CeriBell, Inc.

Ladies and gentlemen, thank you for standing by. My name is Desiree, and I will be your conference operator today. At this time, I would like to welcome everyone to the Cerebo Q2 2025 earnings call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, again, press the star one. I would now like to turn the conference over to Brian Johnson. You may begin.

Good afternoon, and thank you all for participating in today's call. Joining me from Cerebel are Jane Chow, co-founder and chief executive officer, and Scott Bloomberg, chief financial officer. Earlier today, Cerebel issued a press release announcing financial results for the quarter ended June 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 10Q, filed with the SEC on May 8, 2025. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, August 5, 2025. Cerebel disclaims any intention or obligation, except as required by law, to update or revise any financial statements, projections, or forward-looking statements, whether because of new information, future events, or otherwise. And with that, I will now turn the call over to Jane.

Thanks, Brian. Good afternoon, and thank you all for joining us on our second quarter 2025 earnings call. Today, I will share key highlights from our second quarter results and review our progress towards our strategic priorities for 2025. John will then provide the overview of our financial performance and discuss our full-year 2025 guidance. I'm pleased to report that the total revenue for the second quarter of 2025 was $21.2 million. This reflects 38% growth over the same period last year. As of June 30, 2025, we had 584 active accounts, which translates to an increase of 26 active accounts during the second quarter. These results demonstrate our team's ability to efficiently launch new accounts and drive revenue growth, despite typical seasonal dynamics. As a reminder, we typically see reduced utilization in Q2 and Q3, as ICU census typically decreases in the summer months. Our core commercial strategy continues to be focused on driving account acquisition and increased utilization of the seizure detection system within our existing accounts. As we further expand our market presence, we continue to invest in our commercial infrastructure. We continue to target prospective accounts through our growing and increasingly tenuous team of territory managers. We're on track to achieve our target of expanding coverage to 55 territories by the end of this month. While we expect our overall territory account to remain relatively stable in the near term, we will continue to explore opportunistic investments for future growth through 2025 and beyond. Given the nature of our sales cycle, we anticipate that the territory manager additions over the past 12 months will begin to positively impact account acquisition growth in 2026. Meanwhile, we're continuing to invest in our clinical account managers to support launch and utilization expansion initiatives across our growing account space. Our second quarter performance has strengthened our conviction in the near and long-term growth trajectory. Given our momentum and the strength of our performance year to date, we're raising our full year 2025 revenue guidance. We now expect to deliver 2025 revenue of 85 to $88 million, which Scott will detail further in his remarks. Beyond investments in our direct sales organization, we're also advancing broader efforts to expand awareness of our novel technology. We are directly engaging with clinicians, investing in marketing initiatives, and importantly, generating further clinical and health economic evidence. While investments in this marketing and clinical initiatives are important, I truly believe the tangible real-world value our platform delivers will remain our most effective marketing tool. It is immensely powerful when a clinician witness the impact of Cerebell solution on the patient firsthand. We have previously shared stories where Cerebell systems prompt identification of stethes epilepticus saved lives. Today, I'd like to share a recent patient story that illustrates the value in demonstrating the absence of seizures, which is the even more common occurrence. In a recent case, an elderly woman in the Bay Area was unfortunately found unresponsive at the bus station and rushed to the emergency department of a local hospital. As her conditions remained unclear and seizure was suspected, the care team prepared to incubate her and admit her to the ICU. Just moments before proceeding, her care team applied the Cerebell system at the back side. Our -of-care EEG system continuously showed zero seizure burden, helping the care team to rule out seizure. The care team was able to determine that the patient was in the deep sleep, likely caused by a high dose of recreational drugs. With this information, the care team shifted its approach and focused on stimulation to wake the patient up. The patient regained consciousness within a few hours and was discharged without ever requiring ICU-level care. Without Cerebell, the care team may not have been able to diagnose the patient so quickly. Instead, the patient may have received unnecessary anti-seizure medication, potentially resulting in intubation and a prolonged ICU stay. This real-time data not only potentially changed the course of care for this patient, but also helped the broader care team avoid a cascade of unnecessary and costly interventions. As hospitals continue to emphasize expense management, we believe experience like this serve to cement the Cerebell value proposition in the minds of our users. Physicians trust Cerebell because it helps them provide better care for their patients. In addition, administrators value Cerebell because it can enable hospitals to substantially reduce costs, especially those associated with prolonged ICU stays. As we continue to invest in growing our commercial footprint, we are also advancing our mission to make the Cerebell seizure detection system available for even more patients. This includes our ongoing market development efforts and the pilot of clarity for pediatric patients following our 510K clearance in April. We are also making good progress with the neonate population in piloting