Ceribell Inc (CBLL) 2025 Q3 法說會逐字稿

Good afternoon and thank you all for participating in today's call. Joining me from Sarabelle are Jane Chao, co-founder and Chief Executive Officer, and Scott Blumberg, Chief Financial Officer. Earlier today, Ceribell issued a press release announcing financial results for the quarter ended September 30, 2025. A copy of the press release is available on the investor relations section of the company's website.

Before we begin, I'd like to remind you that management will make remarks during this call that include forward-looking statements within the meaning of federal securities laws, and that these are being made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Any statements contained in this call that relate to expectations or predictions of future events, results, or performance are forward-looking statements. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements.

Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the risk factors section of our public filings with the Securities Exchange Commission, including our quarterly report on Form 10-Q filed with the SEC on August 5, 2025.

This conference call contains time sensitive information and is accurate only as the live broadcast today, November '4, 2025. Cybell disclaims any intention or obligation, except as required by law to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise.

With that, I'll turn the call over to Jane.

Thanks, Brian. Good afternoon and thank you all for joining us for our third quarter 2025 earnings call.

I'm very pleased to report on another strong quarter as we continue to execute on our key growth initiatives while solidifying our position as the category leader in the point of care EEG.

We have continued to expand patient access to new account growth and increase the utilization while advancing our robust product pipeline.

We believe the strength of these initiatives is clearly reflected in our results. Total revenue for the third quarter of 2025 was $22.6 million. This reflects 31% growth over the same period last year and marks our 30th consecutive quarter of sequential revenue growth.

Our performance is the result of the predictable recurring nature of our business model and continued excellence in commercial execution to launch new accounts and drive increased usage.

Given these trends and momentum we build exiting the quarter, we remain confident in our core commercial strategy, and we are raising our four year 2025 revenue guidance.

We now expect to deliver $87 million to $89 million in revenue for the full year 2025, which represents 34% year over year growth at the midpoint.

Our success to date reflects not only strong commercial execution, but also the foundational work we have done to unlock what we believe to be an immediately addressable $2 billion dollar market opportunity.

Our primary focus is on establishing point of care EEG as a new standard of care for seizure management in the acute care setting.

We believe that every ICU and emergency department should have access to the cereal system and the benefits our solution provides. The need is both urgent and profound.

There are roughly 3 million patients in the US at risk for seizures in acute care setting. Many of these patients will face long delays in diagnosis with conventional EEG, spending hours or even days.

Others may never receive monitoring at all due to limited access to EEG or lack of clinical awareness.

The consequences are significant, as prolonged and untreated seizures can lead to severe and permanent brain damage or even death. Comparatively, the safer EEG clinical trial has shown that the cerebral system reduces the medium time to EEG by 19 hours, while reducing patients' severe disability rate by 18%.

At the same time, patients who are treated with anti-seizure medication without EED confirming seizures based on observation alone may be exposed to unnecessary risks, including intubation and extended ICU stays.

The cerebell system has been shown to enable a medium reduction in ICU length of stay by 4.1 days. Ultimately, patients' lives and their quality of life are on the line, and we believe our platform can enable more timely and appropriate care.

Helping these patients receive the care they need, starts with working to make the the bus system available to hospitals across the US.

To this end, we have steadily made strong progress in expanding our account base. As of September 30, we had 615 active accounts. This marks an increase of 35 accounts over the prior quarter, which is our largest sequential increase since becoming a public company.

In parallel, we continue to broaden our reach across additional sides of care.

As part of these efforts, we received Fed rent high authorization in the second quarter of this year, providing access to the nearly 200 hospitals within the VA system.

We are pleased to report that following a successful recent pilot, we have been informed that the VA system intends to expand the usage of the cereal system even further in the coming quarters.

As we expand into new facilities nationwide, we are also working with our current customers to drive usage and increase access across departments and patient populations. Our efforts to date have been successful, with utilization per account increasing nearly threefold over the past five years.

