InspireMD (NSPR) 2026财年第二季度业绩电话会议：召回影响与FDA催化剂

核心要点

• 尽管公司主动召回了 CGuard Prime 135 颈动脉支架系统，InspireMD 报告的 2026 年第二季度营收为 180 万美元，同比基本持平。
• 受持续需求而非外汇波动推动，国际业务营收增长 21% 至 210 万美元。
• 与召回相关的 73.4 万美元客户抵扣和 61.2 万美元的存货减值导致毛利润亏损 80 万美元，毛利率为 -43.7%。
• 净亏损从 1320 万美元扩大至 1430 万美元，而每股亏损从 0.26 美元收窄至 0.17 美元。截至季度末，现金、现金等价物及有价证券总额为 3040 万美元。
• 管理层表示，针对 TCAR 的 CGuard Prime 80 以及针对 CAS 的原始 CGuard 平台的潜在 FDA 决定目标仍锁定在 2026 年第四季度。
• 裁员近 20% 预计每年将产生约 900 万美元的成本节省，对成本的全面影响预计将在 2026 年第四季度显现。

核心财务业绩

运营支出增加的主要原因是美国商业化团队的人员成本增加，以及 SwitchGuard NPS 和用于 TCAR 的 CGuard Prime 80 的研发、临床与监管支出增加。一般及行政薪酬费用的降低抵消了部分增加。

业务与运营表现

5 月初宣布的主动召回通过暂停 CGuard Prime 的销售以及对未使用的 CGuard Prime 135 产品给予抵扣，影响了美国业务的营收。在召回生效前，公司在美国仅产生了不到一个月的销售额。

国际业务仍是主要营收驱动力。InspireMD 在美国以外地区已售出超过 7.5 万件 CGuard 植入物。管理层表示，目前正在审查定价和毛利假设，以提高国际业务除了营收增长之外的利润贡献。

对于重新设计的 CGuard Prime 135 输送系统，公司已确定所需的改进，并正在进行设计验证和性能测试。管理层表示，重新设计的输送机制表现符合预期，包括在具有挑战性的解剖结构中。

公司还入组了 SwitchGuard 神经保护系统关键 CGUARDIANS III 研究的第一位患者。管理层称早期入组和研究者的反馈积极，同时指出试验的扩展将部分取决于现有资源。

管理层指引

• 用于 TCAR 的 CGuard Prime 80：在取决于监管审查的前提下，管理层继续看好在 2026 年第四季度获得 FDA 批准的可能。
• 用于 CAS 的原始 CGuard 平台：公司目前预计 FDA 将在 2026 年第四季度做出决定。管理层表示，该时间节点反映了测试要求以及需要为公司和 FDA 的回复周期留出时间。
• 用于 CAS 的重新设计的 CGuard Prime 135：管理层继续以 2027 年上半年重新进入美国市场为目标；如果测试要求和 FDA 审查途径有利，则有可能更早获得决定。
• SwitchGuard：公司维持了此前讨论的 2027 年下半年获得批准并上市的时间表，同时强调患者入组进度将影响时间。
• 成本削减：大多数重组行动已在进行中。管理层预计 2026 年第三季度将实现部分成本节省，而调整后的成本结构将在 2026 年第四季度产生全面影响。
• 重组费用：InspireMD 预计 2026 年第三季度将产生 90 万至 120 万美元与裁员补贴及相关成本相关的费用。

风险与关注点

重新进入美国市场的时间仍取决于 FDA 的审查。对于 CGuard Prime 135，关键的不确定因素包括是否需要进行额外的生物相容性测试，以及 FDA 是否同意对设计变更进行加速审查。

召回事件继续对营收、毛利率和存货价值产生影响。尽管管理层认为该问题在技术上已解决且可控，但商业化重新上市的时间仍取决于监管部门的批准。

SwitchGuard 的研发进度取决于临床入组情况和可用资源。公司还在平衡现金留存与为美国市场重新上市保留足够商业化能力的需求。

分析师问答亮点

分析师高度关注监管审批时间。管理层将原始 CGuard 系统的预期批准时间从 2026 年第三季度推迟至第四季度归因于对测试、公司回复和 FDA 审查周期的合理预留，而非新发现的产品问题。