our FDA-cleared hardware and in continuing to develop seizure detection algorithm for this vulnerable population. I want to spend a couple of minutes on the clinical IMED needs for this vulnerable patient population. Seizures and seizure mimics are highly prevalent in the neonatal intensive care unit or NICU. While research publications report that about 10% of NICU admits may have seizures, we believe that the true incidence could be even higher due to limited EEG access to identify seizures. The clinical consequences can impact the patient for their entire life. About 13% of patients with seizure in the NICU develop epilepsy within two years and up to 29% develop disabilities. A one-hour delay in treatment can lead to significant declines in cognitive and language abilities. On the other hand, unnecessary exposure to antiseizure medication has neurotoxic effects, which can also impact long-term cognitive function. Appropriate management of high-risk patients is imperative and current EEG capabilities are not sufficient to serve the needs of our most fragile patients. Recent updates to clinical guidelines signal a growing shift towards proactive seizure detection in neonates. In January, the American Clinical Neurophysiology Society issued new guidelines recommending seizure screening in at-risk patients in the absence of clinical cessation of seizure. This presents a new opportunity for our unique technology. We now successfully launched the first NICU pilot using our FDA-cleared hardware. The care team used our product in about 10 patients and validated the ease of use and signal quality in the neonate population. While we believe that the introduction of a seizure detection algorithm will maximize value to our customer, early use of the HECTAP alone is already demonstrating clinical and economic value. Moving on to delirium, we are pleased with the positive reception we received at the American Delirium Society Conference in June. We presented Cerebell's product vision and prototypes to the key opinion leaders. Their consistently positive feedback and overall excitement underscores the alignment between Cerebell's development strategy and the future direction of delirium research and clinical practice. The strong alignment is particularly meaningful given the clinical unmet need in the delirium space. This is a market where there is no commercially available diagnostic device, despite delirium impacting 20 to 50% of non-mechanically ventilated patients and 60 to 80% of mechanically ventilated patients in the ICU. Our algorithm would be significant to the market as it would be the first and only objective measurement of this very challenging condition. It would also potentially allow physicians to continuously monitor the patient and assess how the situation evolves and determine whether the patient is on the correct path for delirium management. We are very excited about our pipeline, which we believe will significantly expand our total addressable market by extending the benefits of the Cerebell system to more patients in need. We look forward to providing more updates once the regulatory clearances or other strategic milestones are achieved. Overall, our near-term focus remains on becoming the standard of care for seizure management in the acute care setting. We aim to expand Cerebell access to the millions of patients who are receiving delayed or suboptimal diagnosis due to the inherent limitations of the conventional EEG. This represents a two billion annual revenue opportunity in the US alone. Our longer-term mission is to make EEG a vital sign. With our continued commercial success and investment in R&D, we have high confidence in our ability to achieve this mission. Finally, before turning the call to Scott, I'd like to address our recently disclosed effort to defend our intellectual property against infringement. On July 7th, we announced that we filed a complaint with the United States International Trade Commission and a separate related complaint in the US District Court of Delaware against Natives Medical Incorporated and related subsidiaries. Our complaints allege patent infringement and unfair competition by NATOs. We assert that the recently launched and NATO's brainwash system infringes on six of our patents relating to important features of the EEG headband and electrical design. Together, the two complaints seek a judgment of infringement, a judgment for damages, and injunctions preventing further infringement and importation of infringing products from overseas suppliers. The ITC forum provides an expedited pathway to efficiently address NATO's alleged infringement. And the typical ITC case can be resolved as soon as two years or less. If we are successful at the ITC, NATOs will no longer be able to import the infringing products for sale in the US. With context and clarity, we have been building our extensive patent portfolio since the founding of Cerebell. And our actions are consistent with our corporate strategy to rigorously protect our intellectual property rights. We believe we have a strong case and remain committed to protecting our proprietary inventions for the benefits of patients, healthcare providers, shareholders, employees, and others who rely on us. The complaints are a proactive measure to safeguard our innovations against unauthorized use. We remain the clear category leader and expect to maintain our position through the merits of our patented technology and our commitment to further innovation. In conclusion, we remain focused on the proven strategies that has driven our success to date and that we believe will continue to enable Cerebell to become the standard of care. This includes investing in our commercial organization to drive adoption of the Cerebell system for seizure detection in both new and existing accounts. Continuing to drive awareness of seizures in the acute care setting by maintaining a leading presence in generating clinical and economic evidence. And finally, expanding our market through further product development and commercial launches. With that, I will now turn the call over to Scott Blumberg, RCFO, to provide a review of our second quarter results and outlook for the remainder of 2025.