Still, we believe we are only 30% penetrated within our active account space, leaving substantial room for continued growth.

Our top performing accounts prove what's possible.

Usage within our TOP10% of accounts is roughly 3 times higher than in average accounts of similar size, and these top accounts are still growing. These high volume accounts maintain high rates of seizure detection, illustrating the sentiments that we hear from physicians. The more EEG you perform, the more seizures you find.

We aim to facilitate the replication and expansion of best practices used by these top accounts through continued training and education, clinical evidence generation, protocol development, and expansion to new departments, including the ED.

Our team is critical in leading this effort, which is well under the way.

Finally, beyond the adult population, we continue to invest in expanding access to pediatric and neonatal populations. Earlier this year, we received 510k clearance for clarity in pediatric population, making it the only seizure detection algorithm cleared for patients one year and older.

We are actively developing this market through an ongoing pilot of pediatric clarity within our existing accounts as well as children's hospitals with full launch anticipated next year.

Our confidence is backed by strong clinical data supporting our product.

Recently, in September. We are pleased to see the abstract documenting technical validation of pediatric clarity presented at the Neuro Critical Care Society annual meeting.

The retrospective study evaluated the performance of clarity in detecting suspected status epilepticus across 645 pediatric patients aged 1 to 17.

The results demonstrated a sensitivity of 94.4%, specificity of 93.1%, and a negative predicted value of 99.8%. These findings suggest that clarity can accurately monitor suspected status epilepticus in pediatric patients over one year old, providing timely and actionable guidance to bedside team.

With our AI-driven approach to product development, we expect these already excellent results to continue to improve as we build our database and continually refine our algorithms.

We also remain committed to expanding access to our system in the neonatal population, having already developed a head cap that meets the needs of this vulnerable patient group. We remain on track with the development of a neonatal application of clarity, which we anticipate to bring to market in 2026.

In the meantime, we have launched the multiple sites using the hardware without clarity and are conducting targeted market development efforts to better understand the nuances of the neonatal population.

These investments reinforce our mission to helping to establish point of care EEG as a new standard of care for seizure detection in the acute care setting, serving all patients everywhere.

We also estimated the addition of pediatric and neonate products could expand our current addressable market opportunity of $2 billion by approximately $400 million. We see a tremendous growth runway as we advance our mission.

We will continue to invest in evidence generation, product improvements, provider education, and the replication of the best practices from top performing centers.

Collectively, these investments combined with our established advantages give us great confidence in our ability to strengthen our reputation as the category leader and a trusted partner for rapid EEG and seizure detection and monitoring.

Before I turn it over to Scott, I want to also briefly touch on the second horizon of our vision, making EEG a new vital sign in acute care.

This requires developing a multi-modal system that can become a routine part of care for all patients at risk of a range of neurological abnormalities.

We plan to achieve this by expanding our detection capabilities into new conditions such as delirium and stroke.

Our nearest term area of focus for innovation is advancement of our delirium algorithm. We are pleased to be able to say we remain firmly on track with our development timeline.

As a reminder, this is a market where there is no commercially available diagnostic device, despite delirium being a pervasive and challenging condition that affects over 30% of patients in the ICU.

We are thrilled with our progress to date and expect to detail a more comprehensive vision for the opportunity and our associated commercial strategy in the coming quarters.

It is important to note that our excitement around potential new indications such as delirium is directly connected to our mission to help establish point of care EEG as the standard of care.

Broad adoption of the Sabo system across our market for seizure detection gives us the in stock base data, trust, contractual relationships, security clearances, and the sales infrastructure to rapidly develop and deploy new algorithms.

We believe these new algorithms will significantly expand our total addressable market by introducing much needed solutions for new patient populations. We anticipate that we will also create synergistic value by allowing concurrent monitoring for patients at risk of multiple overlapping conditions.

As a result, in addition to providing access to new patients, these pipeline products are expected to directly drive utilization within our install base. We expect they will serve as a strong growth engine for years to come, while largely leveraging our existing self infrastructure.