关于 CGuard Prime 135，管理层表示设计验证测试正在进行中。已向 FDA 提交了早期预提交申请。若能避免额外的生物相容性测试并获得更快的审查流程，可能会缩短目前 2027 年上半年的时间表，但公司尚未做出加速承诺。

关于商业化准备情况，InspireMD 表示已保留关键一线人员，并利用理赔数据、区域规划和客户审批流程完善了上市策略。管理层表示医生的兴趣依然浓厚，但这些声明反映了公司在获得监管批准前的评估。

管理层将 SwitchGuard 描述为其长期 TCAR 战略的基础，因为每台 TCAR 手术都会同时使用支架和神经保护装置。公司认为，若获得批准，同时提供这两种产品可能会增加其营收和毛利空间。

财报电话会议完整文字记录

完整财报电话会议逐字稿

管理层陈述

Operator

Good morning, and welcome to InspireMD Second Quarter 2026 Earnings Conference Call. [Operator Instructions] As a reminder, this call is being recorded for replay purposes.

Joining us today from InspireMD are Marvin Slosman, Chief Executive Officer; and Mike Lawless, Chief Financial Officer.

During this call, management will make forward-looking statements, which are based upon management's current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. These forward-looking statements involve risks and uncertainties that may cause actual results to differ materially from those expressed in such forward-looking statements. More detailed information about the company and the risk factors that may affect the realization of forward-looking statements is set forth in the company's filings with the U.S. Securities and Exchange Commission, including its annual report on Form 10-K, quarterly report on Form 10-Q, any updates in its current reports on Form 8-K as well as InspireMD's press release that accompanies this call, particularly the cautionary statements made in it.

During the call today, the company may also discuss certain non-GAAP financial measures. For a more detailed discussion of these non-GAAP financial measures and historical reconciliation to the most closely comparable GAAP measures, please refer to the company's earnings release. This call contains time-sensitive information that is accurate only as of today, August 17, 2026. Except as required by law, InspireMD disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call.

It is now my pleasure to turn the call over to Marvin Slosman, Chief Executive Officer. Marvin, please go ahead.

Marvin Slosman

Thank you, operator, and good morning, everyone. The second quarter was an important period for InspireMD. While our reported financial results reflect the accounting impact of the voluntary recall of our approved CGuard Prime 135 carotid stent system, the quarter was defined by the actions we took to strengthen the business, sharpen our execution and position our company for a successful return to the U.S. market. Over the last several months, we've remained focused on 4 priorities: optimizing our international business, advancing our key regulatory programs and milestones to U.S. market reentry, implementing design enhancements to the CGuard Prime delivery system and aligning our organization and cost structure around these priorities. I believe we are making meaningful progress on each of these objectives.

Notwithstanding our temporary absence from the U.S. market, our total revenue was essentially unchanged from the second quarter of last year. It's important to note our international business continued to perform very well, growing approximately 21% year-over-year, reflecting continued physician adoption and strong demand for CGuard across our international markets. At the same time, our reported U.S. revenue reflects customer credits associated with the voluntary recall announced at the beginning of May. Those credits more than offset gross U.S. product sales during the quarter and therefore, obscure the underlying performance of the business.

Importantly, our confidence in the CGuard implant remains the foundation value driver of our business and will continue to be the asset that builds our market leadership regardless of which delivery method is chosen for each patient's need. The clinical outcomes and evidence we've developed over many years have set a new standard of care, translating to physician enthusiasm and utilization, which remains strong, giving us confidence as we anticipate our U.S. relaunch. We continue to believe CGuard is the most differentiated technology available for carotid revascularization and stroke prevention.

Turning now to our CGUARDIANS II submission of approval of our CGuard Prime 80 platform for TCAR. We recently announced an outstanding 30-day results from the trial, which we believe strengthen our pending submission. In fact, our latest discussions and feedback from FDA remain constructive and interactive and all signals point to potential approval in the fourth quarter, as we previously indicated. Once approved, the CGuard Prime 80 platform would essentially double our addressable market by offering our implant for TCAR in addition to CAS procedures. We also enrolled the first patient in CGUARDIANS III, our pivotal study evaluating next-generation SwitchGuard neuroprotection system. Taken together, we're encouraged by the progress across our comprehensive TCAR programs.