Thank

you, Jane.

Good afternoon, everyone. As Jane mentioned, total revenue for the second quarter was $21.2 million, a 38% increase from $15.3 million in the same period of the prior year. The increase was primarily driven by the new commercial expansion, resulting in increased adoption of the Cerebell system across new and existing accounts. Product revenue for the second quarter of 2025 was $15.9 million, representing an increase of 38% from $11.6 million in the second quarter of 2024. Description revenue for the second quarter of 2025 was $5.3 million, representing an increase of 41% from $3.7 million in the second quarter of 2024. Gross margin for the second quarter of 2025 was 88% compared to 86% in the prior year period. Total operating expenses for the second quarter of 2025 were $33.6 million, an increase of 56% compared to $21.6 million in the second quarter of 2024. Non-cash stock-based compensation expense was $3.2 million in the second quarter of 2025. Increasing operating expenses was primarily attributable to investments in our commercial organization, increased headcounts to support the growth of the business, and expenses related to operating the public company. As a reminder, our investments to expand our sales force have a delayed impact on revenue contribution due to the time required to train reps, acquire customers, and launch new accounts. We expect these investments, which were made over the past year and are continuing in the Q3, to increase the rate of account acquisition beginning in 2026. Sales and marketing expense decreased $600,000 in Q2 compared to Q1. The sequential decline was driven by expenses related to our annual sales meeting included in Q1 and the timing of headcount and associated compensation expense. General and administrative expense in Q2 increased by $1.4 million relative to the prior quarter, largely as a result of expenses associated with preparation of our IPC and district court IP complaints filed in July. Stock-based competition expense increased in Q2 as a result of our move to public company equity competition practices. We expect stock-based compensation expense to increase with full year 2025 stock-based competition expense at or slightly below our guidance of $15 million. Net loss was $13.6 million for the second quarter of 2025 or a loss of 38 cents per share compared to a loss of $8.9 million or a loss of $1.61 per share in the second quarter of 2024. Average weighted share count of 36.3 million shares was used to determine loss of share for the second quarter of 2025. Our cash equivalents and marketable securities of the June 30th, 2025 were $177.4 million. Looking ahead, we remain committed to our goal of achieving cash flow breakeven with cash on hand and the strength of our balance sheet gives us a high degree of confidence that we can achieve this. Turning now to our outlook for the remainder of 2025. Given our momentum in the second quarter of 2025, we now expect full year 2025 revenue to range from $85 to $88 million up from our prior guidance of $83 to $87 million, which represents annual growth of 30 to 34% over 2024. On gross margins, we expect full year 2025 to be in the mid to high 80% range. We've accelerated acquisition of headbands from our supplier upon the temporary reduction in tariffs in China. It's estimated we currently have sufficient inventory to service our anticipated demand for the remainder of the year. Additionally, we have initiated our previously discussed strategies to de-risk our supply chain amidst the uncertainties of the current trade environment. Part of our near term mitigation plan, we have taken steps to establish our production line in Vietnam to create redundancy and benefits and potentially more favorable trade policies. We expect our manufacturing site in Vietnam to be operational by the end of Q3. The speed of this transition illustrates our ability to quickly adapt to a changing trade environment, maintain supply chain security, and continue to deliver industry-leading gross margins. We believe our supply chain strategies put us on track to deliver gross margins in the mid 80% range for the full year of 2026, assuming no changes to currently proposed

tariffs. With that, I'll turn the call back to Jane. Thank you, Scott, and thank you all for

your time today. In conclusion, I'm very pleased with our strong second quarter performance, which has positioned us well for continued success through 2025 and beyond. We have substantial growth runway ahead of us, as we currently serve only around 3% of the US patients who could benefit from our technology and are building further upon our industry-leading patent-protected platform. The future of Cerebell is brighter than ever, and we thank our employees, our customers, and the patients we serve for enabling us to continue our mission to help save lives while delivering substantial value to our stakeholders. Finally, we appreciate your support and continued interest in Cerebell, and 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? Thank you. We will now begin the question and answer session. If you have dialed in and would like to ask a question, please press star one on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star one again. If you are called upon to ask your question and are listening via speakerphone in your device, please pick up your handset to ensure that your phone is not on mute when asking your question. Again, press star one to join

the queue.