To summarize, I'm incredibly proud of what we have achieved this quarter.

Over 600 hospitals have adopted Cerreel, and our team is making meaningful progress in penetrating deeper within these accounts. And still, we remain very early in our journey to establish point of care EEG as standard of care in the $2 billion US seizure detection market.

We are currently used by roughly 10% of the hospitals that provide acute care service in the US. This means that there are still over 5,000 hospitals that do not have a point of care EEG solution that we believe could benefit from our technology.

Within the customers that we do serve, we estimate we are only about 30% penetrated for patients who need timely seizure detection. Taken together, this suggests that we are only about 3% penetrated into our core market in the US.

We aim to go deeper and wider to address the unmet needs of the remaining 97%, both through ongoing commercial efforts and by making investments in extending the life changing benefits of the cereal system to additional patient populations.

This includes monitoring neonatal and pediatric patients, which represents an incremental market opportunity of approximately $400 million as soon as next year.

In parallel, we are working to go beyond seizure. We have made real progress in unlocking delirium and strokes. We believe that these indications represent a multi-billion dollar market expansion opportunity and serve as the foundation of our mission of making EEG a new vital sign.

With that, I will now turn the call over to Scott Blumberg, our CFO, to provide a review of our third quarter results and outlook for the remainder of 2025.

Thank you, Jane, and good afternoon, everyone.

As Jane highlighted, total revenue for the third quarter of 2025 was $22.6 million a 31% increase from $17.2 million in the third quarter of 2024. The increase is primarily driven by increased adoption of the Sariel system across new and existing accounts.

Product revenue for the third quarter of 2025 was $170 million representing an increase of 28% from $13.3 million in the third quarter of 2024. Subscription revenue for the third quarter of 2025 was $5.6 million representing an increase of 44% from $3.9 million in the third quarter of 2024.

In Q3, we continue to drive deeper into our accounts, increasing usage per account year over year. This was achieved despite abnormally high purchases relative to usage in Q3 2024, which led to excess product revenue during the comparison period.

As a reminder, we typically see reduced usage in Q2 and Q3 relative to Q1 and Q4, driven by lower IU centers in the summer months. Gross margin for the third quarter of 2025 was 88% compared to 87% in the prior year period.

As we enter Q4, I'll remind you that we will begin to transition to utilize an inventory acquired after the implementation of increased tariffs on products originating in China.

Despite this, we expect to maintain gross margins in the mid 80% range in Q4. As we reported last quarter, we took proactive steps this year to establish an additional manufacturing line in Vietnam, which is now fully operational.

This reduces our exposure to China-based tariffs and positions us to benefit from potentially more favorable trade policies.

Looking ahead, we believe initiatives undertaken this year to strengthen our supply chain and build resilience, put us on track to deliver gross margins in the mid 80% range for full year 2026, assuming no changes to the currently proposed tariffs.

Total operating expenses for the third quarter of 2025 were $34.6 million an increase of 39% compared to $24.9 million in the third quarter of 2024.

On cash stock-based compensation expense was $3.3 million in the third quarter of 2025.

The increase in operating expense was primarily attributable to investment in our commercial organization. Increase had account to support growth of the business, legal expenses, and expenses related to operating as a public company.

Sales and marketing expenses increased $1.1 million in Q3 compared to Q2.

The sequential increase was driven by salary and commission expenses associated with headcount expansion in Q3, as well as full quarter impact with headcount additions from Q2.

Net loss was $13.5 million for the third quarter of 2025 or a loss of $0.37 per share compared to a loss of $10.4 million or loss of $1.85 per share in the third quarter of 2024.

An average weight to share account of 36.8 million shares is used to determine loss per share for the third quarter of 2025. Our cash equivalent and marketable securities as of September 30, 2025 were $168.5 million.

Earlier today, we filed a shelf registration statement on Form S3 with the SEC as we recently became eligible to do so following the one year anniversary of our IPO.

This is strictly a matter of standard corporate housekeeping as it allows us to maintain flexibility, but to be clear, we do not have any intention to pursue a financing transaction at this time.

