SI-BONE, Inc. (SIBN) SEC Filings & Earnings Calls

Continued Losses and Negative Cash Flow

“We have not achieved positive cash flow from operations for the six months ended June 30, 2026, and expect to incur additional losses in the future.” · word for word

Reimbursement Risk

“Our revenue is impacted by changes in average selling price as we respond to the competitive landscape and price differences at different medical facilities, such as hospitals, ASCs and OBLs.” · word for word

Net loss persists at $4.1M, though improving; path to sustained profitability not yet achieved.

“Net loss of $4.1 million” · word for word

Gross margin slightly declined from 79.8% to 79.5%, indicating potential cost pressure.

“Gross margin 79.5% vs 79.8%”

Dependence on new product launches and regulatory approvals for future growth; 510(k) submission not yet cleared.

“submitted 510(k) application for the third-breakthrough device” · word for word

Accumulated deficit and ongoing losses

“As of March 31, 2026, we had an accumulated deficit of $454.6 million ... expect to incur additional losses in the future.” · word for word

Dependence on debt financing

“We have $35.6 million in outstanding debt with floating interest rate (WSJ prime minus 0.5%, floor 4.25%).”

Seasonality and quarterly variability

“Our business is affected by seasonal variations. For instance, we have historically experienced lower sales in the summer months and higher sales in the last quarter of the fiscal year.” · word for word

Dependence on CMS finalization of proposed MS-DRG for iFuse Bedrock Granite

“CMS proposes, in their FY2027 IPPS Proposed Rule, the creation of a new MS-DRG family with higher payment for hospitals supporting complex spinal fusion procedures that incorporate iFuse Bedrock Granite” · word for word

Operating expenses growing with new product rollouts and commercial activity

“Operating expenses increased 4.1% to $47.0 million in the first quarter 2026, as compared to $45.2 million in the corresponding period in 2025.” · word for word

Reimbursement dependency

“Granted New Technology Add-On Payment effective October 1, 2025, providing incremental reimbursement to hospitals for eligible inpatient procedures using iFuse TORQ TNT.” · word for word

Competitive pressure

“Generic risk factor language present, but no specific current competitive threat quantified.”

Reimbursement uncertainty for CPT Code 27278

“In 2024, three Medicare Administrative Contractors finalized Local Coverage Determinations precluding coverage for CPT Code 27278.” · word for word

Single-source supplier dependency

“We generally use a small number of suppliers for our instruments and currently rely on RMS for iFuse 3D and iFuse TORQ implants and for several of the components, including the assembly and packaging, of our iFuse Bedrock Granite implants.” · word for word

Tariff exposure on Canadian titanium

“much of the titanium used in our implants is sourced from Canada and any disruption to trade with Canada caused by tariffs could increase the cost or disrupt the supply of our implants, which could materially harm our business, financial condition and results of operation.” · word for word

Continued operating losses

“For the years ended December 31, 2025, 2024, and 2023 we had net losses of $18.9 million, $30.9 million, and $43.3 million, respectively. As of December 31, 2025, we had an accumulated deficit of $450.3 million.” · word for word

Intense competition from larger medical device companies

“Some of our current and potential competitors are major medical device companies that have substantially greater financial, technical, and marketing resources than we do, and they may succeed in developing products that would render our products obsolete or noncompetitive.” · word for word

Tariff and trade retaliation risk could impact elective procedure demand.

“Impact of any future economic weakness or deterioration in economic conditions as a result of tariffs and retaliation by U.S. trading partners on the ability and desire of patients to undergo elective procedures.” · word for word

Supply chain risks may affect product availability.

“SI-BONE’s ability to manage risks to its supply chain.” · word for word

Capital requirements for new surgical systems could pressure liquidity.

“Future capital requirements driven by new surgical systems requiring instrument tray and implant inventory investment.” · word for word

Reimbursement changes could impact procedure adoption.

“SI-BONE’s ability to maintain favorable reimbursement for procedures using its products.” · word for word

Operating expenses increasing 11.9% YoY; reliance on U.S. market for majority of revenue.

“Operating expenses increased 11.9% to $44.2M; U.S. revenue represents 95% of total.” · word for word

Accumulated deficit and ongoing losses

“As of September 30, 2025, we had an accumulated deficit of $448.6 million as compared to $431.4 million as of December 31, 2024. During the nine months ended September 30, 2025, we incurred a net loss of $17.3 million.” · word for word

Dependence on debt financing

“As of both September 30, 2025 and December 31, 2024, we had $35.5 million in outstanding debt.” · word for word