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01/11 08:02
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call presents a positive outlook with strong financial improvements, reduced net loss, and promising trial data for Symvess, which is expected to drive future growth. The Q&A section highlights positive feedback from hospitals and surgeons, successful cost-saving measures, and strategic expansion plans. Despite some unclear responses, the overall sentiment is optimistic, supported by strong data and strategic initiatives, likely leading to a positive stock price movement.
Revenue for Q3 2025 $0.8 million, of which $0.7 million related to U.S. sales of Symvess. This is a significant increase compared to no revenue in Q3 2024. The increase is attributed to the commercial launch of Symvess and growing adoption by hospitals and healthcare systems.
Revenue for 9 months ended September 30, 2025 $1.6 million, of which $0.9 million related to U.S. sales of Symvess and $0.6 million from a research collaboration. There was no revenue for the same period in 2024. The increase is due to the commercial launch of Symvess and research collaborations.
Cost of Goods Sold (COGS) for Q3 2025 $0.3 million, compared to no COGS in Q3 2024. This includes overhead related to unused production capacity, reflecting the initial stages of commercial production.
Cost of Goods Sold (COGS) for 9 months ended September 30, 2025 $0.6 million, compared to no COGS in the same period in 2024. This reflects the costs associated with the commercial production of Symvess.
Research and Development (R&D) expenses for Q3 2025 $17.3 million, compared to $22.9 million in Q3 2024. The decrease is primarily due to the capitalization of material and overhead costs for commercial manufacturing and cost reductions implemented earlier in 2025.
Research and Development (R&D) expenses for 9 months ended September 30, 2025 $54.7 million, compared to $67.9 million in the same period in 2024. The decrease is due to reduced material costs, capitalization of inventory expenditures, and the winding down of certain clinical trial programs.
Selling, General, and Administrative (SG&A) expenses for Q3 2025 $7.6 million, compared to $7.3 million in Q3 2024. The increase is attributed to the U.S. commercial launch of Symvess, including increased personnel expenses.
Selling, General, and Administrative (SG&A) expenses for 9 months ended September 30, 2025 $23.6 million, compared to $18.4 million in the same period in 2024. The increase is due to expenses related to the commercial launch of Symvess.
Other Net Income for Q3 2025 $6.9 million, compared to a net expense of $9.0 million in Q3 2024. The increase is primarily due to the noncash remeasurement of the contingent earn-out liability from the 2021 merger.
Other Net Income for 9 months ended September 30, 2025 $61.3 million, compared to a net expense of $41.5 million in the same period in 2024. The increase is due to the noncash remeasurement of the contingent earn-out liability.
Net Loss for Q3 2025 $17.5 million, compared to $39.2 million in Q3 2024. The decrease is due to the noncash remeasurement of the contingent earn-out liability, reduced operating expenses, and a decrease in loss from operations.
Net Loss for 9 months ended September 30, 2025 $16.0 million, compared to $127.8 million in the same period in 2024. The decrease is attributed to the same factors as the quarterly reduction in net loss.
Symvess commercial launch: Traction gained with surgeons and hospitals; 92 civilian hospitals approved for purchase; $703,000 in product sales this quarter, up from $100,000 last quarter.
Symvess in military facilities: First commercial sale to U.S. military facilities after ECAT approval; interest in improving medical options for military personnel.
Symvess publications: Three studies published demonstrating effectiveness in vascular trauma, including hospital-acquired complications, wartime injuries in Ukraine, and comparison to autologous vein.
ATEV for dialysis access: Positive 2-year results from V007 Phase III trial; superior duration of use over 24 months compared to autogenous fistula; targeting underserved populations like women and high-risk men.
CTEV for coronary artery bypass grafting: Positive preclinical results; IND filed with FDA; first-in-human study planned for 2026.
Expansion into military healthcare: Symvess now available to military treatment facilities and U.S. Department of Veterans Affairs Hospitals.
Revenue growth: $0.8 million revenue this quarter, $0.7 million from Symvess sales, up from $0.1 million last quarter.
Cost management: Decreased R&D expenses due to capitalization of manufacturing costs and winding down of clinical trials.
Intellectual property expansion: New U.S. patent granted for bioengineered esophagus, providing protection until 2041.