And

our first question

comes from the line of Travis Steed with Bank of America. Your line is open.

Hi, everybody. Congrats on a good quarter in the guide raise. Maybe just to start on the question, I'd love to kind of get kind of an update on some of the momentum in the business and what you're seeing on account ads and the awareness of Cerebell out there and utilization and kind of double digit utilization growth, again, kind of sustainability around that and some of the new reps that you've hired and territory managers that you've hired, sustainability of the ramp on those ads.

Hey,

Travis, I can take that.

Yeah, we're seeing good momentum on all fronts. As a reminder, most of the commercial investments we've made over the past year, especially in the territory manager side, given the sales cycle, we don't expect to drive tangible growth in the account base until next year. Of course, internally, we're tracking along on the underlying metrics around the stages of pipeline and the number of customers we touch and how those progress through the pre-PO stages and it's going quite well, so we continue to have confidence that that's going to bear fruit. As far as usage goes, our cams continue to make an impact. As we've talked about over the past number of calls, we do see lower seasonal usage in Q2 and Q3 relative to Q4 and Q1, but the outcome this quarter was well in line with what we expected.

Very great. And then I just wanted to follow up on the gross margin. It looks like you're kind of getting back to your old run rate in 2026, kind of where you were before all the tariff stuff. How much of that is the mitigation versus the rates being better? And could there even be a potential upside to that over time?

It's both. Our strategy of diversifying our supply chain in Vietnam, both is to mitigate the macroeconomic and trade risk with being relying on a single country, but beyond that, the current narrative of tariff rates coming out of Vietnam appears to be lower than what we were paying even during this break from China. And we'll continue to make decisions on our production jurisdiction based on what we learn along the way. But as you mentioned, we are continuing to make improvements in underlying cost structure, both in our China and Vietnam manufacturing sites. And a portion of that is included in our guide to be in the mid 80%

range next year. Okay, great. Thanks a lot.

Our next question comes from

the line of Robby Marcus with JP Morgan. Your line is open.

Oh, great. And congrats on a good quarter as well. Maybe for me, can you remind us of what seasonality is like with respect to EEG? And just speak to some of the trends you saw on utilization at your hospitals, think about any color on new or existing accounts.

Typically, we see a reduced seasonal usage in Q2 and Q3 relative to Q4 and Q1. That aligns pretty well with the macro level data that we get from various sources around what ICU census is. So we believe that that's a direct cause. We've seen it over this year and we've seen it in the past years as well. And so we've appropriately prepared for it. What we look at internally, and Jane can speak more to this, is some of the initiatives that our CAMHS are undertaking to drive usage. And those have been very effective.

Yeah. And to add to what Scott said, many of the usage initiative where driving is in many ways independent of the seasonality. As we mentioned before, we continue to focus on very specific patient population with strong guideline support and help hospitals to protocolize those workflows. And also in this rapid changing macro environment, we are also partnering more with administrators to help both the care team as well as administrators to see the health economic benefits using their own data. So all these initiatives we have started a few quarters back, we start to see very measurable and quantitative impacts.

And then maybe on expenses, you had pretty good expense control in the quarter, particularly on selling expense. Maybe speak to some of the undertakings of the company, how you're deploying the sales force and how you're thinking about expenses for the rest of the year.

We don't provide specific op-eds guidance, but our investment philosophy hasn't changed, which is we're deploying the capital raised in our oversubscribed IPO to drive future growth, both in the R&D engine and commercial expansion. As Jane mentioned in her prepared remarks, we are on the territory manager side approaching the end of our planned expansion of territories and plan to hold relatively consistent there, but we will look to invest in the CAM side of the business, which will grow relatively in line with the growth of the account base. We're also looking at other areas to invest opportunistically to drive future growth.

Great, thanks a lot.

Next question comes from the line of Brandon Vasquez with William Blair. Your line is open.

Hi, everyone, thanks for taking the question and congrats on a nice quarter. I wanted to ask first on utilization, as the account base keeps growing, I'm curious if you could talk a little bit about segmentations of utilization growth and how they grow over time. Is this simply a matter of you kind of look at tenure of accounts, do they kind of linearly grow in utilization or is there something else that you see in the data set that makes some accounts drive utilization more than others, just trying to get an understanding of what kind of underlying trends there look like when you look at the accounts segmented by utilization?

