📄 What This Document Is 🔎

This document is SI-BONE, Inc.'s Annual Report on Form 10-K. Think of this as the definitive year-end report card that the company provides to its investors and the public. It summarizes the company’s performance, its financial health, and its major risks over the fiscal year ending December 31, 2025. You should expect a comprehensive deep dive into how SI-BONE operates, the market landscape, and all the potential pitfalls and regulatory hurdles the company faces.

👉 Why it matters: Reading this report is critical because it shows the historical facts (the numbers) but, more importantly, it warns investors about the future risks that could severely affect the company's success.

🏢 What SI-BONE Does 🔩

SI-BONE, Inc. is a medical device company that specializes in treatments for the sacroiliac joint—the joint connecting the pelvis to the lower spine. The company's core business is pioneering anatomy-specific solutions for sacroiliac joint fusion and fixation. They sell implants and instruments used by surgeons, helping patients with chronic lower back pain.

👉 In simple terms: They manufacture highly specialized hardware (implants) that surgeons place into the sacroiliac joint to stabilize and fuse the area, treating chronic lower back pain.

💰 2025 Financial Performance Highlights ✨

The filing provides a snapshot of SI-BONE’s financial performance for 2025, showcasing both significant revenue growth and continued investments in growth. Overall, the company is highly focused on market expansion and continuing to build its infrastructure.

• Worldwide Revenue: SI-BONE achieved worldwide revenue of $200.9 million. This represents an annual increase of approximately 20%, demonstrating strong market adoption of their products.
• Adjusted EBITDA: The company delivered positive Adjusted EBITDA of $8.9 million. This is a major improvement compared to the $5.1 million loss recorded in 2024, suggesting the core business operations are generating significant operational cash flow.
• Net Loss: SI-BONE recorded a net loss of $18.9 million. However, this loss represents an annual improvement of approximately 39% compared to previous years, indicating that revenue growth is significantly outpacing operating expenses.
• Balance Sheet Strength: As of December 31, 2025, the company ended the year with a strong balance sheet, reporting $147.8 million in cash and equivalents. This cash reserve provides a significant cushion for ongoing R&D and market expansion.

🚀 Key Operational Milestones & Growth ⚙️

The company reported several key achievements in 2025 that point to both market scale and specialized operational success. These metrics help visualize the actual size of their market footprint.

• Procedure Volume: Over 2,400 U.S. physicians performed nearly 22,000 procedures during 2025.
• Total Procedures: Since the company's inception, over 140,000 procedures have been performed globally, demonstrating cumulative trust and adoption of their technology.
• Product Launch (Europe): SI-BONE launched iFuse TORQ across Europe. This expansion into a major international market is a significant step in global growth.
• Reimbursement Advantage: The company successfully granted a New Technology Add-On Payment effective October 1, 2025. This payment provides extra reimbursement to hospitals for eligible inpatient procedures using the iFuse TORQ TNT product, which directly increases revenue potential.

🎯 Sales and Market Positioning 🧑‍⚕️

SI-BONE relies heavily on its network of doctors and sales representatives to grow. The company maintains a structured and growing sales infrastructure both domestically and internationally.

• Target Customer Base: As of December 31, 2025, the target customer base includes over 12,000 U.S. physicians, which comprises nearly 7,500 orthopedic and neurological surgeons and approximately 4,500 interventional spine physicians.
• U.S. Sales Force (Dec 31, 2025): The U.S. team consisted of 89 territory sales managers, 83 clinical specialists, and 320 third-party sales agents.
• International Sales Force (Dec 31, 2025): The global team included 11 direct sales representatives and 28 third-party sales agents, collectively providing sales in 38 countries.

🔬 Research, Development, and Training 🎓

To maintain its market leadership, SI-BONE emphasizes innovation and physician education. The company views ongoing training as essential for supporting revenue growth.

• Technology Leadership: The company asserts it is an industry leader, noting that three of its platform technologies were designated as breakthrough devices by the FDA.
• Product Pipeline: The development team has a pipeline of products in various stages, which helps ensure the company can meet the evolving needs of its physician customers.
• Training Methods: SI-BONE uses specialized continuing education programs worldwide and introduced the SI-BONE Simulator. This portable training simulator provides realistic haptic feedback, allowing physicians to practice procedures without needing an operating room.

🌎 International and Product IP Protection 🛡️

Protecting its intellectual property and ensuring global regulatory compliance are massive undertakings. SI-BONE highlights its extensive global patent and trademark portfolio.

• Patent Portfolio (Dec 31, 2025): SI-BONE owned 49 issued U.S. patents and had 24 pending U.S. patent applications, alongside 23 issued foreign patents and 23 pending foreign patent applications.
• Patent Expiration Dates: Key product patents have long lifespans, including:
  • iFuse triangular shape: expected to expire by August 2028.
  • iFuse 3D (fenestrated design): expected to expire in September 2035.
  • iFuse TORQ: expected to expire in February 2041.
• Trademarks: The company holds 24 registered trademarks in the U.S. and has registrations in 58 countries, including all 27 European Union member countries.

