Inspire Medical Systems, Inc. (INSP) SEC Filings & Earnings Calls

Reimbursement Uncertainty

“These and other recent coding and reimbursement decisions (particularly the uncertainty of the decisions and volatility of the announcements from multiple stakeholders) have adversely impacted our revenue in the first half of 2026 and we anticipate that this will continue to adversely impact revenue during the remainder of 2026.” · word for word

GLP-1 Competition

“In the short-term we currently believe our revenue is being adversely impacted by the increasing prevalence and adoption of GLP-1s.” · word for word

WISeR Program Delays

“During the first half of 2026, we experienced delays due to the new WISeR requirements for traditional Medicare procedures in the six WISeR states which adversely impacted our revenue in the first half of 2026.” · word for word

Revenue decline due to coding and reimbursement changes in U.S.

“Revenue decreased 7.6% to $200.6 million, primarily driven by a decline in U.S. revenue, partially offset by growth in International revenue. The U.S. decline was driven primarily by the impacts of evolving coding and reimbursement environment.” · word for word

Restructuring execution risk for Project Horizon

“The Company expects to incur a total of $20 million to $25 million of pre-tax restructuring charges in connection with the first phase of Project Horizon” · word for word

No material risk; routine board retirement.

“Retirement not due to any disagreement with the company.”

Potential dilution from equity plan increase, but relatively small.

“increase of 2,600,000 shares”

Coding and reimbursement uncertainty

“These and other recent coding and reimbursement decisions (particularly the uncertainty of the decisions and volatility of the announcements from multiple stakeholders) have adversely impacted our revenue in the first quarter and we anticipate that this will continue to adversely impact revenue during 2026.” · word for word

WISeR prior authorization program

“During the first quarter, we experienced delays due to the new WISeR requirements for traditional Medicare procedures in the six WISeR states which adversely impacted our revenue in the first quarter. We anticipate that this will continue to adversely impact revenue for the remainder of 2026.” · word for word

GLP-1 competition

“In the short-term we currently believe our revenue is being adversely impacted by the increasing prevalence and adoption of GLP-1s.” · word for word

Tax rate volatility

“The increase in the effective tax rate was primarily driven by shortfalls related to stock-based compensation, which were driven by a decline in our stock price at award vesting and exercise compared to grant-date fair value (tax shortfall).” · word for word

Underwater Stock Options

“nearly 90% of outstanding stock options held by our employees had exercise prices above the current market price of our common stock, meaning they were underwater on such date and had zero intrinsic value.” · word for word

Equity Compensation Dilution

“Projected overhang under all plans (shares reserved and available for outstanding awards under the 2018 Plan, 2017 Plan, 2007 Plan and additional shares requested under the A&R 2018 Plan) 7,788,566 27.05%” · word for word

Stock Price Volatility

“our stock price has undergone a period of increased volatility” · word for word

Reimbursement Uncertainty

“shifts in the reimbursement and coding landscape – as well as perceived uncertainty in the medical device reimbursement process” · word for word

GLP-1 competition for OSA

“If GLP-1s are successful in treating OSA in an indication for which Inspire therapy is approved, demand for our Inspire system for patients with that indication could be reduced.” · word for word

DOJ False Claims Act investigation

“On January 17, 2025, we received a civil investigative demand (CID) from the Department of Justice U.S. Attorney’s Office for the District of Minnesota pursuant to the False Claims Act.” · word for word

Securities class action litigation

“On December 22, 2025, the Indiana Public Retirement System... filed a putative securities class action... The Indiana PRS Lawsuit arises from the same underlying subject matter as the City of Pontiac Lawsuit.” · word for word

CMS WISeR program disruption

“So far, the impact on our overall sales volumes from WISeR cannot be quantified, but it has caused some confusion among customers in the six states that are part of the program.” · word for word

Reimbursement coding change for Inspire V may reduce physician fees and adoption.

“we believe the code will transition to CPT code 64582 for the Inspire V procedure, including the use of a -52 modifier ... While we are disappointed with this result, this clarification provides direction for us going forward” · word for word

Reimbursement coding uncertainty; guidance excludes any potential benefit.

“Our outlook does not include any contribution from increased reimbursement at this time, and we will continue to provide updates, including on our upcoming earnings call.” · word for word

Operating expenses increased 17% YoY, outpacing revenue growth, partly due to litigation costs.

“Operating expenses were $183.1 million for the third quarter of 2025, as compared to $156.5 million in the corresponding prior year period, an increase of 17%.” · word for word

GLP-1 Drug Competition

“If GLP-1s are used to treat OSA in an indication for which Inspire therapy is approved, demand for our Inspire system for patients with that indication could be reduced.” · word for word

Product Transition Disruption

“we anticipate that the occurrence of patients and physicians delaying Inspire therapy and the destocking by some of our customers of their existing Inspire IV inventory may impact our consolidated revenue until Inspire V is fully available” · word for word

ENT Surgeon Capacity Constraint

“partially offset by ENT surgeon capacity constraints” · word for word

Single Source Supplier Concentration

“Many of these suppliers are currently single source suppliers.” · word for word

Inventory Obsolescence Risk

“we recorded a charge of $2.1 million for excess component parts related to our Inspire IV system” · word for word