Also, as previously noted, our submission of the original CGuard platform for CAS, clinically proven in over 75,000 global OUS cases continues, and based on the progress to date, we currently expect a decision from FDA in the fourth quarter of this year. Should these anticipated approvals be realized, we would have both TCAR and CAS platforms commercially available before the end of the year, giving us the opportunity to address the entirety of the approximately 75,000 annual stenting procedures in the U.S.

When we spoke to you last quarter, we outlined a clear plan to address the improvements for the CGuard Prime 135 CAS delivery system. Since then, we've identified the required design modifications, initiated validation and performance testing and continue to work closely with the FDA as we advance these improvements with a completed early submission of our pre-sub dossier. These modifications and testing have gone exceedingly well, and we are optimistic that the associated time lines of first half of 2027 for market reentry of this platform has the potential for an earlier approval.

While this has clearly been a challenging time for the company, I believe our ability to weather these setbacks has made us a stronger and more focused organization. The CGuard 135 delivery system modifications and remediation is well understood. The path forward is clearly defined, and our team remains fully focused on implementation.

During the quarter, we also took decisive actions to better align our organization and cost structure with our near-term priorities. These decisions allow us to focus our resources on the regulatory and commercial milestones that we believe will have the ability to create the greatest long-term value for our shareholders. We also believe we've created a leaner, more efficient and focused organization that is better positioned to execute, not only to return CGuard to the U.S. market, but to expand access for our physicians and patients they treat.

Before turning the call over to Mike, I'd like to leave you with 4 key messages. First, the underlying fundamentals of our business remain strong as demonstrated by continued international growth, physician anticipation for our CGuard implant as what we believe is the best treatment for carotid disease with clear line of sight for our U.S. market relaunch.

Second, we believe the voluntary recall is proving to be a well-defined and manageable event. We understand the issue. We've identified the solution, and we are executing against a clear regulatory pathway to reestablish traction and growth.

Third, we continue to advance multiple regulatory catalysts, including CGuard Prime 80 for TCAR, the redesigned CGuard Prime 135 platform for CAS, the original CGuard delivery system as well as our next-generation SwitchGuard neuroprotection system.

And finally, we've aligned our organization and cost structure to support these priorities while positioning InspireMD for long-term sustainable growth.

While we still have important work ahead of us, I believe today, we are a more focused and disciplined company and ultimately have better positioned ourselves for success.

With that, I'll turn the call over to Mike to review the financials. Mike?

Michael Lawless

Thank you. As Marvin described, the second quarter financial results need to be interpreted in the context of the voluntary recall that we announced at the beginning of May. For the second quarter of 2026, total revenue was $1.8 million, which was essentially flat with the revenue for the second quarter of 2025.

The recall action affected our reported revenue in 2 ways. First, we ceased commercial sales of CGuard Prime late in April, so we generated less than 1 month of sales in the U.S. before the recall took effect. Second, we booked a $734,000 credit for the return of the CGuard Prime 135 product that had not yet been consumed by our customers. International revenue was $2.1 million, representing growth of 21% versus the same quarter a year ago. This performance continues to reflect the growing global demand for our CGuard stent platform. The entirety of international growth was driven by continued demand, while changes in foreign exchange rates were immaterial.

Gross profit for the second quarter of 2026 was a loss of $0.8 million or negative 43.7% of revenue compared to a gross profit of $0.3 million or 17.6% of revenue for the second quarter of 2025. This decline in gross margin resulted primarily from the $734,000 credit to revenue that I described previously and a $612,000 impairment charge for CGuard Prime 135 inventory on our books that was no longer commercially viable as a result of the recall.

On a non-GAAP basis, which excludes the impact of the recall-related customer credits and impairment charge, adjusted gross profit was $0.6 million. A reconciliation of adjusted gross profit to gross profit, the most directly comparable GAAP measure, is included in today's earnings release and posted in the Investor Relations section of our website.

Total operating expenses for the second quarter of 2026 were $13.7 million, an increase of $0.4 million compared to $13.3 million for the second quarter of 2025. The increase was primarily due to greater headcount-related expenses for the U.S. commercial team and higher development, clinical and regulatory expenses related to SwitchGuard NPS and CGuard Prime 80 for TCAR, partially offset by lower general and administrative compensation expenses.

