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NYSE: INSP Inspire Medical Systems, Inc. 8-K

Inspire Medical cuts 2026 revenue guidance to down 4-10%, cites Medicare coding disruption

Filed May 4, 2026 · Period ending May 4, 2026 · ~1 min read

5 key changes 2 high relevance 4 sections

Key Changes

  • high

    Full-year 2026 revenue guidance revised down to $825-875M (4-10% decline vs. 2025's $912M), a sharp reversal from historical 50% five-year CAGR, driven by Medicare CPT coding changes affecting ~10,000 prior cases.

    Exhibit 99.1 view on EDGAR →
  • high

    Exhibit 99.1 view on EDGAR →
  • medium

    Gross margin expanded 180 bps to 86.5% on higher Inspire V system mix, partially offsetting revenue pressure; operating cash flow improved to $12.8M from $(6.7)M prior year.

    Exhibit 99.1 view on EDGAR →
  • medium

    Inspire V system launch progressing with 101 patients at 11 U.S. centers achieving 100% successful implants and no serious adverse events; system now features 3T MRI compatibility.

    Exhibit 99.2 view on EDGAR →
  • medium

    Effective tax rate surged to 571.2% from 28.1% due to stock-based compensation tax shortfalls driven by stock price decline at vesting, impacting GAAP EPS of $(0.39) but not adjusted metrics.

    Exhibit 99.1 view on EDGAR →

Summary

Inspire Medical Systems disclosed a significant business disruption: the CPT code used for approximately 10,000 Inspire V cases in 2025 is no longer available for Medicare reimbursement, forcing physicians and centers to navigate coding alternatives.

This reimbursement uncertainty, combined with the WISeR program implementation, drove management to slash full-year 2026 revenue guidance to $825-875 million—a 4-10% decline versus 2025's $912 million. The revised outlook marks a dramatic deceleration from the company's historical 50% five-year revenue CAGR and suggests the coding disruption is materially impacting procedure volumes.

Management characterized the challenges as temporary and expects a return to revenue growth in 2027, but the near-term impact is severe. Q1 2026 results reflected the early stages of this disruption: revenue grew just 1.6% to $204.6 million with adjusted diluted EPS of $0.10. Gross margin expansion to 86.5% (up 180 bps) provided some offset as the higher-margin Inspire V system gained share, and operating cash flow improved to $12.8 million from negative $(6.7) million in the prior year. The Inspire V launch itself is progressing well with 100% successful implants across 101 patients and new 3T MRI compatibility addressing a patient adoption barrier. However, the reimbursement headwinds are expected to persist through the balance of 2026, making the return-to-growth thesis a 2027 story. Retail holders should monitor whether coding resolution materializes on management's timeline and whether procedure volumes stabilize in coming quarters.

Section-by-Section Diff

Event · Exhibit 99.2

Inspire Medical Systems disclosed Q1 2026 financial results and updated full-year 2026 guidance in an investor presentation.

5 Added
Added Q1 2026 financial results high

Added in current filing · view on EDGAR →

Generated $204.6 million of revenue in the first quarter, a 1.6% increase over the same quarter last year • Achieved gross margin of 86.5% in the first quarter • Generated $13 million in operating cash flow for the first quarter

Inspire Medical Systems reported Q1 2026 revenue of $204.6 million, up 1.6% year-over-year, with an 86.5% gross margin and $13 million in operating cash flow. This represents a significant deceleration from the company's historical 50% five-year revenue CAGR, suggesting potential headwinds in the business.

Added Full-year 2026 guidance high

Added in current filing · view on EDGAR →

2026 Guidance: • FY2026 revenue range of $825M-$875M • FY2026 Adjusted operating income margin between 2%-4% • FY2026 Adjusted EPS $0.75-$1.25

The company provided full-year 2026 guidance with revenue of $825-875 million (representing a decline to flat growth versus 2025's $912 million), adjusted operating margin of 2-4%, and adjusted EPS of $0.75-$1.25. The midpoint revenue guidance of $850 million would represent a 7% decline from 2025, a sharp reversal from prior growth trends.

Added Inspire V system launch progress medium

Added in current filing · view on EDGAR →

Steady progress on the full launch of the Inspire V system in the U.S.

The company reported steady progress on the full U.S. launch of its next-generation Inspire V neurostimulator system, which features improved sensing capabilities, reduced surgical time, and a flexible software platform for future feature upgrades. The Inspire V limited market release involved 101 patients at 11 U.S. centers with 100% successful implants and no serious adverse events.

