Financial Data and Key Metrics Changes - Worldwide revenue reached $48.7 million in Q3 2025, representing approximately 21% growth year-over-year [4][19] - U.S. revenue grew over 21% to $46.4 million, driven by a procedure volume growth of over 22% [4][19] - Positive adjusted EBITDA of $2.3 million for the quarter, translating to an adjusted EBITDA margin of approximately 5% [6][22] - Gross profit was $38.8 million, an increase of 21.8% year-over-year, with a gross margin of 79.8% [20][21] Business Line Data and Key Metrics Changes - The launch of iFuse TORQUE contributed to notable international revenue growth, with international revenue at $2.3 million, representing 10.2% growth [19] - Double-digit volume growth was observed across all modalities, with a record number of physicians added in the quarter [5][6] - The number of physicians performing procedures using the company's solutions increased by 27% year-over-year, with 1,530 active physicians [14][70] Market Data and Key Metrics Changes - The company anticipates that the finalized 17% increase in reimbursement for office-based SI joint procedures will benefit its interventional business [8] - The new technology add-on payment (NTAP) of over $4,100 represents up to a 30% increase in hospital reimbursement for pelvic fracture fixation in Medicare patients [12][88] Company Strategy and Development Direction - The company is focused on innovation, physician engagement, commercial execution, and operational excellence as key priorities [7][17] - Plans to launch new products in 2026, including a next-generation technology aimed at optimizing physician workflow [9][11] - The company aims to expand its addressable market by developing solutions for compromised bone, leveraging its expertise in sacro-pelvic anatomy [14][76] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in sustaining strong top-line growth and expanding margins, driven by substantial adoption of current products and a promising pipeline [25][41] - The company is optimistic about achieving positive free cash flow in 2026, supported by improved profitability and cash flow from operating activities [23][46] Other Important Information - The company achieved its second consecutive quarter of net cash flow breakeven, ending the quarter with $145.7 million in cash and marketable securities [22][23] - The company has a significant pipeline of novel technologies under development, with expectations to launch several solutions over the next five years [14][78] Q&A Session Summary Question: Discussion on physician density and operating leverage - Management highlighted the importance of physician density and the opportunity to increase procedure types among existing surgeons, with a focus on leveraging the expanded product platform [29][30][32] Question: Guidance update and momentum in Q4 - Management raised the full-year revenue guidance to $198 million-$200 million, citing strong performance and physician growth trends as indicators of continued momentum [38][42][44] Question: Cash burn expectations for the rest of the year - Management indicated expectations of some cash usage in Q4 due to investments in surgical capacity and new product preparations, but expressed confidence in achieving free cash flow in 2026 [46][47] Question: Trends in gross margins and ASP - Management noted that gross margins are expected to stabilize around 78%-78.5%, with ASP remaining stable despite some modest impacts from procedure mix [55][56] Question: TNT and NTAP adoption trends - Management expressed excitement about the NTAP's potential to drive TNT adoption, with ongoing interest from national distributors to expand access to the technology [88][90]

