CeriBell - Earnings Call - Q3 2025

Executive Summary

• Q3 revenue was $22.6M (+31% YoY) with 88% gross margin; FY25 revenue guidance raised to $87–$89M (midpoint +$1.5M vs prior). Consensus revenue was $21.78M*, and GAAP EPS was -$0.37 vs consensus -$0.41*, both better than expected.
• Active accounts reached 615 (+31 sequential, largest quarterly add since IPO), supported by VA pilots and FedRAMP High authorization; utilization continues to expand across departments and patient groups.
• Management flagged tariff-driven margin compression in Q4 but expects mid-80% gross margin as mitigation (Vietnam line) ramps; reiterated supply chain resilience and cash sufficiency toward cash flow breakeven.
• Guidance raised for the third consecutive quarter; catalysts include VA system rollout, pediatric Clarity expansion in 2026, and delirium algorithm development (no device competitors today).
• Risks: OpEx up 39% YoY, ongoing losses (-$13.5M), rising competitive activity, and IP litigation timing uncertainty post-government shutdown.

What Went Well and What Went Wrong

What Went Well

• Strong top-line and recurring momentum: revenue $22.6M (+31% YoY), GM 88%, subscription revenue +44% YoY; largest sequential account adds (+31) since IPO.
• Guidance raised again: FY25 revenue to $87–$89M; management emphasized durable adoption and predictable recurring model.
• Strategic pipeline and channel progress: VA pilots successful with top-down rollout ahead; pediatric Clarity validated (sensitivity 94.4%, specificity 93.1%, NPV 99.8%) and neonatal headcap clearance refined for preterm/term neonates.

What Went Wrong

• Continued operating losses and higher OpEx: OpEx rose to $34.6M (+39% YoY); net loss -$13.5M; sales & marketing up sequentially on headcount expansion.
• Tariff headwinds: transition to post-tariff China inventory in Q4 likely compresses GM to mid-80% short term; Vietnam line won’t offset until next year.
• Competitive intensity and IP uncertainty: increased competitor activity, with ITC decision timeline pushed back due to government shutdown; elevated legal costs.

Transcript

Operator (participant)

Good afternoon, and thank you all for participating in today's call. Joining me from Ceribell 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 30th, 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 and Exchange Commission, including our quarterly report on Form 10-Q filed with the SEC on August 5th, 2025. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, November 4th, 2025. Ceribell 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.

Jane Chao (CEO)

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 through 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 built exiting the quarter, we remain confident in our core commercial strategy, and we are raising our full year 2025 revenue guidance. We now expect to deliver $87 million-$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 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 Ceribell system and the benefits our solution provides. The need is both urgent and profound. There are roughly 3 million patients in the U.S.

at risk for seizures in the 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 Ceribell system reduces the median 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 EEG confirming seizures based on observation alone may be exposed to unnecessary risks, including intubation and extended ICU stays. The Ceribell system has been shown to enable a median 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 Ceribell system available to hospitals across the U.S. To this end, we have steadily made strong progress in expanding our account base. As of September 30th, we had 615 active accounts. This marks an increase of 31 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 sites of care. As part of these efforts, we received FedRAMP 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 Ceribell 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 base, leaving substantial room for continued growth. Our top-performing accounts prove what's possible. Usage within our top 10% accounts is roughly three 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 sentiment 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 CAM team is critical in leading this effort, which is well-underway. Finally, beyond the adult population, we continue to invest in expanding access to pediatric and neonatal populations. Earlier this year, we received 510(k) clearance for Clarity in pediatric population, making the only seizure detection algorithm cleared for patients one year and older. We're 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 an abstract documenting technical validation of pediatric Clarity presented at the NeuroCritical Care Society annual meeting. The retrospective study evaluated the performance of Clarity in detecting suspected status epilepticus across 645 pediatric patients aged 1-17. The results demonstrated a sensitivity of 94.4%, specificity of 93.1%, and a negative predictive 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 headcap 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 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 help 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 neonatal 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 the advancement of our delirium algorithm.

