Elutia(ELUT)

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Elutia(ELUT) - 2025 Q1 - Earnings Call Transcript
2025-05-08 22:02
Financial Data and Key Metrics Changes - The company reported a total revenue of $6 million for the first quarter, down from $7 million a year ago but up 10% sequentially from the previous quarter [33][34][38] - The adjusted gross margin was 54.8%, slightly down from 55.2% year over year, but expected to improve as efficiencies in manufacturing are realized [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 a year ago but up 13% from the previous quarter [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 Value Analysis Committee (VAC) approvals from 125 hospitals, with an additional 130 VACs in process [11][12] - The partnership with Boston Scientific has expanded the sales force to over 900 representatives, enhancing market reach [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 [42] - There is an ongoing effort to advance the drug-eluting biologic pipeline for reconstructive surgery [44] 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 for Elupro, targeting gross margins in the mid-70% range [42][43] Other Important Information - The company opened a new facility in Gaithersburg, Maryland, to enhance manufacturing capacity for critical components, which is expected to reduce costs [22][23] - The company received an Edison Award for innovation in post-surgical recovery for Elupro [27] Q&A Session Summary Question: How have relationships with physicians gone in those cases with Boston Scientific? - Management noted that adoption patterns for Elupro are positive, with initial orders often leading to higher subsequent orders as more physicians in practices begin to use 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 new facility, capacity would be constrained to $25 million to $30 million [54] Question: What should be expected regarding cash burn going forward? - Cash flow from operations is expected to stabilize around $4 million to $5 million after Q2, following the settlement of litigation costs [56][57] Question: How will the registry study data support commercial conversions? - The data from 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 for Elupro as it matures? - Elupro is projected to reach approximately $200 million in U.S. revenue at maturity, significantly surpassing the previous product, Kangaroo [63][64]
Elutia(ELUT) - 2025 Q1 - Earnings Call Transcript
2025-05-08 22:00
Financial Data and Key Metrics Changes - The company reported Q1 2025 revenue of $6,000,000, down from $7,000,000 in Q1 2024 but up 10% sequentially from Q4 2024 [33][34][36] - Adjusted gross margin for Q1 2025 was 54.8%, slightly down from 55.2% in the previous year, with expectations for improvement as efficiencies are realized [35][36] - Adjusted EBITDA for Q1 2025 was $3,300,000, an improvement from $4,500,000 in the previous year [37] Business Line Data and Key Metrics Changes - The BioEnvelope division generated $3,100,000 in revenue, representing a 31% year-over-year growth and a 16% sequential increase [10][33] - Simploderm revenue was $2,600,000, down from $3,600,000 year-over-year but up 13% from Q4 2024 [34] - Cardiovascular products division reported $300,000 in sales, with expectations for significant growth as the company takes back control of sales [35][36] 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 [12][13] - 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 for reconstructive surgery [42][44] - The new Gaithersburg facility will enhance production capacity and reduce costs by manufacturing critical components in-house [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 [14][41] - The company is focused on increasing production capacity and lowering costs to achieve gross margins in the mid-seventy percent 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 commenced, with the first patients enrolled at UCSD, aimed at gathering clinical outcome data [27][60] Q&A Session Summary Question: How have relationships with physicians gone in those cases with Boston Scientific? - Adoption patterns for Elupro show that initial orders are often followed by higher subsequent orders, indicating strong physician interest and usage [48][50] Question: What is the current manufacturing capacity without the Gaithersburg facility? - Current manufacturing capacity allows for approximately $140,000,000 in Elupro revenue, but without the antibiotic disc expansion, it is limited to $25,000,000 to $30,000,000 [53] Question: What should be expected regarding cash burn going forward? - Cash flow from operations is expected to stabilize around $4,000,000 to $5,000,000 as litigation settlements conclude [55][56]
Elutia(ELUT) - 2025 Q1 - Earnings Call Presentation
2025-05-08 21:23
Financial Performance - EluPro sales experienced significant sequential growth of 84%, now representing 52% of BioEnvelope revenue[8, 11] - BioEnvelope revenue increased by 31% year-over-year, reaching $3.1 million[11] - The company's cash balance as of March 31, 2025, was $17.4 million[29] - A registered direct offering generated gross proceeds of $15.0 million on February 4, 2025[29] Strategic Initiatives - A strategic partnership with Boston Scientific aims to accelerate EluPro adoption, leveraging a combined commercial footprint of over 900 sales professionals[8, 15, 16] - The company reacquired distribution rights for its cardiovascular portfolio from LeMaitre, expecting it to contribute to cash flow with approximately 80% gross margin[8, 24, 27] Operational Improvements - The company is focused on increasing production capacity and reducing COGS for EluPro[17, 33] - The Roswell, GA facility has scalable capacity to support approximately $140 million in EluPro sales at over 70% gross margin[20] Market Expansion - Elutia is targeting approximately 1,000 hospitals with Cardiac Implantable Electronic Devices (CIED) volumes exceeding 100 cases per year[14] - Elutia is actively engaging with hospitals, with 125 institutions actively ordering and 130 Value Analysis Committees (VACs) in process, adding 10-12 institutions per month[11, 14]
Elutia(ELUT) - 2025 Q1 - Quarterly Results
2025-05-08 20:25
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 fi ...
