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01/11 03:33
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call reveals solid financial management, with improved cash flow and reduced operating losses. The company's commitment to a 50% growth target and strategic investments in new applications and products support a positive outlook. Despite management's reluctance to provide 2026 guidance, the market strategy and product development updates are favorable. The Q&A highlights robust feedback and growth in new applications, enhancing the sentiment. The positive aspects outweigh the lack of long-term guidance, suggesting a potential stock price increase in the short term.
Revenue $11.6 million, representing 57% increase year-over-year and 3% sequential gain over the second quarter of 2025. The increase was attributed to the exceptional performance of the commercial team and the expanding adoption of the TriNav for liver embolization procedures.
Gross Margin 84%, compared to 86% in the prior year period. The modest decline was primarily due to lower manufacturing efficiency associated with newly launched products, which is expected to improve in the fourth quarter as production stabilizes.
Research and Development (R&D) Expenses $5.2 million, up from $4.2 million in the third quarter of 2024. The increase was largely due to a onetime charge of approximately $2.1 million related to the closure of clinical studies for nelitolimod, partially offset by a revision of approximately $700,000 in patent-related costs to general and administrative expenses. Excluding the onetime charge and revision, R&D spend was down about $400,000 year-over-year.
Sales and Marketing Expenses $6.8 million, compared to $6.1 million in the prior year. The increase was primarily due to higher performance-based compensation reflected by strong commercial momentum.
General and Administrative (G&A) Expenses $6.7 million, up from $4.7 million in the third quarter of 2024. The increase was driven mainly by the acceleration of approximately $1.6 million in noncash stock-based compensation and the revision of approximately $700,000 of patent-related expenses. Excluding the onetime accelerated stock-based compensation and revision of patents, G&A was down $300,000 year-over-year.
Operating Loss $9 million, compared to $8.7 million in the prior year. The increase was primarily driven by the onetime charge related to the closure of clinical studies for nelitolimod and the noncash stock-based compensation acceleration in the period.
Cash Used in Operations $3.7 million, a substantial improvement versus $11.2 million in the third quarter of 2024. This improvement reflects stronger sales performance, lower underlying R&D spend, and disciplined operating expense management.
Adjusted EBITDA Loss $5.4 million, an improvement from $7.1 million in the prior year. This includes approximately $2.1 million in onetime charges related to the PERIO study closeout. The improvement reflects stronger sales performance, lower underlying R&D spend, and disciplined operating expense management.
Cash and Cash Equivalents $22.7 million at the end of the quarter. This provides ample liquidity to fund operations and strategic objectives.
TriNav FLX infusion system: Launched to expand market opportunities and advance new clinical applications.
TriNav XP: Next-generation product with compatibility for larger particles and a flexible distal tip, aimed at liver and uterine artery embolization procedures. Early feedback from over 20 cases has been positive.
TriNav LV and TriGuide: Launched to improve therapeutic delivery precision and address vascular challenges.
Liver embolization market: Deeper penetration achieved, supported by CMS HCPCS code C8004, which expanded reimbursement for simulation angiogram or mapping procedures using TriNav.
Uterine fibroid treatment: Market evaluation initiated for TriNav Infusion System, addressing unmet needs in uterine fibroid treatment.
Knee osteoarthritis: Pilot registry and clinical trial initiated for genicular artery embolization (GAE) using TriNav, targeting pain management and mobility preservation.
Revenue growth: Achieved $11.6 million in Q3 2025, a 57% year-over-year increase and 3% sequential growth.
Gross margin: Reported at 84%, slightly down due to lower manufacturing efficiency of new products.
Cash management: Cash used in operations reduced to $3.7 million, with a quarter-end cash balance of $22.7 million.
PEDD technology: Continued investment in Pressure-Enabled Drug Delivery (PEDD) technology for solid tumors and interventional treatments.
Nelitolimod program: Transitioning to partnerships to reduce development expenses while preserving potential upside.
Clinical studies: Enrollment completed for Phase I trials in multiple liver tumor types and pancreatic cancer, with data releases expected in Q4 2025.