Financial Data and Key Metrics Changes - Worldwide revenue reached $48.7 million in Q3 2025, representing approximately 21% growth year-over-year [4][17] - U.S. revenue grew over 21% to $46.4 million, driven by increased adoption of solutions [4][17] - Positive adjusted EBITDA of $2.3 million for the quarter, translating to an adjusted EBITDA margin of approximately 5% [5][19] - Gross profit was $38.8 million, an increase of $6.9 million or 21.8%, with a gross margin of 79.8% [17][18] - Net loss narrowed to $4.6 million, or $0.11 per diluted share, compared to a net loss of $6.6 million, or $0.16 per diluted share [18][19] Business Line Data and Key Metrics Changes - The flagship solutions continue to perform well in a large, under-penetrated market, with double-digit volume growth across all modalities [5][6] - The interventional case volume doubled compared to Q3 2024, indicating strong adoption of clinically validated solutions [7] - The number of procedures using more than two Granite implants per case grew approximately 40% in the quarter [9] Market Data and Key Metrics Changes - International revenue in Q3 was $2.3 million, representing 10.2% growth, with expectations for acceleration in 2026 due to the launch of iFuse TORQUE [17][18] - The company added 330 physicians in the quarter, marking a 27% year-over-year increase in active physicians [12][48] Company Strategy and Development Direction - The company aims to expand its addressable market by adding new applications of technology and expertise, focusing on compromised bone [22][23] - Plans to launch several innovative solutions over the next five years to address poor bone quality [12][54] - The company is focused on operational excellence, with a disciplined pricing strategy and ongoing supply chain optimization initiatives [18][19] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in sustaining strong top-line growth, expanding margins, and achieving positive free cash flow in 2026 [22][34] - The company anticipates continued physician engagement and adoption trends, with a significant opportunity to increase procedure density [12][15] - Management highlighted the importance of favorable reimbursement changes and the potential for new product launches to drive growth [37][61] Other Important Information - The company achieved its second consecutive quarter of net cash flow breakeven, ending the quarter with $145.7 million in cash and marketable securities [20][21] - The company is actively pursuing regulatory clearance to commercialize additional products across several international markets [17][56] Q&A Session Summary Question: Discussion on physician density and operating leverage - Management emphasized the importance of physician density and the opportunity to grow by increasing the use of technology across different procedure types [24][25] - Operating leverage is expected to range between 1.25-1.75 times, with a focus on delivering strong top-line growth [27][28] Question: Guidance update and momentum in Q4 - Management raised the full-year revenue guidance to $198 million-$200 million, reflecting continued outperformance and strong momentum heading into Q4 [30][32] Question: Trends in cash burn expectations - Management expects to use some cash in Q4 for building surgical capacity but remains confident in achieving free cash flow in 2026 [34] Question: Insights on TNT and NTAP adoption - Management expressed excitement about the NTAP, which represents a significant reimbursement improvement, and noted strong interest from national distributors for TNT [57][59] Question: Long-term profitability and operating leverage - Management highlighted the unique business model that allows for high ASP and operating leverage, with expectations for margin expansion as new products contribute to revenue [61][62]