Elutia Announces Strong First Quarter 2025 Financial Results Driven by 84% Sequential Growth in EluPro™ Sales
Globenewswire· 2025-05-08 20:05
Core Insights - Elutia Inc. reported strong first-quarter results for 2025, highlighting the successful launch and adoption of its EluPro™ product, which has established itself as a significant solution for cardiac implantable electronic device (CIED) procedures [1][4]. Business Highlights - EluPro experienced an 84% sequential sales increase, contributing to a 31% year-over-year growth in BioEnvelope revenue, totaling $3.1 million, with EluPro accounting for approximately 52% of BioEnvelope sales [4][5]. - The partnership with Boston Scientific is expected to enhance the adoption of EluPro, with over 900 sales professionals involved and initial training completed, leading to sales generation in over 50 hospitals [3][4]. - EluPro's marketing efforts include a prominent presence at the Heart Rhythm Society 2025 and a new national campaign aimed at increasing awareness [4]. - EluPro received a 2025 Edison Award for innovation, and new peer-reviewed data has validated its antibacterial efficacy [4]. Financial Performance - Total net sales decreased by 10% to $6.0 million compared to $6.7 million in Q1 2024, with BioEnvelope products showing a 31% increase [5][9]. - Gross margin on a GAAP basis was 40.7%, down from 42.5%, while adjusted gross margin was 54.8%, slightly down from 55.2% [9][17]. - The company reported a loss from operations of $7.9 million, an improvement from a loss of $8.5 million in the previous year [9][16]. Strategic Developments - Elutia regained full commercial rights to its ProxiCor™, Tyke™, and VasCure™ products, which are now sold through a contractor-based model expected to enhance cash flow [4]. - The company raised $15 million through a registered direct offering and amended loan terms to improve financial flexibility [4].
Elutia Transitions to Direct Distribution of Its Cardiovascular Product Portfolio
Globenewswire· 2025-05-01 20:05
Core Insights - Elutia Inc. is reclaiming U.S. sales and distribution responsibilities for its cardiovascular portfolio, which includes ProxiCor®, VasCure®, and Tyke®, after ending its distribution agreement with LeMaitre Vascular, Inc. This strategic move is expected to enhance top-line revenue and improve gross margins and profitability for this product segment [1][4] Company Developments - Dwayne Montgomery has been appointed as Head of Cardiovascular to lead the newly established business unit, bringing extensive experience from previous roles at Osiris Therapeutics, Smith & Nephew, Guidant, and C.R. Bard [2] - Under Montgomery's leadership, Elutia has assembled a team of 26 independent sales representatives dedicated to the cardiovascular line, allowing for focused operations separate from the EluPro™ commercial organization [3] Financial Expectations - The cardiovascular portfolio is projected to deliver approximately 80% gross margins and maintain a premium price position in the market. In 2024, sales from cardiovascular products accounted for $2.9 million, representing about 12% of total revenue [4]
Elutia to Report First Quarter 2025 Financial Results on Thursday, May 8, 2025
Globenewswire· 2025-05-01 12:00
SILVER SPRING, Md., May 01, 2025 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix technologies, today announced that it will release its first quarter 2025 financial results after market close on Thursday, May 8, 2025. Members of the Company’s management team will host a conference call and webcast starting at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time on the same day. The conference call can be accessed using the following information: Web ...
Elutia to Participate in Chardan's Trending Issues in Drug Development Conference Series on April 29
GlobeNewswire News Room· 2025-04-22 20:05
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. SILVER SPRING, Md., April 22, 2025 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) ("Elutia"), a pioneer in drug-eluting biomatrix technologies, today announced t ...
Elutia Initiates EluPro™ Registry Study Designed to Generate Evidence Supporting the Use of EluPro in Real-World Clinical Practice
Globenewswire· 2025-04-21 12:00
— Integration of clinical and patient-reported outcomes expected to further differentiate EluPro's utility in cardiac implantable electronic device (CIED) procedures — SILVER SPRING, Md., April 21, 2025 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) ("Elutia" or the "Company"), a pioneer in drug-eluting biomatrix technologies, today announced the initiation of an EluPro™ clinical study designed to collect patient outcome data in real-world clinical practice. EluPro, the first and only FDA-cleared antibiotic ...
Elutia Confirms No Material Impact from Global Tariffs
Globenewswire· 2025-04-14 12:00
SILVER SPRING, Md., April 14, 2025 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix products, today confirmed that the ongoing global tariff environment has had no material impact on its commercial or operational performance. Elutia sources, manufactures, and distributes 100% of its products within the United States, primarily from its Roswell, Georgia production facility and U.S.-based suppliers. These products include EluPro™, CanGaroo®, Simpl ...