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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 Delivers Robust Growth on the Strength of EluPro™ Market Adoption
Globenewswire· 2025-08-14 20:05
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]
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].