We're 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% 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's 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 Ceribell system across our market for seizure detection gives us the installed 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 installed base. We expect they will serve as a strong growth engine for years to come, while largely leveraging our existing sales infrastructure. To summarize, I'm incredibly proud of what we have achieved this quarter. Over 600 hospitals have adopted Ceribell, 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 U.S. seizure detection market.

We're currently used by roughly 10% of the hospitals that provide acute care service in the U.S. 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're only about 3% penetrated into our core market in the U.S. We aim to go deeper and wider to address these unmet needs of the remaining 97%, both through ongoing commercial efforts and by making investments in extending the life-changing benefits of the Ceribell 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.

Scott Blumberg (CFO)

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 Ceribell system across new and existing accounts. Product revenue for the third quarter of 2025 was $17 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 continued 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 ICU census 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 utilizing 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. Non-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, increased headcount 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 of 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 a loss of $1.85 per share in the third quarter of 2024. An average weighted share count of 36.8 million shares was used to determine loss per share for the third quarter of 2025. Our cash, cash equivalents, and marketable securities as of September 30th, 2025, were $168.5 million.

Earlier today, we filed a shelf registration statement on Form S-3 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 outlook 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-$89 million, up from our prior guidance of $85 million-$88 million, which represents annual growth of 33%-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 the Ceribell 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 it's 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.

Jane Chao (CEO)

Thank you, Scott, and thank you all for your time today.

In conclusion, I'm very pleased with our third-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 Ceribell. 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 star 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.

Travis Steed (Managing Director)

Hey, congrats, everybody.

Maybe to start with just on kind of 2026, I'm curious if you have any early thoughts at this stage in thinking about account adds and utilization and pricing, especially with the end cap expiring for next year.

Scott Blumberg (CFO)

I can take that. Hey, 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 pricing, we've seen a very high degree of consistency in pricing 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.

Travis Steed (Managing Director)

Okay. 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 2026. And do you need to add new accounts that are neonatal accounts, or do you want to go deeper in your own accounts so you can go faster? Just trying to think about how that actually launches and rolls out.

Jane Chao (CEO)

Yeah. So the short answer is both in terms of opening new accounts through neonatal as well as existing accounts. Out of the about 850 level three and level four NICUs in the country, our existing installed base represents roughly 200 NICUs 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. The 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 represents more new account acquisition. Even beyond children's hospital, we have initially seen strong interest from NICU. Through a specialty level three community hospital, often have to transfer patients out for lack of EEG. So we also anticipate that NICU can drive new account addition due to strong support from NICU.

Travis Steed (Managing Director)

Okay. Great. Thanks a lot.

Jane Chao (CEO)

Thank you, Travis.

Operator (participant)

Your next question comes from the line of Robby Marcus from JPMorgan. Your line is live.

Robby Marcus (Medtech Senior Analyst)

Oh, great. Good afternoon and congrats on a nice quarter. Two for me. First. Really want to ask on just the progress you're making in penetrating accounts, educating the different components of the hospital.

And I know last year you spent a lot of time and focus building the model to make sure that new accounts ramp up in a consistent and sustainable manner. And just your progress there and the traction you're getting.

Jane Chao (CEO)

Yeah. I would say success there is a continuation of what 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 partner with physicians on protocolization of patient population. We especially see 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, it's often every year. So as we anticipate next year, we'll see continued growth there. The other initiative more surrounding 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 economic value Ceribell brings, but using their own clinical data to show the economic value.

Robby Marcus (Medtech Senior Analyst)

Great. Maybe one on expenses. Your selling and marketing and R&D as per the guidance came in above the revenue growth.

I expect 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.

Scott Blumberg (CFO)

Yeah. 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 kind of the nature of the relationship between sales and marketing growth this year and revenue is a reflection of that, that 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, is that 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've 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.

Robby Marcus (Medtech Senior Analyst)

Appreciate it. Thanks a lot.

Jane Chao (CEO)

Thank you, Robby.