We remain committed to achieving cash flow break even with cash on hand, and the strength of our balance sheet gives us a high degree of confidence that we can achieve this without raising additional capital.

Turning now to our outlet for the remainder of 2025.

Given our momentum in the third quarter of 2025, we now expect full year 2025 revenue to range from $87 million to $89 million up from our prior guidance of $85 million to $88 million which represents annual growth of 33% to 36% over 2024.

We continue to add to our base of active accounts and have an extremely healthy backlog of accounts that have issued purchase orders to adopt a terrible system.

While we do not provide guidance on our account base, it's worth noting that we intend to continue the practice we began in 2023, in which we defer launching new accounts in the second half of December.

This approach is grounded in our historical experience that the better to avoid launching during the holidays.

As we've seen that uninterrupted attention to a high-quality launch is necessary to maximize usage during the first few weeks following launch, which we believe is critical to establishing healthy long-term utilization rates.

With that, I'll turn the call back to Jane.

Thank you, Scott, and thank you all for your time today. In conclusion, I am very pleased with our 3rd quarter performance and our team's ability to continuously advance initiatives that will enable us to realize our broader strategic vision.

I'd like to thank our employees, our customers, and the patients we serve for enabling us to continue our mission to help save lives while delivering substantial values to our stakeholders.

Finally, we appreciate your support and continued interest in Farebel.

We look forward to providing you with updates on our progress in the quarters to come.

I will now turn the call over to the operator for any Q&A operator.

This will now start the question-and-answer session. In order to ask a question, press start and one on your telephone keypad. Just give me one moment to compile the Q&A roster.

Your first question comes from the line of Travis Steed from Bank of America. Your line is live.

Hey, congrats everybody. Maybe start with just on on 2026 and curious if you have any early thoughts at this stage, thinking about account ads and utilization and and and pricing, especially with the endAP expiring for next year.

I can take the Travis. We're not providing commentary on 2026. We'll of course provide guidance in the coming call. I think the fundamentals of the business and the sources of growth in terms of adding new accounts and driving usage will remain our consistent drivers as it relates to price.

We've seen a very high degree of consistency in pricing in our in our headband this year. We've seen an increase in the clarity ASP as we've driven more recorders into existing sites and expect to maintain strong discipline as we think about pricing going forward.

Okay, that's that's fair. And then maybe a question on the neonatal opportunity.

I appreciate all the information on the call, but when you think about launching that, maybe just provide a little more color on how the full launch looks for that in 206 and do you need to add new accounts that are accounts or do you go deeper in your own accounts so you can go faster?

Just just trying to think about how that actually launches and rolls out.

Yeah, so the short answer is both, in terms of open new accounts, through neonatal as well as existing accounts. Out of the about 850 level three and number four NICUs in the country.

Our existing install base represent roughly 200 NIUs already. So for those 200 NICUs, that would be more a departmental expansion. So we put that more under the growth category of same store growth driving utilization.

Outside that there are two different market segments. One is the other 280 children's hospital. We currently are barely presented in the Children's Hospital, not surprisingly because our product is very adult focused, so that present more new account acquisition.

Even the Young Children's Hospital, we have initially seen. Strong interest from IQ, through a especially level three community hospital, often have to transfer patients out for lack of EEG. So we also anticipate that NIU can drive new account addition due to strong support from NICU.

Great. Thanks a lot.

Thank you, Chavis.

Your next question comes from the line of Robbie Marcus from JP Morgan. Your line is live.

Oh great, good afternoon and congrats on a nice quarter.

12 for me, first.

Really want to ask on just the progress you're making and penetrating accounts educating the different components of the hospital and I know last year you you spent a lot of time in focus building the model to make sure that new accounts ramp up in a consistent and sustainable manner and just your your progress there and and the traction you're getting.

Yeah, I would say the success there is a continuation of we have seen historically, as you can see, we continue not just driving account acquisition but also utilization.

