upon senior securities during the reporting period - No defaults upon senior securities were reported[232](index=232&type=chunk) [Item 4. Mine Safety Disclosures](index=72&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section states that mine safety disclosures are not applicable to the company - Mine safety disclosures are not applicable to the company[233](index=233&type=chunk) [Item 5. Other Information](index=72&type=section&id=Item%205.%20Other%20Information) This section confirms that no directors or officers adopted or terminated any Rule 10b5-1 trading arrangements during the three months ended March 31, 2025 - No directors or officers adopted or terminated any Rule 10b5-1 trading arrangements during the three months ended March 31, 2025[234](index=234&type=chunk) [Item 6. Exhibits](index=73&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of the Quarterly Report on Form 10-Q, including various agreements, certificates, and certifications - The report includes exhibits such as the Asset Purchase Agreement, Restated Certificate of Incorporation, Amended and Restated Bylaws, various warrant forms (SWK, Common, Prefunded), and certifications[236](index=236&type=chunk)[237](index=237&type=chunk)[238](index=238&type=chunk)[240](index=240&type=chunk) [SIGNATURES](index=77&type=section&id=SIGNATURES) This section contains the official signatures of the President, Chief Executive Officer, and Chief Financial Officer - The report is signed by C. Randal Mills, Ph.D., President and Chief Executive Officer, and Matthew Ferguson, Chief Financial Officer, on **May 13, 2025**[244](index=244&type=chunk) ```

Financial Data and Key Metrics Changes - The company reported a total revenue of $6 million for Q1 2025, down from $7 million in the previous year but up 10% sequentially from Q4 2024 [33][34][38] - The adjusted gross margin was 54.8%, slightly down from 55.2% year-over-year, but expected to improve with operational efficiencies [36][37] - Adjusted EBITDA for the quarter was $3.3 million, an improvement from $4.5 million in the previous year [37] Business Line Data and Key Metrics Changes - The BioEnvelope division generated $3.1 million in revenue, representing a 31% year-over-year growth and a 16% sequential increase [33][34] - Simploderm revenue was $2.6 million, down from $3.6 million year-over-year but up 13% from Q4 2024 [34] - The cardiovascular products division reported $300,000 in sales, with expectations for significant growth as the company takes back control of sales efforts [35] Market Data and Key Metrics Changes - The company has secured contracts with 125 hospitals actively ordering Elupro, with an additional 130 Value Analysis Committees (VACs) in process [11][12] - The partnership with Boston Scientific has expanded the sales force to 900 representatives, enhancing market penetration [18][20] Company Strategy and Development Direction - The primary focus is on driving top-line growth for Elupro through expanding VAC and Group Purchasing Organization (GPO) coverage [41] - The company plans to explore strategic alternatives for its Simploderm product line and advance its drug-eluting biologic pipeline [42][43] - A new facility in Gaithersburg, Maryland, is expected to alleviate production bottlenecks and reduce costs [22][23] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about a strong second half of 2025, driven by the successful launch of Elupro and the partnership with Boston Scientific [13][41] - The company is focused on increasing production capacity and lowering costs to achieve gross margins in the mid-70% range [42] Other Important Information - The company received an Edison Award for innovation in post-surgical recovery for Elupro [27] - A real-world clinical study has begun, with the first patients enrolled at UCSD, aimed at gathering clinical outcome data [27][61] Q&A Session Summary Question: How have relationships with physicians gone in accounts selling with Boston Scientific? - Management noted that adoption patterns for Elupro are positive, with initial orders often leading to higher subsequent orders as physicians experience the product [49][50] Question: What is the current manufacturing capacity without the Gaithersburg facility? - Current manufacturing capacity allows for approximately $140 million in Elupro revenue, but without the antibiotic disc expansion, it is constrained to $25 million to $30 million [54] Question: What is the expected cash burn profile going forward? - The cash flow statement is expected to show operational cash flow around $4 million to $5 million after Q2, following the settlement of litigation costs [56][57] Question: How will the registry study support commercial conversions? - The registry study is anticipated to be more impactful in the second half of next year, aiding in regulatory submissions and enhancing the VAC process [60][61] Question: What is the expected revenue growth for Elupro compared to Kangaroo? - Elupro is projected to reach approximately $200 million in U.S. revenue at maturity, significantly surpassing Kangaroo's $10 million at maturity [63][64]