Market Adoption Challenges: Despite progress in VAC approvals and increased product sales, the company faces challenges in achieving widespread adoption of Symvess, as evidenced by the ongoing review processes in 45 additional hospitals or health systems.
Regulatory and Approval Risks: The company’s plans to expand indications for its products, such as the ATEV for dialysis access, are contingent on successful interim analysis and regulatory approvals, which carry inherent risks of delays or non-approval.
Supply Chain and Production Costs: The cost of goods sold includes overhead related to unused production capacity, indicating potential inefficiencies or underutilization in manufacturing operations.
Financial Sustainability: The company reported a net loss of $17.5 million for Q3 2025 and $16.0 million for the first nine months of 2025, raising concerns about its ability to achieve profitability in the near term.
Competitive Pressures: Symvess faces competition from the current standard of care, autologous vein, which has established efficacy and safety profiles, potentially limiting market penetration.
Economic and Funding Risks: The company’s cash position, even after a recent stock and warrant sale, provides a runway of just over 12 months, highlighting the need for additional funding to sustain operations.
Commercial Expansion of Symvess: The company is actively engaging with surgeons and clinicians, observing increased hospital orders and reorders for Symvess. Symvess has been approved for purchase by 92 civilian hospitals, with 45 additional hospitals currently reviewing the product. The company anticipates further adoption and validation of Symvess through ongoing research and publications.
U.S. Defense Logistics Agency ECAT Approval: Symvess has been approved for the Electronic Catalog (ECAT) listing, making it available to healthcare professionals treating military personnel and veterans. The company has recorded its first commercial sale to U.S. military facilities and is advancing discussions with additional DoD-affiliated hospitals.
Dialysis Access Program: Positive 2-year results from the V007 Phase III trial of ATEV in dialysis patients were presented, showing superior duration of use over 24 months compared to autogenous fistula. Interim analysis results from the ongoing V012 Phase III trial are expected by April 2026, with plans to submit a supplemental BLA in the second half of 2026 to add dialysis access as an indication for ATEV.
Coronary Tissue Engineered Vessel (CTEV) Program: The company plans to advance the CTEV into a first-in-human study for coronary artery bypass grafting (CABG) in 2026. An IND has been filed with the FDA for this indication.
Intellectual Property Expansion: A new U.S. patent has been granted for the composition of a bioengineered esophagus, providing protection until 2041. This expands the company's tubular prosthesis patent family, which includes engineered trachea, urinary conduits, and esophagus.
The selected topic was not discussed during the call.
The earnings call presents a positive outlook with strong financial improvements, reduced net loss, and promising trial data for Symvess, which is expected to drive future growth. The Q&A section highlights positive feedback from hospitals and surgeons, successful cost-saving measures, and strategic expansion plans. Despite some unclear responses, the overall sentiment is optimistic, supported by strong data and strategic initiatives, likely leading to a positive stock price movement.
The earnings call reveals a mixed picture. Basic financial performance shows improvement with a net income for H1 2025, but the Q2 2025 net loss and decreased cash position are concerns. Product development is promising with Symvess launch and ongoing trials, but pricing adjustments may impact margins. Market strategy is sound, targeting military and civilian markets. However, the Q&A section highlights uncertainties in reimbursement and trial timelines. Overall, the mixed signals and lack of clear guidance suggest a neutral stock price movement in the short term.
The earnings call reveals strong financial performance, with EPS and revenue exceeding expectations. Although there are supply chain challenges and workforce reductions, the company has managed to reduce net losses and increase cash reserves. The launch of Symvess is progressing, and partnerships, such as with Fresenius, remain strong. Despite some concerns raised during the Q&A, overall sentiment is positive, especially with significant cost savings and a strong cash position. The stock is likely to react positively, potentially within the 2% to 8% range.
The earnings call presents a mixed picture. Financial performance shows a positive net income due to non-cash adjustments, yet revenue is low, raising concerns about future growth. Product development and market strategy are progressing, but initial sales are slow. The Q&A reveals ongoing challenges with VAC approvals and military hospital processes. Despite cost savings and a strong cash position, the public offering and workforce reductions may worry investors. The lack of a clear timeline for military hospital adoption and vague management responses contribute to uncertainty. Overall, the sentiment is neutral, with no strong catalysts for significant stock movement.
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