Specifically this year we rolled out a few initiatives that we have been seeing success.

One is, as Scott mentioned briefly, that we start to encourage the team successfully to bring more additional recorders to existing accounts that often is leading to additional departments. Using our device so we can see very strong correlation between growth and those initiatives.

The second initiative we rolled out, we start seeing impact in this year and we anticipate seeing even more impact next year is partnered with the physicians on protocolization outpatient population.

We especially seen success of that with cardiac arrest or post hemorrhagic stroke, which are clearly recommended by the guideline as hospitals do not always update their guideline every quarter is often, every year, so as we can, we anticipate next year, we'll see continued growth there.

The other initiative more surround more is about building on continued education. To physicians as well as nurses also continue quarterly engagement to the administrator to not just theoretically show the economical values that will bring, but using their own clinical data to show the economical value.

Great, maybe one on expenses. You're selling and marketing and R&D as per the guidance came in above the revenue growth.

I respect you'll comment on 2026 on the fourth quarter earnings call, but how are you thinking about revenue versus OpEx growth in the short and medium term, and how do you feel about your progress towards cash flow break even?

Thanks.

A lot.

Yeah, I think we came into this year with successful IPO raising more than we intended, and a big portion of that proceed was invested in expanding the commercial infrastructure.

The nature of our model is that there's a delayed impact and so the the nature of the relationship between sales and marketing growth this year and revenue is a reflection of that. The the investment comes ahead of the outcomes.

Of course we'll continue to look for opportunities to grow, but our current thinking. At least on the account acquisition side, the size of expansion we saw over the last year would probably be less in the coming year. And so I'd expect the growth to moderate there a bit and the investments that we made this year should start to generate impact as we get into 2026 here.

As far as cash goes, with an 88% gross margin and pretty strong control over our investment, which is tied almost entirely to growth and very little to maintenance, we have the flexibility to continually adapt our investment strategy to ensure that we always stay safe in terms of sufficient cash cushion.

Appreciate it thanks a lot.

Thank you, Robbie.

Your next question comes from the line.

Of Brandon Vazquez from William Blair. Your line is live.

Hi everyone, thanks for taking the question. Can you start maybe by talking a little bit about utilization growth across accounts by 10 years, especially those that, you, you've been talking about some of these initiatives to establish protocols at the accounts where patients per ID guidelines should be getting EEGs.

Are those kind of older, more tenure accounts continuously growing in utilization? Just kind of curious. The question is more around your more tenured accounts. Has utilization growth been pretty consistent just to know if that's a good signal for growth going forward as your new accounts ramp.

Yeah.

Thank you, Brandon. .

There are quite a few.

Drivers under the growth we've seen from more tiny or top accounts, and we see many of these drivers would continue driving both top or just all the rest of the accounts. The number one driver is what you already. Articulated, which is the external guidelines.

The stroke seizure management for the stroke population guideline came out in 2022 and 2023. The cardiac guideline came out end of 2019.

And so, and then there's COVID, so there's quite a few, many hospitals still are not fully adopted to this guideline yet. For our top account growth, we often just see the hospital start to over time rolling out one protocol over another.

First cardiac arrest, then you know ICH patient. So that's a continuous driver. And even our top accounts, I would say not every single population group are fully on protocol yet. That's why we anticipate to see the continuous growth there.

The second driver is the departmental expansion. Even our most tenured accounts or our top usage accounts are not in every single department yet. They might be in all the ICUs and ED, but they might not be in the step down units or or in the on the floor with an open rapid response nursing team yet.

And of course as we start to launch pediatric and neonate, there will be further departmental ex expansion.

The third driver, I would say is more driven by our internal execution. We realize not every providers are trained even though they might miss the initial training during the site initiation turnover, especially during the night shifts.

So our, camping and really put a lot of effort. Above and beyond and go late hours to train the night shifts and that's not 100% done yet. So those are some examples probably the top drivers that we've seen how our tenured accounts growing and we see these accounts, these drivers it's not applicable just to tenured accounts, but all our.