Financial Performance - Revenue for Q3 2025 reached $48.656 million, a 20.5% increase from $40.340 million in Q3 2024[17] - Gross profit for Q3 2025 was $38.846 million, compared to $31.903 million in Q3 2024, reflecting a gross margin improvement[17] - Operating expenses increased to $44.229 million in Q3 2025 from $39.536 million in Q3 2024, primarily driven by higher sales and marketing costs[17] - Net loss for Q3 2025 was $4.566 million, an improvement from a net loss of $6.575 million in Q3 2024[17] - Revenue for the three months ended September 30, 2025, was $48,656, an increase from $40,340 in the same period of 2024, representing a growth of 8.1%[34] - For the nine months ended September 30, 2025, the net loss was $17,260, compared to a net loss of $26,418 for the same period in 2024[25] - For the three months ended September 30, 2025, the net loss was $4,566,000, compared to a net loss of $6,575,000 for the same period in 2024, representing a 30.6% improvement[80] - The basic and diluted net loss per share for the three months ended September 30, 2025, was $(0.11), an improvement from $(0.16) in the same period of 2024[80] - For the nine months ended September 30, 2025, the net loss was $17,260,000, down from $26,418,000 in the same period of 2024, indicating a 34.7% reduction[80] - The basic and diluted net loss per share for the nine months ended September 30, 2025, was $(0.40), compared to $(0.64) for the same period in 2024[80] Assets and Liabilities - Total current assets as of September 30, 2025, were $210.784 million, up from $207.779 million at the end of 2024[16] - Total liabilities decreased to $62.147 million as of September 30, 2025, compared to $63.473 million at the end of 2024[16] - Stockholders' equity increased to $172.126 million as of September 30, 2025, from $166.964 million at the end of 2024[16] - As of September 30, 2024, the total stockholders' equity was $164,974, with a net loss of $6,575 for the quarter[22] - The company reported cash and cash equivalents of $26,487 as of September 30, 2025, down from $30,225 at the end of the same period in 2024[25] - As of September 30, 2025, total marketable securities amounted to $140.660 million, with unrealized gains of $75, and unrealized losses of $2[42] - The allowance for credit losses increased to $985,000 as of September 30, 2025, from $588,000 at the end of 2024, with write-offs of $140,000 during the period[51] - The company reported accrued liabilities of $17.587 million as of September 30, 2025, a decrease from $19.492 million as of December 31, 2024[50] - The company had purchase commitments related to inventory management amounting to $3.5 million as of September 30, 2025, up from $0.4 million at the end of 2024[56] Inventory and Expenses - The company experienced a decrease in inventory of $10,334 for the nine months ended September 30, 2025, compared to a decrease of $5,922 in 2024[25] - Inventory as of September 30, 2025, consisted of finished goods valued at $31.2 million and work-in-progress and components valued at $4.5 million, compared to $24.0 million and $3.1 million respectively as of December 31, 2024[48] - Depreciation expense for the three months ended September 30, 2025, was $1.5 million, compared to $1.1 million for the same period in 2024[49] - Stock-based compensation for the nine months ended September 30, 2025, was $19,547, slightly down from $19,734 in 2024[25] - Stock-based compensation expense for the three months ended September 30, 2025 totaled $6.226 million, slightly down from $6.306 million in the same period of 2024[78] Future Outlook and Strategy - The company expects to derive a significant portion of revenue from products addressing sacropelvic anatomy in the future[12] - The company is focused on developing additional revenue opportunities, including new indications for use and new products[12] - The company anticipates challenges related to supply chain factors, including tariffs and availability of raw materials[12] - The company launched new products including iFuse INTRA and iFuse TORQ TNT in 2024, expanding its product line for sacroiliac joint treatment[27] - International revenue accounted for less than 10% of total revenue during the periods presented, indicating a strong reliance on the U.S. market[34] Debt and Financing - As of September 30, 2025, the outstanding principal of the term loan is $36.0 million, with net outstanding debt of $35.540 million after deducting unamortized debt issuance costs[62] - The effective interest rate for the three and nine months ended September 30, 2025 was 7.3%, down from 9.2% and 9.3% for the same periods in 2024[69] - The future principal payments under the Fourth Amended Loan Agreement total $36.0 million, with $6.0 million due in 2027, $18.0 million in 2028, and $12.0 million in 2029[69] - The Company has a secured revolving credit facility of up to $15.0 million as part of its financing arrangements[64] - The Third Amendment to the Loan and Security Agreement sets the maturity date for the term loan as September 1, 2029, with the first principal repayment due on October 1, 2027[66] - The Company was in compliance with all debt covenants as of September 30, 2025[69] Compliance and Risks - The company is cooperating with an investigation by the U.S. Department of Justice regarding compliance with the federal Anti-Kickback Statute, which may have a material impact on its financial condition[60] - The company has foreign currency risks primarily related to revenue and operating expenses denominated in currencies other than the U.S. dollar, particularly the Euro[156] - A hypothetical 100 basis point change in foreign exchange rates during the periods presented would not have had a material impact on the condensed consolidated financial statements[157] - The company’s exposure to interest rate risk is considered low, with a floating annual interest rate on the Third Amendment Term Loan set at the greater of the prime rate minus 0.5% or 4.25%[159] - The company has not entered into derivatives or other financial instruments to hedge foreign currency exchange risk but may consider this in the future[157] Employee Stock Purchase Plan - The total accumulated employee payroll deductions related to the Employee Stock Purchase Plan (ESPP) amounted to $0.6 million as of September 30, 2025[76] - Proceeds from the issuance of common stock under the employee stock purchase plan were $1,568 for the nine months ended September 30, 2025, compared to $1,472 in 2024[25] - The Company granted 1,305,384 Restricted Stock Units (RSUs) with an average grant date fair value of $16.79 during the nine months ended September 30, 2025[74] - As of September 30, 2025, there are 910,018 stock options outstanding with a weighted average exercise price of $11.41[70]

The statements in this presentation regarding expectations of future events or results, including SI-BONE's expectations of continued revenue and procedure growth and financial outlook, are "forward-looking" statements. These forward-looking statements are based on SI-BONE's current expectations and inherently involve significant risks and uncertainties. These risks include SI-BONE's ability to introduce and commercialize new products and indications, SI-BONE's ability to maintain favorable reimbursement fo ...

Revenue Growth - Worldwide revenue for Q3 2025 was $48.7 million, a 20.6% increase from $40.3 million in Q3 2024[7] - U.S. revenue for Q3 2025 was $46.4 million, reflecting a 21.2% growth from $38.3 million in Q3 2024[7] - The company expects 2025 worldwide revenue to be in the range of $198 million to $200 million, implying year-over-year growth of approximately 18% to 20%[12] Profitability Metrics - Gross margin improved to 79.8% in Q3 2025, up from 79.1% in Q3 2024, representing an improvement of 75 basis points[8] - Adjusted EBITDA was positive at $2.3 million in Q3 2025, compared to an adjusted EBITDA loss of $0.2 million in Q3 2024[10] - Net loss improved by 30.6% to $4.6 million, or $0.11 per diluted share, in Q3 2025, compared to a net loss of $6.6 million, or $0.16 per diluted share, in Q3 2024[10] Operational Highlights - The number of active U.S. physicians increased by 27% to 1,530 in Q3 2025[6] - New Technology Add-on Payment (NTAP) for procedures involving iFuse TORQ TNT is over $4,100 effective October 1, 2025[6] - Operating expenses increased by 11.9% to $44.2 million in Q3 2025, driven by higher revenue and new product rollout[9] Cash Position - Cash and equivalents as of September 30, 2025, were $145.7 million, compared to $145.5 million as of June 30, 2025[11]

