What RxSight, Inc. told the SEC could break it.

RxSight depends on third parties — including single and sole source suppliers — to manufacture certain components and subcomponents of its LAL/LDD products (off-the-shelf chemicals, microchips on printed circuit boards, cables, sub-assemblies and custom parts) and to supply raw materials, primarily the chemicals for its light-adjustable lens; it does not have long-term supply agreements or guaranteed commitments (relying on 18–24-month purchase/blanket orders), making it vulnerable to supply disruptions, quality failures and price increases that could halt production of its key product.

“We rely on third parties, including single and sole source suppliers, to manufacture certain components and subcomponents of our products and to provide raw materials, primarily chemicals for our LAL. We do not have long-term supply agreements with, or guaranteed commitments from our suppliers, including single and sole source suppliers.”

RxSight's commercial sales are concentrated in the U.S. market (where it runs its razor/razor-blade model focused on U.S. cataract surgeons), and although it is growing its presence abroad it does not anticipate meaningful near-term sales from non-U.S. regions — even though roughly 78% of premium IOL procedures in 2025 occur outside the U.S.; this U.S. concentration leaves its revenue exposed to U.S.-specific reimbursement, competitive and adoption dynamics and limits near-term geographic diversification.

“While we are growing our presence outside the U.S., we do not anticipate meaningful near-term sales from these non-U.S. regions.”

RxSight's revenue is concentrated in a single consumable product line: LAL revenue comprised 80% of total revenue in 2025 (up from 69% in 2024), within a 'razor and razor blade' model where placed Light Delivery Devices (LDD) drive recurring LAL sales; this concentration means any clinical, manufacturing, competitive, reimbursement or adoption setback specific to the LAL platform would have an outsized effect on its revenue and growth.

“Gross margin increased to 76.6% in 2025 from 70.7% in 2024, primarily due to favorable product mix from a greater percentage of revenue from LAL sales, with LAL revenue comprising 80% of revenue in 2025, compared to 69% of revenue in 2024.”

As a regulated ophthalmic medical-device maker, RxSight's ability to sell depends on regulatory clearances: its RxSight system has FDA approval for the U.S. and approvals in Europe, Canada, Mexico, Singapore, Australia and South Korea, and expansion into new large cataract markets requires obtaining additional regulatory approvals; delays, denials, post-market requirements, or adverse changes to device regulation or approvals in key markets could constrain its sales and growth.

“Our RxSight system has regulatory approval in the U.S., Europe, Canada, Mexico, Singapore, Australia and South Korea.”