Accounts.

Okay, great. And then as a follow-up to that, I think Jane you're just kind of alluding to this, but you made an interesting comment on the prepared remarks that only 30% of account or in your current accounts you're only 30% adopted rather. Is going further into your current accounts driven a lot in putting these protocols and then I think like you said, going into new wings like how do you do that?

What is the friction point of getting into these new wings and then one unrelated follow-up if I could just throw in there late last week I think you guys got a new 510-K clearance on the head cap. Any comments on the importance of that clearance.

Thank you.

Yeah.

I mean, in terms of going to departmental expansion and protocolization, a majority of it is really execution.

I think if we think about what are the potential barriers is both the resource on our end as well as often the resource on the or the priority on the hospital end.

And sometimes rolling out a new protocol is beyond the capacity of the nursing team or it's currently they have other priority, for instance, they are updating their API system, so those are some practical barriers we run into, but we believe that over time because of the strong guideline recommendation and its clinical value and evidence will continue to generate, we should overcome those.

Those barriers. In terms of the 510-k head cap, I think you are referring to the neonatal and head cap. The main clearance we have there compared to the previous neonate head cap is that the previous version we have the label of approved for all ages, and during our pilot we learned that our physicians and nurses would like the FDA clearance to be even more.

Specific that is cleared for preterm as well as term neonate because they are very protective of this vulnerable population. So our current latest head cap is cleared for both preterm as well as term neonatal population.

So this is actually a great manifestation. Sample of our strategy as we do pilot, we actually learn things that we didn't anticipate as we rolled out the product. So we see this recently approved or cleared head cap would be the product that will be ready for full commercialization as we receive the clearance of neonatal clarity.

Your next question comes from the line of Josh Jennings from TD Cowan. Your line is live.

Hi, good afternoon. Thanks for taking the questions and congratulations on another strong quarter.

I think Jane, you've caught out that cerebellar point of care EEG is kind of penetrated in about 10% of US acute care hospitals. The word of mouth, but according to our checks from the customer base is getting louder and buzz is getting stronger.

The library of clinical evidence and and the cost effective data is growing. I was hoping. To just maybe that that intro into the question of, okay, can you add some quantitative or qualitative color just on where the new customer account pipeline or funnel sits today relative to the beginning of the year and just in terms of giving us up thinking about the potential for account growth in 2026.

Yeah, Josh the numbers that are reflected in our active account based is launched accounts, which is when the customer is fully trained in live.

Of course we measure before that we measured when we receive a purchase order, we measure the various stages of engagement that happen that lead to a purchase order without getting quantitative on it, I can tell you that that number, the funnel is growing and it's growing as a direct reflection of both of the investments we've made.

In our commercial or over the past year, but also I believe the appreciation of the need for this technology that's growing by the day.

And I just was hoping to better understand how our positioned with with IDNs or healthcare systems and have, has the company benefited from Some IBMs kind of making best practices decisions or standard of care within their within their network.

Or is that opportunity in front of Cerebell maybe just help us think about how you're positioned to the number of IDMs that are in play in the United States. Thanks for taking the questions.

Thank you, Josh.

Yeah, we definitely have seen that the partnership with hospital systems has been a strong growth engine, from previous years, including the current one. And we see potentially even bigger opportunity ahead of us.

I think historically, especially a few years back when we were much smaller, we often do not engage IBM at the headquarters level because we were so small. We were more engaging at the individual hospital level as we becoming available in 600 plus hospitals in the US, we are building our hospital system.

Sales team and also the entire sales team between our entire sales team to not only thinking about individual hospital but really thinking about hospital system level sales. So that requires we call it the bottom up and top down sales coordination.

We more just started doing this systematically this year, so we anticipate continue executing and capture the opportunity here become even better partner for our.

Customers.

Understood. Thanks, Scott.

Thank you, Josh.

Your next question comes from the line of Bill Palog-Vanik from CanCore Genuity. Your line is live.

