InspireMD, Inc. (NSPR) Earnings
InspireMD, Inc. is expected to report next earnings on November 10, 2026 (in NaN days), with a consensus EPS estimate of $-0.15. NSPR has beaten EPS estimates in 8 of its last 11 reported quarters (average surprise +7.2% over the last four).
| Report date | EPS est | EPS actual | Surprise | Revenue | Rev. surprise |
|---|---|---|---|---|---|
| Aug 17, 2026 | $-0.20 | $-0.17 | +15.0% | $2M | +28.1% |
| May 4, 2026 | $-0.19 | $-0.16 | +15.8% | $3M | +25.8% |
| Mar 18, 2026 | $-0.19 | $-0.14 | +27.6% | $3M | +32.5% |
| May 9, 2025 | $-0.17 | $-0.22 | -29.4% | $2M | +1.9% |
| Mar 12, 2025 | $-0.20 | $-0.19 | +5.0% | $2M | +34.2% |
| Mar 6, 2024 | $-0.20 | $-0.16 | +20.0% | $2M | +14.4% |
| May 15, 2023 | $-0.68 | $-0.53 | +22.1% | $1M | +23.9% |
| Mar 8, 2022 | $-0.78 | $-0.53 | +32.1% | $1M | +6.2% |
| Aug 10, 2021 | — | $-0.46 | — | $1M | -5.6% |
| Mar 9, 2021 | $-0.90 | $-1.50 | -66.7% | $158000 | — |
| Aug 5, 2020 | $-5.25 | $-3.00 | +42.9% | $313000 | -42.9% |
| Mar 10, 2020 | $-8.55 | $-8.55 | +0.0% | $1M | — |
Source: company filings + earnings calendar. For informational purposes only — not investment advice.
Earnings call summary
Q2 FY2026 · August 17, 2026
AI summary of management’s prepared remarks and analyst Q&A. For informational purposes only — not investment advice.
Management highlights
- Core Business & Recall Response * The quarter was defined by operational actions following the voluntary May 2026 recall of the Seaguard Prime 135 carotid stent system. Management has identified the required design modifications to the delivery system, initiated validation and performance testing, and submitted an early pre-submission dossier to the FDA. * The underlying fundamentals of the business remain strong, with continued international growth and sustained physician enthusiasm for the C-Gard implant, which management believes is the most differentiated technology for carotid revascularization and stroke prevention. * A 20% workforce reduction was implemented in Q3 2026 to align cost structure with near-term priorities, extending cash runway while retaining core commercial team capacity to support upcoming U.S. relaunches. The restructuring is expected to generate $9 million in annual cost savings. - Regulatory & Clinical Progress * 30-day results from the C-Guardians 2 trial for the C-Guard Prime 80 platform for TCAR procedures were outstanding, and interactions with the FDA remain constructive. The original C-Guard platform submission for CAS continues, and the first patient has been enrolled in the C-Guardians 3 pivotal trial for the next-generation SwitchGuard neuroprotection system. - Commercial Preparation * Management has refined the commercial launch playbook for upcoming U.S. relaunches, optimized territory management based on historical procedure data, and retained a focused, high-performing field sales team to capitalize on pent-up physician demand. International operations are being adjusted to improve margins after years of consistent top-line growth.
Guidance
- FDA approvals for both the original C-Guard platform for CAS and the C-Guard Prime 80 platform for TCAR are now expected in Q4 2026, revised from the prior expectation of Q3 2026 for the original C-Guard platform. If approved, this will give InspireMD commercial access to the full ~75,000 annual U.S. carotid stenting procedures by the end of 2026. - U.S. market reentry for the redesigned Seaguard Prime 135 delivery system is guided for the first half of 2027, with management noting there is potential for an earlier approval if FDA agrees to an accelerated review of design changes. - Full annualized cost savings from the 20% workforce reduction will be fully realized starting in Q4 2026, with partial savings in Q3 2026 offset by $900,000 to $1.2 million in Q3 2026 restructuring charges. - The C-Guardians 3 pivotal trial for SwitchGuard remains on track to target U.S. approval in 2027, with enrollment proceeding as planned to date.
Segment performance
InspireMD's total Q2 2026 revenue was $1.8 million, flat year-over-year compared to Q2 2025. - U.S. Revenue: Reported U.S. revenue was negative after accounting for $734,000 in customer credits for recalled Seaguard Prime 135 carotid stent systems; gross U.S. product sales during the quarter were fully offset by these recall credits. - International Revenue: International revenue reached $2.1 million, growing 21% year-over-year, and contributed 100% of total net revenue in the quarter (as U.S. net revenue was negative after recall adjustments). Foreign exchange impacts were immaterial to this growth.
Risks & headwinds
- Forward-looking statements regarding regulatory approval timelines, commercial launch success, and enrollment progress are inherently uncertain, and actual results may differ materially due to factors including FDA review timelines, regulatory feedback requests, and trial enrollment rates. - The recall of the Seaguard Prime 135 system created a $734,000 negative revenue impact and a $612,000 inventory impairment charge in Q2 2026, resulting in a negative gross profit margin for the quarter. - The company's cash runway totaled $30.4 million as of June 30, 2026, down from $54.2 million at the end of 2025, creating dependence on successful regulatory approvals and commercial relaunch to maintain long-term operations. SwitchGuard trial enrollment progress is partially dependent on available financial resources.
Analyst Q&A
Q: The original C-Guard approval timeline shifted from Q3 to Q4 2026 — what is driving this change, based on recent FDA interactions?
A: The timeline shift is only to reflect realistic regulatory timeframes, including FDA workload and required post-submission response windows. All required testing for the original C-Guard platform is complete, and there are no outstanding issues that prompted the change; management simply added a small buffer to account for potential processing delays.
Q: What is the key variable that could accelerate the Seaguard Prime 135 approval timeline ahead of the guided first half of 2027? Is this timeline dependent on FDA processing speed or internal work?
A: The main open items are biocompatibility testing timing and the potential for FDA to grant accelerated review of the finalized design changes. Management has already solved the technical delivery issue, but biocompatibility testing is currently the longest lead internal item. If FDA agrees that accelerated review is appropriate for these modifications, approval could be pulled in significantly.
Q: What is the role of the SwitchGuard neuroprotection system in InspireMD's long-term TCAR strategy, how does it expand the addressable market, and why would physicians choose it over existing alternatives paired with C-Guard 80?
A: SwitchGuard is fundamental to the full TCAR strategy, as every TCAR procedure requires both a stent implant and a neuroprotection device. It includes improved features that are not available on current predicate devices, and offering both products allows InspireMD to capture the full revenue and margin per procedure, rather than only the margin from the stent alone.
Q: What is driving strong international revenue growth, and is this growth sustainable?
A: Growth is driven by long-standing physician adoption of C-Guard, which is considered a new standard of care in international markets with proven outcomes across more than 75,000 implants. Management is now focused on refining pricing and expanding margins in international markets to make the segment more profitable on a bottom-line basis, while maintaining top-line growth.