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The company raised its guidance midpoint due to strong Q3 performance and expects continued positive momentum in Q4. They achieved positive cash flow from operating activities and have a strong product pipeline with international growth prospects. Gross margins exceeded expectations, and they anticipate further improvement. Despite some vague responses, the overall sentiment from the Q&A is positive, with strong growth drivers and strategic initiatives in place.
Worldwide Revenue $48.7 million in the third quarter, representing approximately 21% growth year-over-year. This growth was driven by healthy demand trends, disciplined execution, and the launch of iFuse-TORQ in Europe.
U.S. Revenue $46.4 million, representing 21.2% growth year-over-year. This was driven by growing adoption of solutions and procedure volume growth of over 22%.
International Revenue $2.3 million, representing 10.2% growth year-over-year. Growth was fueled by the launch of iFuse-TORQ and increasing adoption trends.
Gross Profit $38.8 million, an increase of $6.9 million or 21.8% year-over-year. Gross margin expanded by 75 basis points to 79.8%, driven by disciplined pricing strategy and supply chain optimization.
Operating Expenses $44.2 million, an increase of $4.7 million or 11.9% year-over-year. The increase reflects growth-related investments, higher commissions from increased revenue, and elevated G&A spending.
Net Loss $4.6 million, narrowed from $6.6 million year-over-year. This improvement reflects better operational efficiency and revenue growth.
Adjusted EBITDA $2.3 million, translating to an adjusted EBITDA margin of approximately 5%. This is a significant improvement from an adjusted EBITDA loss of $11.7 million in the prior year period.
Cash from Operating Activities $2.3 million, marking the first quarter of meaningful positive cash flow from operating activities. This milestone reflects increasing scale and an asset-light business model.
iFuse-TORQ commercialization in Europe: Successfully launched iFuse-TORQ in Europe, contributing to international revenue growth.
New products for 2026: Significant progress on two new products expected to launch in 2026.
Granite 9.5: Expanding into the degenerative spine procedure market with Granite 9.5, targeting nearly 100,000 annual procedures.
iFuse-TORQ TNT: Breakthrough technology for sacral insufficiency fractures, a $300 million market opportunity, with strong clinical reception and distributor interest.
Third breakthrough device: Incorporates engineering and biomechanical learnings, expected to commercialize by late 2026.
U.S. revenue growth: Revenue grew over 21% to $46.4 million, driven by growing adoption of solutions.
International revenue growth: International revenue grew by 10.2%, with expectations for acceleration in 2026 due to iFuse-TORQ.
Physician engagement: Added 330 physicians in Q3 2025, marking the largest quarterly increase in company history.
Revenue growth: Worldwide revenue reached $48.7 million, a 20.6% increase.
Profitability: Achieved positive adjusted EBITDA of $2.3 million, with a margin of approximately 5%.
Cash flow: Generated $2.3 million in cash from operating activities, achieving positive operating cash flow for the first time.
Innovation focus: Focused on improving surgical outcomes for patients with compromised bone and expanding the application of existing technologies.
Reimbursement improvements: CMS finalized a 17% increase in reimbursement for office-based SI joint procedures, benefiting interventional business.
Territory expansion: Plan to increase the number of territories to capitalize on market opportunities.
Regulatory Approvals: The company is actively pursuing regulatory clearance to commercialize additional products across several international markets, which could delay international growth if not achieved as planned.
Reimbursement Changes: Proposed reimbursement changes, such as the transitional pass-through payment for Granite and the NTAP for TNT, are critical for the company's financial performance. Any unfavorable changes could negatively impact revenue.
Supply Chain Costs: Higher instrument depreciation and freight costs were noted, which could pressure gross margins if not managed effectively.
Market Penetration: The company is expanding into underpenetrated markets, but success depends on physician adoption and market acceptance of new products.
Product Launch Timelines: Delays in FDA approvals or product launches, such as the next-generation technology expected in 2026, could impact revenue growth and market positioning.
Economic Conditions: Broader economic uncertainties could affect hospital budgets and physician adoption rates, impacting the company's revenue.
Operational Expenses: Increased operating expenses, including growth-related investments and higher commissions, could strain profitability if revenue growth slows.
Revenue Guidance for 2025: Updated full-year revenue guidance to range between $198 million to $200 million, implying year-over-year growth of approximately 18% to 20%.
Gross Margin Expectation: Full-year gross margin expected to be at 79.5%.
Operating Expense Growth: Annual operating expense growth guidance maintained at 10% at the midpoint of the revenue range.
Free Cash Flow in 2026: Company expects to achieve positive free cash flow in 2026.
International Growth in 2026: Anticipates acceleration in international growth in 2026 driven by physician enthusiasm and adoption trends of iFuse-TORQ.
Regulatory Clearances for International Markets: Actively pursuing regulatory clearance to commercialize additional products across several international markets, expected to impact growth meaningfully in 2027 and beyond.
New Product Launches in 2026: Plans to launch two new products in 2026, including a next-generation technology optimized for ambulatory surgery centers in Q1 2026 and a third breakthrough device by late 2026.
Granite Product Reimbursement in 2026: Proposed reimbursement changes may benefit Granite in 2026, including the extension of transitional pass-through payment and a proposed Level 7 APC payment of nearly $28,000 for outpatient procedures.
TNT Technology Growth Potential: TNT technology expected to contribute significantly to growth over the next several years, supported by a new technology add-on payment (NTAP) of more than $4,100 and growing distributor network.
Pipeline of Novel Technologies: Extensive pipeline of novel technologies under development, with several solutions expected to launch over the next 5 years to address poor bone quality.
The selected topic was not discussed during the call.
The company raised its guidance midpoint due to strong Q3 performance and expects continued positive momentum in Q4. They achieved positive cash flow from operating activities and have a strong product pipeline with international growth prospects. Gross margins exceeded expectations, and they anticipate further improvement. Despite some vague responses, the overall sentiment from the Q&A is positive, with strong growth drivers and strategic initiatives in place.
The earnings call summary indicates strong financial performance with 25% revenue growth and positive guidance for 2025. The Q&A session highlighted expansion opportunities, strong product adoption, and reimbursement tailwinds, despite some uncertainties in gross margin stabilization. The company's strategic focus on market expansion and new product launches, along with positive adjusted EBITDA expectations, further supports a positive sentiment. These factors, combined with the absence of negative catalysts like margin decline or guidance refusal, suggest a likely stock price increase in the short term.
The earnings call summary reflects strong financial performance with 25% revenue growth and improved margins. The guidance is optimistic with expectations of positive adjusted EBITDA in 2025. The Q&A session highlights broad-based growth and strong product adoption, despite management's cautious stance on long-term guidance. No major risks were identified, and the absence of a share repurchase program is a minor negative. Overall, the company's strong growth, margin improvements, and optimistic guidance suggest a positive stock price movement.
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