Hey, great, thanks, and you did a good job on the pronunciation. So, start out with first just, I'm looking at the guidance and it's pretty broad, low end is about I think 23% year over year, high ends 25% or 35% year over year, multiple questions here.

First what drives the lower end versus the higher end of that. I mean, it's a pretty broad guidance range considering you're coming into the end of the year. I'm going to start with that and then multiple other.

Yeah.

I think our philosophy and guidance remains unchanged. We appreciate the importance, especially as a company that's only been public for a year, to put forth numbers that we feel very strongly we're able to achieve and that colors the way we think about guidance.

So when there's things that we know or believe like, Q4 seasonality, for example, being stronger than Q3. As we think about the bottom of the range, we think about, being extremely conservative and essentially de-risking all the unknown.

So, I think it's, I would read into the range really as risk calibration and us putting forth numbers that we have a very high degree of confidence in.

Okay, and then I just want to, post IPO, one of the things you did was you took a lot of that you invest in the sales force should any update on where you are with the TMs and the camps today and then.

You saw an uptick, I think, basically 31 new active accounts sequentially, that's the highest number we've seen in a very long time. It's definitely ticking up.

Just, is this a function of the new reps that were brought on kind of what are the drivers of that this quarter?

As far as the commercial infrastructure goes, we haven't made any fundamental changes to our strategy since last quarter. We still have roughly the same number of territories planned in the mid-50s right now on the TM side.

We have and we'll continue to invest in the CAM side of the business because that side of the org grows roughly in line with the growth of the account base, so we're fully staffed. On that side, but that will continue to grow.

I think we also are looking opportunistically at areas to invest to accelerate further growth and Jane's answer to a prior question, I think is one area where we're looking very closely, which is, IDN level systems.

31. 0, as far as as far as the account ads go, we're obviously very pleased with the results this quarter. I know there's a lot of kind of emotional difference between the 29 we did last quarter, a couple of quarters ago and 31, but I consider that largely in the kind of range of expected outcomes here and we fully expected that the hires we make start to become productive as we get into the 26 here.

Okay, and then, I think Robbie asked the question, you've been growing revenue pretty strong. We haven't seen leverage in the P&L, and I think one of the questions we get from investors is that something we're like, I know you haven't given guidance yet, but is there a reason we won't start seeing it sometime in the next year?

The only reason you would expect, I expect us not to see it is if we make a strategic decision because we see a profound growth opportunity to really invest in the ops to capture that growth, and if and when we make that decision, we'll communicate that clearly to the streets so that it's not a surprise.

Okay, and then, any update just on competition? The other question we get a lot of is just competition. What are you seeing in the marketplace? Are you losing any more accounts today or winning any more, versus where you were six or 12 months ago? And then any update on the IP litigation? What are the next.

Steps?

Yeah.

On the competition front, I think Q1 Q2, we saw a significant increase of the competition activity as we mentioned before. In Q3, I would say there's nothing substantial change. We see continued growth of competition activities there. However, I would say our performance in 2025 speaks for itself.

We have be and raised our guidance every single quarter, and that shows that the competition is not meaningfully impact our performance, and the reason we are. Achieving this is not only leveraging the superiority of our product, clinical evidence, and cybersecurity. We are also learning a lot about competition and put, strategy and plan in execution to address this.

And in terms of ITC litigation as Investors, so you'll probably see ITC have outlined the milestones before the shutdown at the time the anticipated decision in September next year and this final ruling of January 2027. With the government shutdown, we anticipate some level of delay there, then we also expect that ITC would update the timeline as soon as the government reopens.

Okay, and then just last for me, I think you mentioned the shift to Vietnam with the manufacturing. We'll start to see the impact in Q4. I think you mentioned, that'll drive mid 80s gross margin.

Is 100% of that into the quarter or is it kind of where we'll see margins ramped down this year in Q4 and then hit that mid 80s for next year? How do we think about kind of cadence there? Thanks for taking my questions.