⚖️ Market Access and Reimbursement Risks 💵

This is arguably the most complex and critical risk area for SI-BONE. The company's revenue is not just dependent on selling a product, but on the payers (like Medicare/private insurance) agreeing to pay for it. Any change in payment rules is a massive threat.

• CPT Coding Changes: The revenue stream relies on specific CPT Codes. As of January 1, 2026, Medicare physician fee for transarticular iFuse implants (Code 27279) was $762. However, reimbursement for non-piercing implants (Code 27278) is inconsistent, with three Medicare Administrative Contractors finalizing Local Coverage Determinations precluding coverage for that code in 2024.
• Office-Based vs. Facility Setting: For Code 27279, there is currently no corresponding value for office-based reimbursement. This means that even if the procedure happens in a physician's office, the reimbursement model may make it financially unviable for the company.
• Payor Uncertainty: The filing warns that many private payers have yet to set coverage decisions for CPT Code 27278, and the reimbursement environment for the transarticular implants is subject to constant scrutiny.

🌍 Global Regulatory Compliance Requirements ⚠️

SI-BONE operates under a web of global regulations, making compliance a major factor in their cost and timeline. The regulatory oversight is intense and complex.

• U.S. FDA Oversight: All products sold in the U.S. must navigate the FDA, requiring either 510(k) clearance (for lower risk devices, proving "substantial equivalence" to an existing product) or PMA (for higher-risk devices).
• Human Tissue Products: Since certain products are derived from human tissue (demineralized bone tissue), they are governed as 361 HCT/Ps, requiring stringent Good Tissue Practices.
• European Market: In the European Economic Area (EEA), compliance requires meeting the General Safety and Performance Requirements (GSPRs) of the Medical Device Regulation (MDR). This culminates in the ability to affix the CE mark after review by a designated Notified Body.
• Mandatory Reporting: The company must adhere to reporting rules for Adverse Events and is subject to unexpected inspections. Failure in compliance can lead to severe penalties, including warning letters, fines, and forced product recalls.

🚨 Legal & Fraud Risk Factors 🚨

The filing dedicates substantial space to the risks associated with federal and state laws concerning healthcare fraud. Compliance is not optional; it is a core, high-stakes operational necessity.

• Anti-Kickback and False Claims Acts: The company must comply with the federal Anti-Kickback Statute (which prohibits offering or receiving anything of value to influence referrals) and the False Claims Act (which prohibits submitting false claims for government payment).
• HIPAA & Privacy: The company processes sensitive patient data and must comply with the Health Insurance Portability and Accountability Act (HIPAA), requiring strict measures to protect the privacy and security of medical records.
• Anti-Bribery Laws: Global laws like the U.S. Foreign Corrupt Practices Act (FCPA) and the UK Bribery Act (UKBA) strictly prohibit making improper payments to foreign government officials or other persons to secure business.

🤝 Competition and Market Landscape 🥊

The medical device market for sacroiliac fusion is intensely competitive. While SI-BONE believes its comprehensive solutions provide a competitive edge, the threat from larger players is significant.

• Major Competitors: SI-BONE identifies key competitors including Alphatec Holding Inc., Aurora Spine Corporation, Globus Medical, Inc., Medtronic plc., and Tenon Medical, Inc.
• Competitive Advantage Claim: SI-BONE argues it has the most comprehensive set of solutions, supported by clinical evidence, and boasts the largest dedicated direct sales force focused on the sacropelvic segment.
• Industry Challenge: Larger competitors can afford to bundle products (like surgical imaging and robotics) into large purchasing arrangements, creating a barrier to entry that is difficult for smaller players like SI-BONE to overcome.

📅 Annual Meeting and Company Contact 📧

The company provided clear logistics for its shareholders to attend the annual meeting.

• Annual Meeting: The Annual Meeting of Stockholders is scheduled for Thursday, June 4, 2026, at 8:00 a.m. Pacific Time.
• Format: The meeting will be held virtually.
• Key Contact: The letter was signed by Laura Francis, Chief Executive Officer.
• Address: 471 El Camino Real, Suite 101 Santa Clara, California 95050.
• Phone: (408) 207-0700.

🧠 The Analogy

Think of SI-BONE as a boutique luxury car manufacturer that designs and builds incredibly complex, high-tech vehicles. Their genius is the engine (the implant technology), and they have patent protections that keep rivals out. However, the industry is like a massive global auto show (the medical market). Every corner of the show has major, deep-pocketed competitors (Medtronic, etc.) who can sell massive fleets of cars bundled together. Furthermore, before they can even sell a car, they must pass rigorous, constantly changing government safety inspections (FDA, MDR), and the insurance company (the payer) must agree not only to buy the car but also to pay for the service, or the whole operation grinds to a halt.

🧩 Final Takeaway

SI-BONE is a growing medical device company with strong early operational growth and a robust portfolio, but its future success is critically exposed to evolving government reimbursement codes, intensive global regulatory hurdles, and fierce competition from industry giants.