Financial income was $121,000 as compared to a loss of $132,000 for the second quarter of 2025. Net loss for the second quarter of 2026 totaled $14.3 million or $0.17 per basic and diluted share compared to a net loss of $13.2 million or $0.26 per basic and diluted share for the same period in 2025. As of June 30, 2026, cash and cash equivalents and marketable securities were $30.4 million compared to $54.2 million at the end of 2025.

As Marvin discussed, we have proactively taken actions to reduce our cost structure and improve our financial flexibility and operational efficiency. Included in these efforts was a workforce reduction action initiated in the third quarter that reduces the number of positions in our organization by almost 20% and saves the company approximately $9 million on an annual basis. We expect to incur a restructuring charge of between $900,000 and $1.2 million in the third quarter to account for the severance and related costs associated with this workforce reduction event.

This concludes our prepared remarks. We will now open the call for questions. Operator?

Operator

[Operator Instructions] Our first question comes from Adam Maeder with Piper Sandler.

分析师问答

Adam Maeder

A couple for me, and maybe we can just start on the CAS side of the business. So first, original CGuard delivery system approval timing for U.S., if I heard correctly, was Q4. I think in the last earnings call, you mentioned Q3. So a little bit of a wiggle there versus prior expectations. And I don't mean to nitpick over a couple of months, but can you just talk about kind of what's driving the shift there? Any color you can give us on your recent interactions with FDA? That's question one. And then I have another 1 or 2 for you guys.

Marvin Slosman

Thanks, Adam. Thanks for the question. I think the wiggle, as you mentioned it, is we're just trying to be realistic about the regulatory time frames as always, request from FDA and just general time frames. We have testing that has been required and is completed, and we're just trying to make sure that we're understanding a realistic approval time line here relative to the workload, our responses to FDA and so forth. So I think we're on top of the details and what's necessary and required. So it's really nothing more than that. We just want to be realistic about giving ourselves some room here on these responses and FDA's response back, specific to the legacy system.

Adam Maeder

Yes. Perfect. Okay. And then if we switch over to CGuard Prime, the delivery system there. Good to hear you're still tracking towards first half 2027 approval for that technology. I guess my question is what's left to do before submission? And it would be really helpful if you could put a finer point on FDA submission timing as folks just try and understand how derisked the first half '27 approval it truly is. And then I had one more for you guys.

Marvin Slosman

Sure. The progress on the 135 technical and the Prime system on the 135 Prime technical improvements is really solid, Adam. In fact, we feel confident that we've not only solved the delivery challenges, but produced a solution that performs exactly as we anticipated with the trackability and even in challenging anatomy and so forth. And so the delivery mechanism performs well. We are in the process right now of doing DV testing and making sure that all of the technical work that we've done from the engineering group is now stacking up in terms of measured approach.

So we're confident in the system. We're confident that we've solved it, and this is our platform for the future. So we originally guided around a first half 2027 approval. We think that, that remains realistic. There's a couple of long poles in the tent that we're still sorting out related to biocomp testing, the statutory review process that FDA puts on these things. We have submitted early our pre-sub request to FDA to review all of the results to date and our anticipated response. We hope that, that gives us a little more clarity and is more favorable. But if we can eliminate some of these long pole items, we believe that there is a possibility that we could pull that approval process in. But right now, we're calling the first half of '27 as being realistic, and we're optimistic that we can make those improvements.

Adam Maeder

Okay. And maybe just one last one. Sorry, it's another kind of regulatory question. But just flipping over to SwitchGuard, which I think is important, your proprietary TCAR system. So I think in June, you enrolled the first patients in that study. Just any comments you can give us, color you can give us, Marvin, on the enrollment progress there and kind of how that trial is advancing? And just from a time line standpoint, I just want to confirm that you're still tracking to back half 2027 for U.S. approval and launch.