Operator (participant)

Your next question comes from the line of Brandon Vasquez from William Blair. Your line is live.

Brandon Vazquez (Equity Research Analyst)

Hi, everyone. Thanks for taking the question.

Can you start maybe by talking a little bit about utilization growth across accounts by tenure, especially those that you've been talking about some of these initiatives to establish protocols at the accounts where patients per society 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.

Jane Chao (CEO)

Yes. Thank you, Brandon. There are quite a few drivers under the growth we've seen from more tenured 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 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 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 EDs, but they might not be in the step-down units or on the floor with an open rapid response nursing team yet. And of course, as we start to launch pediatric and neonatal, there will be further departmental expansion. The third driver, I would say, is more driven by our internal execution. We realize not every provider is trained, even though they might miss the initial training during the site initiation turnover, especially during the night shifts. So our CAM team 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 are growing. And we see these drivers are not applicable just to tenured accounts, but all our accounts.

Brandon Vazquez (Equity Research Analyst)

Okay. Great.

And then as a follow-up to that, I think, Jane, you were just kind of alluding to this, but you made an interesting comment on the prepared remarks that only 30% of accounts 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. 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 headcap. Any comments on the importance of that clearance? Thank you.

Jane Chao (CEO)

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, it's both the resource on our end as well as often the resource on the other priority on the hospital end. And sometimes rolling out a new protocol is beyond the capacity of the nursing team. Or currently, they have other priorities. For instance, they are updating their Epic system. So those are some practical barriers we run into. But we believe that over time, because of the strong guideline recommendation and there's clinical value and evidence we'll continue to generate, we should overcome those barriers. In terms of the 510(k) headcap, I think you are referring to the neonatal headcap. The main clearance we have there compared to the previous neonatal headcap is that the previous version we have the label of cleared for all ages.

And during our pilot, we learned that our physicians and nurses would like the FDA clearance to be even more specific about it's cleared for preterm as well as term neonates because they are very protective of this vulnerable population. So our current, the latest headcap is cleared for both preterm as well as term neonatal population. So this is actually a great manifestation, example 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. The recently approved or cleared headcap would be the product that will be ready for full commercialization. As we receive the clearance of Neonatal Clarity.

Operator (participant)

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

Josh Jennings (Managing Director)

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

I think, Jane, you've called out that. Ceribell point-of-care EEG has kind of penetrated about 10% of U.S. acute care hospitals. The word of mouth, according to our checks from the customer base, is getting louder. Buzz is getting stronger in the library of clinical evidence. And the cost-effectiveness data is growing. I was hoping to just maybe leave that intro into a 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 help thinking about the potential for account growth in 2026.

Scott Blumberg (CFO)

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

Of course, before that, 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 org over the past year, but also, I believe the appreciation of the need for this technology that's growing by the day.

Josh Jennings (Managing Director)

And I just was hoping to better understand how Ceribell is positioned with IDNs or healthcare systems. And has the company benefited from some IDNs kind of making best practices decisions or standard of care within their network? Or is that opportunity in front of Ceribell? Maybe just help us think about how you're positioned through the number of IDNs that are in play in the United States.

Thanks for taking the questions.

Jane Chao (CEO)

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 an even bigger opportunity ahead of us. I think historically, especially a few years back when we were much smaller, we often do not engage IDN at the headquarter level because we were so small. We were more engaging at the individual hospital level. As we are becoming available in 600+ hospitals in the U.S., we are building our hospital system sales team and also train our entire sales team to not only think about individual hospitals, but really thinking about hospital system-level sales. So that requires what we call bottom-up and top-down sales coordination. We more just started doing this systematically this year.

So we anticipate continuing executing and capturing the opportunity here, becoming an even better partner for our customers.

Josh Jennings (Managing Director)

Understood. Thanks, Jane and Scott.

Jane Chao (CEO)

Thank you, Josh.

Operator (participant)

Your next question comes from the line of Bill Plovanic from Canaccord Genuity. Your line is live.

Bill Plovanic (Managing Director and Senior Equity Research Analyst)

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 end is 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 want to start with that and then multiple other.

