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01/11 16:16
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
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.
Net Sales $11.2 million, a 52% increase year-over-year and a 22% sequential gain over Q1 2025. The increase was driven by strong momentum in the liver embolization market and the launch of the TriNav FLX infusion system.
Gross Margin 84%, compared to 88% in Q2 2024. The decline was due to lower manufacturing efficiency associated with newly launched products, which is expected to improve as production scales.
Research and Development (R&D) Expenses $3.9 million, compared to $4.7 million in Q2 2024. The decrease was due to the ramp-down of nelitolimod clinical trial spending, with $500,000 of nonrecurring expenses related to the closeout of clinical trial sites.
Sales and Marketing Expenses $7.2 million, compared to $6 million in Q2 2024. The increase reflects investments in expanding the commercial organization to scale sales and marketing efforts.
General and Administrative (G&A) Expenses $5.7 million, compared to $4 million in Q2 2024. The increase was driven by $1 million of nonrecurring legal and audit professional service expenses.
Operating Losses $7.3 million, compared to $8.2 million in Q2 2024. The reduction was due to increased sales and reduced R&D expenses.
Adjusted EBITDA Loss $5.3 million, compared to $6.7 million in Q2 2024. The improvement was attributed to increased sales, reduced R&D expenses, and higher noncash stock-based compensation.
Cash and Cash Equivalents $26.5 million, including $22 million in gross proceeds from a private placement conducted in April. This provides sufficient liquidity to fund operations throughout 2025.
Launch of TriNav FLX infusion system: The TriNav FLX infusion system was launched, demonstrating improved trackability and engineered for use in torturous vascular anatomy. Initial sales exceeded internal projections.
Expansion of TriNav product portfolio: New devices like TriNav LD and TriGuide were introduced, enabling pressure-enabled drug delivery (PEDD) in larger vessels.
Development of new clinical applications: The PROTECT Registry was launched to evaluate PEDD for thyroid nodules, and a pilot registry for Genicular artery embolization (GAE) was initiated.
Increased adoption of TriNav: Gained further penetration in the liver embolization market and expanded into new clinical settings. CMS issued code C8004, doubling reimbursable use of TriNav.
Partnership discussions for nelitolimod: Shifted to a partnership-focused approach for nelitolimod development, eliminating development-related expenses by 2025.
Revenue growth: Achieved $11.2 million in net sales, a 52% increase year-over-year and 22% sequential growth.
Improved operational performance: Gross margin was 84%, with plans to improve manufacturing efficiency for new products.
Cost management: Reduced R&D expenses due to nelitolimod trial closures and streamlined G&A costs.
Focus on PEDD platform: Prioritized expanding the PEDD platform across multiple solid tumor types and interventional procedures.
Streamlined capital structure: Completed exchange offer and consent solicitation for preferred stock, simplifying the capital structure.
Macroeconomic Conditions and Global Events: Management highlighted material risks and uncertainties, including the impact of macroeconomic conditions and global events, which could adversely affect the company's results or events.
Manufacturing Efficiency: Gross margin declined year-over-year due to lower manufacturing efficiency associated with newly launched products. This is expected to improve as production scales, but currently poses a challenge.
R&D Expenditures: The company is reducing R&D expenditures by concluding nelitolimod-related expenses by year-end 2025. While this reduces costs, it may limit innovation in the short term.
Delayed Profitability: The company has delayed achieving EBITDA and cash flow positivity until 2026 due to investments in strategic areas, which could strain financial resources in the near term.
Regulatory and Reimbursement Challenges: Although new reimbursement codes have been issued, the company must ensure continued adoption and compliance, which could pose challenges.
Operational Costs: Increased general and administrative expenses, including nonrecurring legal and audit costs, have impacted financial performance. Streamlining these costs is planned but not yet realized.
Revenue Growth: The company reiterates its guidance of 50% revenue growth for 2025, reflecting confidence in future growth.
EBITDA and Cash Flow: The company expects to delay being EBITDA positive or cash flow positive until 2026, due to deliberate investments in strategic areas of the business.
R&D Expenditures: R&D expenditures are expected to reduce significantly in the second half of 2025, with no further development spend projected for 2026, as the company transitions to a partnership-focused approach for nelitolimod.
Product Development and Market Expansion: The company plans to continue investing in the TriNav product portfolio, including new devices tailored to future indications, to expand patient eligibility and support broader adoption.
Clinical Data and Market Penetration: The company aims to generate and publish new clinical data to support market penetration in the liver embolization market and other applications of the TriNav platform.
Operational Performance: The company is committed to improving operational performance in manufacturing and gross margins.
Cash and Liquidity: The company has sufficient liquidity to fund operations throughout 2025 and expects to become cash flow positive in early 2026.
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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