Macroeconomic Conditions and Global Events: The company acknowledges material risks and uncertainties, including the impact of macroeconomic conditions and global events, which could cause actual results or events to materially differ from expectations.
Extended Timeline to EBITDA Positive: The deliberate decision to increase commercial investment to maintain growth has extended the timeline to reach EBITDA positive and cash flow breakeven, which could strain financial resources.
Manufacturing Efficiency: Lower manufacturing efficiency associated with newly launched products has led to a modest decline in gross margin, which could impact profitability if not addressed.
Clinical Study Closures: The closure of clinical studies for nelitolimod resulted in a one-time charge of $2.1 million, reflecting potential challenges in managing R&D expenditures.
Debt Agreement and Cash Covenant: The amendment to reduce the minimum cash covenant from $10 million to $5 million provides flexibility but also indicates potential liquidity concerns.
Revenue Growth: Reaffirmed 50% revenue growth guidance, reflecting strong confidence in growth momentum and market opportunities.
Product Development: Continued investment in expanding the TriNav platform, including the launch of TriNav FLX infusion system and market evaluation of TriNav XP. Feedback from initial cases with TriNav XP has been positive, highlighting advancements in trackability, visualization, and efficiency.
Clinical Applications: Expanding clinical applications of TriNav Infusion System to uterine fibroids, thyroid nodules, and knee osteoarthritis. Enrollment continues in the PROTECT registry and a pilot registry for genicular artery embolization (GAE). A clinical trial for GAE in knee osteoarthritis is being prepared.
Partnerships: Advancing partnership discussions for nelitolimod to maximize its long-term value across oncology indications. Transitioning to partnerships will reduce development-related expenses by the end of 2025.
Operational Focus: Focus on advancing PEDD solutions, improving manufacturing efficiency, and enhancing operational performance to improve gross margins.
Clinical Data and Evidence: Generating and publishing new clinical and health economic outcomes research (HEOR) data to validate the effectiveness, safety, and economic value of the technology.
Financial Management: Amended debt agreement to reduce minimum cash covenant, providing additional balance sheet flexibility. Cash and cash equivalents at $22.7 million, with sufficient liquidity to fund operations and strategic objectives.
The selected topic was not discussed during the call.
The earnings call reveals solid financial management, with improved cash flow and reduced operating losses. The company's commitment to a 50% growth target and strategic investments in new applications and products support a positive outlook. Despite management's reluctance to provide 2026 guidance, the market strategy and product development updates are favorable. The Q&A highlights robust feedback and growth in new applications, enhancing the sentiment. The positive aspects outweigh the lack of long-term guidance, suggesting a potential stock price increase in the short term.
The earnings call highlighted strong financial performance with a 42% sales increase and a 50% growth guidance for 2025. Product innovations and successful reimbursement progress are positive indicators. Despite operating losses, improved EBITDA and cash position provide stability. The Q&A revealed positive market reception for new products and mapping technology, with strategic investments in sales expected to drive growth. However, uncertainties in partnership discussions and unclear timelines for nelitolimod present some risks. Overall, the positive financials, growth trajectory, and market reception outweigh the uncertainties, suggesting a positive stock price movement.
The earnings call revealed mixed signals: strong revenue growth and reduced losses, but ongoing financial challenges and competitive pressures. The Q&A highlighted positive feedback on products and expansion efforts but also showed management's reluctance to provide clear guidance, raising concerns. The private placement and preferred share exchange offer could dilute stock value. Overall, the company's strategic initiatives and product performance are promising, but financial uncertainties and competitive challenges temper the outlook, resulting in a neutral sentiment.
The earnings call presents a generally positive outlook with strong revenue growth and reduced losses. The Q&A section reveals favorable feedback on new products and strategic initiatives, although some management responses lacked clarity. The strategic partnership focus and cash infusion from a private placement support growth prospects. Despite slight gross margin decline, the overall sentiment remains positive, driven by significant revenue growth and operational improvements. The absence of market cap information limits the prediction's precision, but the positive indicators suggest a stock price increase in the short term.
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