Ravi M.

Ravi, on behalf of Richard Newitter, questioned the rationale behind the 2026 guidance for high teens U.S. volume growth, which represents a step down from 2025, despite a focused sales force, the Smith+Nephew partnership, and new product launches. He also asked about the incremental profit margin for sales transferred to Smith+Nephew.

Answer

CFO and COO Anshul Maheshwari explained that the high teens volume growth guidance considers the tougher comparable from 2025, which benefited from late 2024 product launches. He emphasized prudence in early-year guidance before the full impact of new products, reimbursement, and commercial expansion materializes. Mr. Maheshwari declined to provide specific profit details for the Smith+Nephew relationship, highlighting its multifaceted impact, including national access in trauma sites, satisfying demand, and freeing up SI-BONE's direct sales force to build relationships with spine surgeons and interventionalists.

Ravi questioned the rationale for the 2026 guidance of high teens U.S. volume growth, which represents a step down from 2025, despite a focused sales force, the Smith+Nephew partnership, and new product launches. He also asked about the incremental or marginal profit for each dollar of sales transferred to Smith+Nephew through the partnership.

Answer

CFO Anshul Maheshwari attributed the high teens growth to a tougher comparable period in 2025, where Q1 and Q2 benefited from late 2024 product launches. He emphasized that SI-BONE is prudent in its guidance, allowing new products, reimbursement coverage, and commercial expansion impacts to materialize later in the year. Regarding the Smith+Nephew partnership, Anshul Maheshwari stated that SI-BONE would not disclose specific financial details, highlighting instead the multifaceted benefits, including national access to trauma sites, satisfying demand, and freeing up SI-BONE's direct sales force to build relationships with spine surgeons and interventionalists.

Ravi from Truist Securities, on behalf of Richard Newitter, sought clarity on the remediation timeline, asking if the compliance master plan work would conclude by the time the Braintree facility is operational, potentially resolving the FDA warning letter. He also inquired about the company's perspective on the delayed implementation of Medicare LCDs for skin substitutes.

Answer

CEO Mojdeh Poul detailed that site assessments will finish by Q3, with remediation planning in Q4. While most remediations are targeted for completion by year-end 2025, some may extend into 2026. She affirmed they are working diligently to resolve the warning letter issues before the Braintree facility goes live. Regarding the LCDs, Poul stated that since Integra's business is primarily inpatient, the direct impact is limited, but viewed the focus on products with proven clinical evidence as a positive development.