Marvin Slosman

Yes. The enrollments thus far have gone very well. We don't take any of that for granted. Obviously, this is the first time SwitchGuard has been used in human applications. So I think the investigators are very pleased with the performance, and we continue to enroll in the trial. Our expansion of that trial will, to a certain extent, depend on the resources that are available to us. But so far, we have initiated sites that we believe are high volume and enthusiastic about SwitchGuard and continue to progress in those enrollments with the time line that you had previously mentioned as being what we're calling at this point. Obviously, the enrollment process will determine time lines. But so far, we're really pleased about the responses and the performance of the device itself.

Operator

Comes from Frank Takkinen with Lake Street Capital Markets.

Frank Takkinen

I wanted to follow up on the comments around some of the cost saving initiatives. First, when should we expect those to be fully realized? Understanding there's going to be some restructuring expense that occurs in Q3. When should we see kind of the first quarter of the refreshed operating expense run rate? And then you made a comment related to a 20% reduction in headcount. Can you maybe talk to the distribution of where those 20% came from inside the organization?

Michael Lawless

Frank, good questions. So in terms of the timing for when we'll realize those cost savings, those -- the vast majority of those actions that we described have already been set in motion. I would expect that we should see the full impact of that -- those cost savings in Q4 of this year. There will be some partial savings in Q3, but there will be also some offsetting costs associated with restructuring. So from a clean standpoint, I would say Q4 should be a good view of what the new cost structure looks like.

Marvin Slosman

Frank, let me jump in on the second part of your question there. Obviously, we want to make sure that we're anticipating a very aggressive relaunch, and we've built a plan to enable that commercial readiness built for that momentum. So even though we're conserving our financial resources to extend the cash runway, we're trying to strike a balance in maintaining the commercial readiness to do so. So reducing these layers makes a lot of sense to us. But at the same time, I think we're continuing to maintain the strength of our commercial organization to make sure that we're ready in a fairly tight window here that we're out of the gate relaunching and doing so properly with a great team on the field. So we're -- we feel good about the ability to do that.

Frank Takkinen

Okay. Very helpful. I just wanted to follow up on one of Adam's questions on the Prime system. Just hoping you can put a little bit of a finer point on what the kind of key variable to sliding that time line is. I know you've mentioned kind of maybe earlier part of first half '27, if you're able to accelerate that process a little bit, but you're remaining conservative and to keep the first half '27 guidance. But what is the key variable that kind of changes that time line? And is that something that's more in your control? Or is that related to maybe how quickly the FDA can process?

Marvin Slosman

Yes, it's a great question, Frank. So as I mentioned, there's 2 testing scenarios that we're looking at here. Biocomp testing, it takes a bit of time. We don't believe that is necessary, but we need to validate that with -- obviously, with FDA and their review of this under the pre-sub scenario that we have set up. And then the statutory review process, we would be looking for more of an accelerated review of those changes that we've made to the prime. And if FDA agrees with that, those could pull those time lines in significantly.

But again, no commitments at this point. We're still guiding around all of those factors being as they are. So first half of '27 is what we're calling at the moment. But given the fact that we believe we've solved this problem technically with minimal implications from a technical point of view, we're hopeful that FDA agrees with that assessment and that we can pull that in.

Operator

Our next question comes from Marie Thibault with BTIG.

Marie Thibault

I wanted to ask a question here on sort of the updated commercial strategy. If all goes well, you'll have the relaunch and then other launches to follow pretty quick succession here. So I know you have a new Head of Sales and Marketing, maybe a smaller tighter team on the commercial side. So just any updates on how you're thinking about the launches commercially? Any changes to the strategy? Any thoughts on VAC committee processes, all of those sorts of details would be helpful.

Marvin Slosman

Sure. Thanks, Marie. Glad to have you on the call, by the way. So I think what we've spent a lot of time doing over the last month or so is making sure that we are optimizing the structure of our field organization for the folks that performed really well on our initial launch. As you know, we take a very deliberate approach to where carotid procedures are through claims data and territory management. We're looking very closely at time to productivity of our team. So this is a very deliberate and structured approach. The playbook for our commercial launch and relaunch has been looked at very closely.

We have a new Head of Sales and Marketing who has real clarity on how we go about doing that. And so we're thrilled with the group that we have on the field, their ability to understand where their customers are and what the anticipated and pent-up demand is going to be. And so obviously, that playbook will be executed, and we feel like that the group that's with us now will be able to reestablish our commercial presence quickly.