Added 3T MRI compatibility medium

Added in current filing · view on EDGAR →

3T MRI compatibility

Inspire disclosed that its system now has 3T MRI compatibility, expanding the types of diagnostic imaging available to patients with the implanted device. This addresses a common patient concern and removes a barrier to adoption.

Added Cardiovascular outcomes study medium

Added in current filing · view on EDGAR →

Independent study from VCU of cardiovascular and respiratory outcomes comparing Inspire to CPAP and no therapy

An independent study from Virginia Commonwealth University compared cardiovascular and respiratory outcomes for Inspire therapy versus CPAP and no therapy, adding to the clinical evidence base. The study was published in a peer-reviewed journal and supports the company's value proposition in reducing OSA-related health risks.

Event · Exhibit 99.1

Inspire Medical Systems reported Q1 2026 earnings with 1.6% revenue growth, revised full-year guidance downward citing coding/reimbursement disruption.

4 Added
Added Q1 2026 earnings results high

Added in current filing · view on EDGAR →

First quarter revenue growth of 1.6%

•First quarter diluted EPS of $(0.39); adjusted diluted EPS of $0.10

•First quarter operating cash flow of $12.8 million

Inspire Medical Systems reported Q1 2026 revenue of $204.6 million, up 1.6% year-over-year, driven by market penetration offset by reimbursement disruption and the WISeR program. GAAP diluted EPS was $(0.39) versus adjusted diluted EPS of $0.10. Operating cash flow improved to $12.8 million from $(6.7) million in the prior year period, primarily due to improved working capital.

Added Coding and reimbursement disruption high

Added in current filing · view on EDGAR →

Despite disruption from the coding and reimbursement uncertainty that arose at the beginning of the year, as well as the implementation of the WISeR program, we continued to advance the adoption of Inspire V given its simplified procedure and advanced features. As previously discussed, the CPT code used for approximately 10,000 Inspire V cases in 2025 is no longer available for reimbursement of Medicare cases, requiring physicians, centers, and our team to navigate coding alternatives during the quarter.

The CPT code used for approximately 10,000 Inspire V cases in 2025 is no longer available for Medicare reimbursement, forcing physicians and centers to navigate coding alternatives. Management expects these challenges to persist through the balance of 2026 but believes they are temporary, with a return to revenue growth expected in 2027.

Added Revised 2026 guidance high

Added in current filing · view on EDGAR →

The Company is revising its previously announced revenue outlook to be in the range of $825 million to $875 million, which represents a decline of 4% to 10% compared to 2025. Additionally, the Company now expects annual adjusted operating margin in the range of 2% to 4%, diluted EPS in the range of $0.07 to $0.62 and adjusted diluted EPS in the range of $0.75 to $1.25.

Inspire lowered its full-year 2026 revenue guidance to $825 million to $875 million, representing a 4% to 10% decline versus 2025, down from prior expectations. The company also revised adjusted operating margin guidance to 2% to 4%, diluted EPS to $0.07 to $0.62, and adjusted diluted EPS to $0.75 to $1.25. The downward revision reflects the ongoing coding and reimbursement uncertainty expected to persist through 2026.

Added Gross margin improvement medium

Added in current filing · view on EDGAR →

Gross margin increased 180 bps to 86.5%, primarily due to increased sales mix of the Inspire V system, which has a higher gross margin than the Inspire IV system.

Gross margin expanded 180 basis points to 86.5% in Q1 2026, driven by a higher sales mix of the Inspire V system, which carries a higher gross margin than the prior Inspire IV system. This product mix shift is a positive development despite the revenue headwinds.

Event · Item 7.01 — Regulation FD Disclosure

~400 words

Inspire Medical Systems furnished investor presentation materials for May-June 2026 meetings with investors and analysts.

1 Added
Show 1 minor / wording change
Added Investor presentation materials low

Added in current filing · verify on EDGAR →

In May and June of 2026, the Company will be participating in various meetings with investors and analysts, and a copy of the Company’s presentation materials being used at these meetings is furnished as Exhibit 99.2 hereto and is incorporated herein by reference.

The company disclosed it will participate in investor and analyst meetings during May and June 2026, and furnished the presentation materials it will use at these meetings. The materials are also available on the company's investor relations website.

Event · Item 2.02 — Results of Operations and Financial Condition

~70 words

Inspire Medical Systems announced Q1 2026 financial results via press release.

1 Added
Added Q1 2026 earnings announcement medium

Added in current filing · verify on EDGAR →

On May 4, 2026, Inspire Medical Systems, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2026.

The company disclosed its first quarter 2026 financial results through a press release. The 8-K body does not contain the actual financial figures; those are in the attached press release exhibit.

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