In 2000, Looking for Alibrandi, the debut movie by director Kate Woods, won best film at the Australian Film Institute (AFI) Awards.The much-loved coming-of-age movie, starring Pia Miranda and Anthony LaPaglia, landed a total of five awards, including best lead actress for Miranda.AFI rebranded to the Australian Academy of Cinema and Television Arts (AACTA), and this year Woods returns to its annual award night, the AACTAs, on February 6, off the back of what is only her second movie, Kangaroo.Read the full ...

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]

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]

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]

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]

Financial Data and Key Metrics Changes - In Q4 2024, bio envelope sales reached $2.7 million, representing an 18% growth year-over-year [56] - For the full year, bio envelope sales totaled $9.9 million, showing a solid growth of approximately 5% [56] - Simpliderm sales in Q4 were $2.3 million, down year-over-year, but for the full year, it was $11.6 million, up 12% [58] - Overall revenue for Q4 was $5.5 million, down about 7% year-over-year, while total revenue for the year was $24.4 million, down about 1% [60] - GAAP gross margin improved to 43% for Q4 compared to 36% in the prior year, and adjusted gross margin was 58% versus 51% year-over-year [61] Business Line Data and Key Metrics Changes - EluPro accounted for approximately 30% of bio envelope sales in Q4, marking a significant initial uptake [44] - The bio envelope sales rate, including Kangaroo and EluPro, increased by 18% in Q4, indicating a strong market response [43] - The company reported a 65% increase in sales at centers that switched from Kangaroo to EluPro, driven by repeat orders [45] Market Data and Key Metrics Changes - The U.S. market sees about 600,000 pacemakers and internal defibrillators implanted annually, with Medtronic holding a 40% market share [13][14] - Elutia's EluPro is positioned to capture a significant portion of the remaining 60% of the market, which is currently not served by antibiotic-eluting envelopes [15][16] Company Strategy and Development Direction - The company aims to prove the commercial value of EluPro, drive growth with Simpliderm, and expand drug-eluting biologics into other product lines [10][11] - Elutia is focused on operational excellence, obtaining hospital and GPO approvals, and driving clinical uptake of EluPro [24][25][26] - The company plans to initiate a rollout of EluPro with Boston Scientific, leveraging their distribution network to enhance market penetration [52] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong initial uptake of EluPro and the potential for significant growth in 2025 [56][58] - The company is actively engaged in strategic discussions with multiple partners to enhance its market position [27] - Management acknowledged the challenges faced in the Simpliderm product line due to the bankruptcy of a distribution partner but remains hopeful for recovery [93][96] Other Important Information - The company ended Q4 with $13.2 million in cash, with a significant cash usage attributed to settling outstanding lawsuits [64] - A registered direct offering raised $15 million in gross proceeds after the end of the quarter, bolstering the cash position [65] Q&A Session Summary Question: Can you discuss Boston's involvement with EluPro? - The agreement with Boston Scientific involves leveraging their 900 reps for distribution in the U.S., focusing on hospital access and product awareness [68][69] Question: When will Boston commence distribution? - Distribution will commence shortly [79] Question: How should we think about utilization at accounts? - High volume accounts are expected to have annual usage in the hundreds, with significant growth anticipated in Q1 [84][85] Question: What occurred during Q4 regarding Simpliderm's growth deceleration? - Simpliderm faced challenges due to the bankruptcy of Sientra, but the product still grew 12% year-over-year [96] Question: Can you discuss the structure of distribution agreements? - The agreement with Boston allows for potential future agreements with other pacemaker manufacturers, but current demand is being met with Boston [101][105] Question: What is the cadence of new account additions expected in 2025? - The current pace is about 15 new accounts per month, but this may slow due to varying VAC approval times [107][110] Question: Can you break down the cash burn in Q4? - Cash burn included operational expenses and litigation settlements, with a significant reduction in outstanding litigation liabilities [111][115]