Scott Blumberg (CFO)

Yeah. Bill, 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 unknowns. 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.

Bill Plovanic (Managing Director and Senior Equity Research Analyst)

Okay. And then I just want to. Post-IPO, one of the things you did was you took a lot of that and you invested in the sales force. Just any update on where you are with the TMs and the CAMs 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?

Scott Blumberg (CFO)

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 will 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. 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. Oh, as far as. The account adds go, we're obviously very pleased with the results this quarter. I know there's a lot of. Kind of immaterial difference between the 29 we did last quarter, a couple of quarters ago, and 31. But I'd 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 2026 here.

Bill Plovanic (Managing Director and Senior Equity Research Analyst)

Okay. And then. I think Robby 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.

Is that something where I know you haven't given guidance yet, but is there a reason we won't start seeing it sometime in the next year?

Scott Blumberg (CFO)

The only reason you would 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 OpEx to. Capture that growth. And if and when we make that decision, we'll communicate that clearly to the street so that it's not a surprise.

Bill Plovanic (Managing Director and Senior Equity Research Analyst)

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?

Jane Chao (CEO)

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. Been raising our guidance every single quarter. And that shows that the competition is not meaningfully impacting our performance. And the reason we're achieving this is not only leveraging the superiority of our product, clinical evidence. And cybersecurity. We are also learning a lot about competition and. Strategy and plan. In execution to address this. And in terms of. ITC. Litigation. As investors, you probably see ITC have outlined the milestones before the shutdown. And at the time, the anticipated decision is September next year and with final ruling of January 2027.

With the government shutdown, we anticipate some level of delay there. That we also expect that ITC would update the timeline as soon as. The government reopens.

Bill Plovanic (Managing Director and Senior Equity Research Analyst)

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 ramp down. This year in Q4 and then hit that mid-80s for next year? How do we think about kind of cadence there? And thanks for taking my questions.

Scott Blumberg (CFO)

Sure. So Q4, we'll 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's acquired before we have Vietnam up and running.

So Vietnam doesn't impact this quarter. 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 should reflect itself in that continuation of the mid-80% gross margin into next year.

Operator (participant)

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

Jeffrey Cohen (Director of Research)

Hi, Jane and 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 current accounts and some of the expanded accounts and what you may expect, how that implies into our fourth quarter and next year as far as the growth specific to VA.

Jane Chao (CEO)

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 Ceribell history. So that's what we are very excited about. It's just not only a big win for the company, but also for the veterans who we serve, who are at the risk of seizures.

Jeffrey Cohen (Director of Research)

Okay. Got it.

And then as a follow-up, I know you spoke previously about the headcap 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?

Jane Chao (CEO)

Yeah. It's premature to probably talk about utilization at the account level for neonate at this phase yet because the pilot we focus on is really on the population discussion, confirming signal quality, and confirming ease of 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 they significantly help the patient either detecting seizure early or avoid unnecessary medication for the patient, which is critical for patient's 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, Jeff.

Operator (participant)

Your final question comes from the line of Jayson Bedford from Raymond James. Their line is live.

Hi, this is Elaine on for Jason. Thanks for taking the question. So by our math, you grew utilization year-over-year despite the tough comp from stocking in 3Q24. 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?

Scott Blumberg (CFO)

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, the additional 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, 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 the last two years. And we're still obviously only a few years into 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 you talked a little bit about the use cases.

Jane Chao (CEO)

Yeah. Overall, we actually see relatively broad growth drivers. So from departmental expansion to protocolization.

And even beyond ICU and ED to the floor to the step-down units. And particularly, we do see a bit of even stronger growth in the emergency department compared to the ICU because EDs are, in general, even less penetrated. So that's why overall, but we don't see a single driver that accounts for the majority of the growth. Thank you.

Operator (participant)

That concludes the question and answer session. I'd now like to turn the call back over to Jane Chao for closing remarks.

Jane Chao (CEO)

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.

Operator (participant)

This concludes the meeting. You may now disconnect.