SiBone Q3 Earnings Call Highlights

Key Points

• SiBone’s Q3 revenue rose 14.5% to $55.7 million, driven by a 19.5% increase in U.S. procedure volume and 16% growth in active physicians to approximately 1,770. International revenue increased 27% to $2.9 million.
• The company began an alpha launch of its newly FDA-cleared iFuse Granite Onyx platform in October, targeting roughly 200,000 annual U.S. procedures and a $1.5 billion market opportunity. A full launch is planned for January, with potential reimbursement support under review.
• Profitability improved as adjusted EBITDA increased 32.4% to $3 million and the net loss narrowed to $3.6 million. SiBone reaffirmed 2026 revenue guidance of $231 million to $233 million while lowering its expected operating-expense growth rate to 10.5%.

SiBone NASDAQ: SIBN reported third-quarter 2026 revenue growth of 14.5% as procedure demand accelerated, active physician adoption expanded and profitability improved. The company said it is building on momentum across its sacroiliac joint, complex spinal fusion and trauma offerings, while preparing for a broader launch of its newly cleared iFuse Granite Onyx platform.

Worldwide revenue totaled $55.7 million for the quarter ended Sept. 30, including U.S. revenue of $52.8 million, up 13.9% year over year. International revenue rose 27% to $2.9 million, driven by growing procedure volume for the TORQ and TNT technologies.

U.S. procedure volume increased 19.5%, while the number of active physicians grew 16% to approximately 1,770. Chief Executive Officer Laura Francis said demand grew across procedure types and reflected the company’s effort to diversify physician call points and sites of care.

Procedure Growth Outpaced Revenue as Mix Affected ASP

Chief Operating Officer and Chief Financial Officer Anshul Maheshwari said U.S. revenue growth lagged procedure-volume growth partly because of lower average selling prices. The change reflected procedure mix, including the number of implants used per case, as well as a higher share of procedures performed in ambulatory surgery centers and office settings.

SiBone said adoption of its INTRA platform by interventional spine physicians was a significant contributor to procedure growth. These procedures are often performed in ASC and office-based settings, which typically carry lower selling prices than other settings.

Francis said INTRA has gained a leading position among interventional physicians for SI joint fusion, supported by the company’s portfolio, clinical evidence and training programs. She added that surgeons still accounted for the majority of procedures during the quarter.

The company also cited progress in trauma through its collaboration with Smith+Nephew, focused on awareness and education for treating sacral insufficiency fractures using iFuse TORQ TNT. Francis said the companies’ joint commercial efforts were beginning to show results entering the seasonally stronger trauma period.

Onyx Alpha Launch Begins Following FDA Clearance

SiBone received FDA 510(k) clearance for iFuse Granite Onyx in September and began an alpha launch in October. The product is intended to address screw loosening at the upper and lower ends of spinal fusion constructs, particularly in patients with compromised bone quality.

Francis called Onyx one of the company’s most significant launches and said early demand was tracking ahead of Granite during the comparable launch period. The company expects only a modest fourth-quarter revenue contribution from the platform before moving to a full launch in January.

Management said early users have deployed Onyx in procedures alongside Granite, as well as in cases that do not extend to the pelvis and therefore may not use Granite. The company also said some physicians who have not previously used Granite have expressed interest in Onyx.

“The most obvious application is for our surgeons to use Onyx in the same cases as Granite, and we're seeing that come through,” Francis said during the question-and-answer session. In cases using both products, she said the company has seen utilization of roughly six implants per procedure.

SiBone estimates that Onyx targets approximately 200,000 annual U.S. procedures and represents a $1.5 billion market opportunity. Together with Granite, the company estimates its complex fusion market opportunity at about $2.5 billion. Overall, management said the addition of Onyx raises its estimated total addressable market to more than 650,000 procedures, or approximately $5 billion annually.

The company has submitted an application to the Centers for Medicare & Medicaid Services for a new technology add-on payment, or NTAP, for Onyx. If approved, the payment would take effect Oct. 1, 2027. SiBone said it also plans to launch a prospective multicenter clinical study evaluating Onyx safety and clinical performance, while leveraging existing bench and animal studies.

Reimbursement Developments Could Support Granite and Onyx

New diagnosis-related groups for multilevel spinal fusion procedures incorporating pelvic fixation with Granite took effect Oct. 1. Francis said the new DRGs could raise average hospital payment by as much as $50,000 for qualifying procedures, depending on diagnosis and severity.

The company said the new reimbursement framework applies across payers, unlike Granite’s prior NTAP, which was limited to Medicare cases and expired in October 2025. Management said Onyx may benefit when used with Granite in qualifying long spinal fusion procedures.

SiBone is also awaiting a final CMS ruling on proposed reimbursement changes for SI joint procedures. Under the proposal described by management, hospital outpatient payments would rise to more than $20,000, ASC payments would exceed $16,000, and office payments of $20,000 per CPT 27279 would be established. If finalized, those changes would take effect Jan. 1, 2027.

Profitability, Cash Flow and Outlook

Gross profit increased 13.7% to $44.2 million, while gross margin was 79.3%, ahead of the company’s guidance. Operating expenses rose 9.7%, below revenue growth, as higher commissions, product marketing and research and development investment were partially offset by operating leverage.

Net loss narrowed to $3.6 million, or $0.08 per diluted share, from $4.6 million, or $0.11 per diluted share, a year earlier. Adjusted EBITDA rose 32.4% to $3 million, representing a 5.5% margin.

SiBone ended the quarter with $146.3 million in cash and equivalents, up about $400,000 sequentially. Year-to-date operating cash flow was approximately $4.4 million, compared with $2.4 million of cash used in the prior-year period.

The company reaffirmed its 2026 worldwide revenue guidance of $231 million to $233 million and its gross-margin expectation of 79%. It reduced its projected operating-expense growth rate to 10.5% from a previous expectation of 12% while continuing to invest in the Onyx launch and R&D programs.

At the midpoint, SiBone’s full-year revenue outlook implies more than 20% year-over-year growth in the fourth quarter. Maheshwari said management expects fourth-quarter momentum to be supported by physician growth, interventional adoption, trauma activity, broader commercial capacity and a modest contribution from new products.

Looking beyond 2026, management said it expects some modest gross-margin pressure from added Onyx surgical capacity and associated non-cash depreciation costs. However, Maheshwari said the company expects continued operating leverage as revenue grows and remains focused on investments in sales capacity, clinical programs, manufacturing capabilities and future product launches.

About SiBone (NASDAQ:SIBN)

SI-BONE, Inc NASDAQ: SIBN is a medical device company focused on diagnosing and treating disorders of the sacroiliac joint, which connects the spine to the pelvis. The company develops minimally invasive surgical solutions intended to stabilize the sacroiliac joint and address sacroiliac joint dysfunction and related conditions.

Its product portfolio is centered on the iFuse Implant System, a family of triangular implants designed to be placed across the sacroiliac joint. SI-BONE also offers products such as iFuse-TORQ, a threaded implant system, and iFuse Bedrock Granite, which is designed for sacroiliac joint fusion and pelvic fixation as part of certain spinal procedures.

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