Sure. So Q4 will be relying for the first part of the quarter on pre-tariff inventory and then for the remainder of the quarter only on China inventory because it's essentially inventory that was acquired before we had Yanom running so.

Vietnam doesn't impact this quarter as we as we move into next year, what you'll see is China inventory that we've acquired at a higher tariff rate mixed in with Vietnam inventory at a lower tariff rate currently, and that that should reflect itself in that continuation of the mid 80% gross margin into next year.

Your next question comes from the line of Jeffrey Cohen from Thalmann & Co.

Hi Scott, thanks for taking the questions.

First, I wondered if you could dive into the VA channel a bit more and talk about some of the the current accounts and some of the expanded accounts and what you may expect, how that applies into our 4th quarter next year as far as the growth specific to VA.

Yeah, so we.

Do not, even though we cannot and do not disclose the specific numbers on VA or specific hospital system. But I'm really excited and can talk more about what we can share about VA. So VA has a very rigorous process, in terms of piloting first and then systematically roll out, at different phases.

So where we are now is the first few pilots have been very successful, both the physicians. And administrators at the VA clearly not only saw and also experienced the value our system delivers clinically as well as financially, so we are now confirmed to roll out the first larger cohort of VA accounts in the next couple of quarters.

And so this will be one of the largest top down rollouts we've ever done in the in the history. So that's what we're very excited about. It's is not only a big win for the company, but also for the veterans, who we serve, who are at the risk of seizures.

Okay, got it. And then as a follow-up I know you spoke previously about the the head cap and neonatals, but you made a comment about the utilization of hardware without clarity that was happening in Q3. Could you just expand upon that a little bit for us, please?

Yeah.

We, it's a premature to probably talk about utilization at the account level for Leon it at this space yet because the pilot we focus on is, really on the population discussion confirming signal quality and confirming either. Use because of the nature of that, it does not perfectly reflect what will be the actual commercial clinical usage.

However, what we can report is it has been very well received.

We already have certain case studies that the physicians and nurses.

Said it significantly helped the patient either detecting seizure early or avoid unnecessary medication for the patients which is critical for patients' outcome.

So we are excited to potentially bring the entire product from hardware with clarity to market in 2026.

Okay, perfect. Thanks for taking our questions.

Thank you, Jack.

The final question comes from the line of Jayson Bedford from Raymond James Financial Inc. The line is live.

Hi, this is Elaine on for Jason. Thanks for taking the question.

So by our map, you grew utilization year over year despite the tough com from stocking in 3,224. So I was just wondering how much would utilization have grown, excluding the stocking impact and also did you see the usual seasonality impact this quarter as well?

The quarter, year over year growth comparison would have looked much more similar to the year over year growth we saw in Q1 and Q2, had there not been, the purchases in Q3.

As far as seasonality goes, yes, of course, we'll know for sure after we get through Q4, but If you look kind of sequentially, the, Q1 was really strong and Q2 and Q3 on a sequential basis were less so, and that's been, exactly consistent with what we've seen in the last two years.

And we're still obviously only a few years in this commercial journey, but this year has not surprised us in any way in terms of the quarter to quarter trends.

Thank you. And for my follow-up, I was wondering, could you share more sorry, more color on the utilization trends?

Are certain departments driving the increased utilization? Are you seeing more in the ICU or the ED, for instance, and I know we talked a little bit about the use cases.

Yeah.

Overall, we, actually see a relatively broad growth drivers, so from departmental expansion to protocolization. And even beyond the ICU and ED to the floor to the step down units, and particularly we do see a bit strong.

Even stronger growth in the emergency department compared to the ICU because EDs are in general even less penetrated and so that's why overall, but we don't see a single driver that accounts for majority of the growth.

And that concludes the question-and-answer session. I'd now like to turn the call back over to Jane Chow for closing remarks.

Thank you. Well, thank you everyone for your attention and for joining the call. Again, we are very excited and proud of what we have accomplished for Q3 and look forward to sharing our performance of next quarter and quarters to come.

Thank you.

This concludes the meeting you may now disconnect.