VAC committees and otherwise, we continue to look closely at where we have those approvals and making sure that customers understand time lines and our process here. So that part of the work, we spent a lot of time looking at to make sure we get the full benefit of the value of our relaunch. We know that there is pent-up and anticipated demand for this product. And this voluntary recall gave us the opportunity to take a quick pause and make sure that we're being very efficient and realistic and aggressive about our relaunch plans. So that feels very good.

Marie Thibault

Okay. That's wonderful to hear. A quick follow-up here. You mentioned, I think, international grew over 20% this quarter. What's been driving that? That's a really nice bright spot. I'm curious if that's a sustainable growth there.

Marvin Slosman

Yes, Marie. I think it's a great question. Our OUS business has matured very well over the last several years. Remember, we've been in the OUS markets now for years, sold over 75,000 implants. We think, first of all, the performance of this device drives world-class outcomes and that the physicians in our OUS markets are very accustomed to that being the new standard of care, which we hope to translate into the U.S. market as well.

We've grown that OUS business significantly and nicely over time, but we also recognize the need to pivot a bit and look for higher margins and margin expansion in those markets. It's obviously not as a robust economic market as the U.S. And so we're beginning to look closely at fine-tuning those pricing and margin assumptions so that we can count on that business not only being a great top line business, but being able to contribute at least partially on the bottom line. So we're thrilled to have the results that we do in our OUS market.

Operator

Our next question comes from Jeremy Pearlman with Maxim Group.

Jeremy Pearlman

First, I guess, are you in touch with the physicians who are using the recalled 135-centimeter delivery system? And what's their take on the time line? And are they going to be happy to reengage with the company and the CGuard Prime once it's hopefully recleared?

Marvin Slosman

Yes, Jeremy, great question. We are absolutely in touch with all of our customers, including the current users and new users. The anticipation in this marketplace is palpable. When we launched this product, we saw a terrific reaction to a new technology that came to market after 20 years of older technology. And we're, of course, in touch with all of those customers. I think they're excited and anticipating having this product back in their hands is unanimous. It's consistent, it's unanimous. That's why our sales team, we've kept them together and allowed them to continue to cultivate those relationships.

And the expectation is as soon as we have approval of the 135 as well as the approval on the 80 for TCAR, we will be able to transfer that interest and enthusiasm into revenue in a quick fashion. So that's the work of the sales organization right now is to prepare for that relaunch and the feedback from customers is excitement and enthusiasm for having it back in their hands.

Jeremy Pearlman

Okay. That's great to hear. And then just last question for me. Regarding how important is the SwitchGuard to the long-term TCAR strategy, let's say, versus just the CGuard 80? I mean, how much does that -- obviously pending FDA approval, how much does that materially expand your addressable TCAR market? Like -- and what would -- why would a physician, let's say, use the entire SwitchGuard system versus a prior system with just the CGuard 80-centimeter?

Marvin Slosman

Yes. It's very fundamental to our overall TCAR strategy. The fact is that for every TCAR procedure, there's an implant use, there's a stent use and then a neuroprotection device that's also used in the procedure, and we felt it was important to have both. We've made some improvements on the current predicate in the market that's approved with our SwitchGuard. So we think we will have a device that has some features and functions that the customers have been looking for that are otherwise unavailable.

Obviously, the sales dollars and margin associated with that product are significant. And so the ability to address the entirety of the TCAR market with both the implant and the neuroprotection system here are really fundamental to our TCAR strategy overall. So we think we benefit by better technology and obviously, internally with higher revenue and margin opportunities. So it remains a fundamental part of our overall plan.

Operator

That concludes today's question-and-answer session. I'd like to turn the call back to Marvin Slosman for closing remarks.

Marvin Slosman

So I'd like to thank everyone again for joining the call today and the continued interest in InspireMD. We certainly recognize we have important work ahead of us, but we believe that we've made meaningful progress over the past several months. We've got a clear path forward, multiple important regulatory catalysts ahead and a team that remains fully focused on execution. We appreciate the continued support and look forward to updating on our progress next quarter.

Operator

This concludes today's conference call. Thank you for participating. You may now disconnect.