Core Insights - SI-BONE, Inc. reported a strong financial performance in Q3 2025, with worldwide revenue growth of approximately 21% and a positive adjusted EBITDA margin of $2.3 million, indicating robust demand for its medical devices [1][7][8]. Financial Performance - Worldwide revenue reached $48.7 million, a 20.6% increase from $40.3 million in Q3 2024 [4][8]. - U.S. revenue was $46.4 million, reflecting a 21.2% increase from $38.3 million in the same period last year, driven by strong procedure demand [4][8]. - International revenue was $2.3 million, a 10.2% increase from $2.1 million in Q3 2024, attributed to the successful launch of the TORQ product in European markets [4][8]. Profitability Metrics - Gross profit for the quarter was $38.8 million, up 21.8% from $31.9 million in Q3 2024, with a gross margin of 79.8%, an improvement of 75 basis points year-over-year [5][8]. - Operating expenses increased by 11.9% to $44.2 million, primarily due to higher commercial activities and new product rollouts [6][8]. - The operating loss improved by 29.5% to $5.4 million compared to a loss of $7.6 million in Q3 2024 [6][8]. Net Loss and Cash Flow - The net loss for the quarter was $4.6 million, or $0.11 per diluted share, an improvement of 30.6% from a net loss of $6.6 million, or $0.16 per diluted share, in Q3 2024 [7][8]. - Positive cash from operating activities was reported at $2.3 million, indicating effective cash management [8]. Guidance and Future Outlook - For fiscal 2025, SI-BONE expects worldwide revenue to be between $198 million and $200 million, representing year-over-year growth of approximately 18% to 20% [10][11]. - The company anticipates a gross margin of around 79.5% for the full year 2025, reflecting continued operational efficiency [10][11]. Operational Highlights - The number of active U.S. physicians increased by 27% to 1,530, indicating growing adoption of SI-BONE's technologies [8]. - The trailing 12-month average revenue per territory rose by 16% to $2.1 million, showcasing improved sales performance [8].

Core Insights - SI-BONE, Inc. will report its financial results for Q3 2025 on November 10, 2025, after market close [1] - A conference call will be held at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time to discuss the results [1] Company Overview - SI-BONE is a global leader in developing technologies for surgical treatment of sacropelvic disorders, having pioneered minimally invasive SI joint surgery in 2009 with the iFuse Implant System [3] - The company has supported over 4,600 physicians in performing nearly 130,000 procedures, backed by over 175 peer-reviewed publications, including four randomized controlled trials [3] - SI-BONE has expanded its offerings to adjacent markets, including adult deformity, spinopelvic and sacropelvic fixation, and pelvic trauma [3]

Core Points - SI-Bone, Inc. experienced a data breach on or about October 1, 2025, which has led to an investigation into data privacy claims [1][3] - The breach may have exposed sensitive personal information, including names, Social Security numbers, driver's license numbers, addresses, medical information, and health insurance information [3] - Edelson Lechtzin LLP is investigating a potential class action lawsuit for individuals whose sensitive personal data may have been compromised [4] Company Overview - SI-Bone, Inc. is based in Santa Clara, California, and specializes in developing minimally invasive devices for treating sacropelvic conditions, particularly SI joint pain [2] Legal Context - Edelson Lechtzin LLP is a national class action law firm that focuses on various litigation areas, including data breaches, securities fraud, antitrust violations, and consumer fraud [5]

Group 1 - The company has evolved from focusing solely on the sacropelvic joint space to becoming a broader platform in the medical industry [1][2] - The company was established with a specific focus on the sacroiliac (SI) joint, which is the largest joint in the human body and previously lacked a surgical solution [2][3] - The CEO has been with the company for over 10 years, starting as CFO in 2015, indicating a strong leadership continuity [2]

Group 1 - The company has evolved from focusing solely on the sacropelvic joint space to becoming a broader platform in the medical field [1][2] - The company was initially established to address the lack of surgical solutions for the sacroiliac (SI) joint, which is the largest joint in the human body [2][3] - The CEO has been with the company for over 10 years, starting as CFO in 2015, indicating a strong leadership continuity [2]