Yeah, we look at our utilization, say in three dimensions in growth. The first one is departmental penetration or expansion. In many of our accounts, we're still not in all the departments and all the departments would include all the ICUs, emergency departments, as well as the floor. So in many of these accounts, we'll be intentionally driving departmental expansion. The second dimension is physician training. So in many of the departments we are already in, we have not been able to always train 100% of the providers on the bedside, partially driven by the natural turnover and also is driven by it's very challenging to train the night shifts or the weekend shifts. So we have specific initiative internally to address that. The third dimension, as I mentioned earlier, is really focused on specific population and supporting the nursing and physician team to think about driving port equalization. So these are overall the three dimensions. I would say they apply to majority of our customers because most of our customers have ICU and ED, have the different physician provider groups as well as the different patient population.

Okay, that's great. And then Jane, maybe I think you guys are kind of still early days in this in kind of a limited launch in the pediatric side. Talk a little bit about what, even if it's just anecdotal at this point, any updates there, how things are going and how that may progress from kind of a limited launch into a little bit of a broader launch in the coming quarters of year. Thank you.

Yeah, since our FDA clearance in April, we started, we call it the pilot or limited market release of the pediatric. We are actually making progress on multiple fronts. As I mentioned in the last call, the two areas, one is in the children's hospital and we have not penetrated in majority of the children's hospital. The other is the pediatric population in the emergency department. So the initiatives we are making progress and driving are for example, doing QI quality inference projects with the key opinion leaders to show the prevalence of seizure in the pediatric, in the ED context because this population just never had EEG in the emergency department before. So we can see how many seizures could be potentially missed and also in parallel workout, what's the right workflow for this population in different departments. And meanwhile, all these exercise also help us to truly understand deeper of the patient needs here as well as the dynamics in this specific segments. And all this would enable us to maximize our go-to market plan as we launch the product formally down the road.

Next question comes from the line of Joshua Jennings

with TD Cowan, your line is open.

Hi, good afternoon. Thanks for taking the questions. I was hoping to start on the pipeline. Chance great to hear that the early buzz is being generated by the delirium indication and I was hoping to just review just the economic value proposition as you see it rolling out. And is it gonna be driven by decreased length of stay, decreased kind of workup costs in terms of pinning down delirium, but if in the future once approved, if a hospital adopts the cerebral technology and utilizes the point of care EEG to make a delirium diagnosis, how much cost savings could we see and maybe compare the economic value proposition to the cerebral EEG solution?

Yeah, thank you, Josh. We

see a lot of parallel in terms of health economic benefit between delirium and seizure. Since we're not launching delirium yet, so we probably won't be able to provide super specific health economic benefit as we do on seizure. However, at high level, one angle is what you already mentioned since most of all these patients are under DRG, most of these patients for inpatient under DRG, which means the revenue is relatively fixed. So reducing length of stay would be a major value driver. There are plenty of clinical evidence has shown that when patient have delirium, the ICU or the hospital length of stay is significantly higher. So we expect that when you have a more objective, continuous measurement that help physician to optimize the management of delirium, we could potentially see a thing or there as we did in seizure. And also similar to seizure, we received a breakthrough on delirium as well. And there could be association of NTAP and breakthrough, which we commonly see. And of course, there's always uncertainty there. So overall, we see a lot of parallel. And this is what we will be focusing on in generating more clinical evidence as well as health economics evidence when we launch new indications.

Excellent. And then I was hoping to just better understand the pricing strategy and what the experience was in the first half of this year and any help just thinking through headband pricing and clarity pricing for second half 25 and going into 2026. Any change from trend in 24? Thanks for the help and congrats on the nice two queue.

Thanks Josh. The headband pricing has been relatively consistent year over year. We've continued to opportunistically look at price increases where appropriate, but we also wanna be judicious with those and appreciate that a lot of hospitals are on our economic stream right now. We have been able to effectively increase the rate of clarity, the clarity ASP over time. And a lot of that's treatable

to driving more recorders through the subscriptions.

our next question comes from

the line of Bill Quavani with Canocorgenetic. Your line is open.

Okay, great, thanks. Thanks for taking my question. Just on the, just start off with cost for Scott, just on the ongoing legal. You mentioned that your GNA was a little elevated in Q2 because you're prepping for all of this. How should we think about the incremental costs over the next couple of years to legal? And then just on the delirium, you know, I think, how do we think about as you come to market with this product, how do we just think about, is there a certain, I guess with Epilepsy, as Epilepsy is, there's a certain pathway, a guideline on how to treat those patients already in place. Is there something similar with delirium? That there's a specific pathway of how to treat them or it just changes the, what they're, how they're going to treat them if they know they have delirium? Thanks for taking my question.

On the cost of legal, you know, we do expect an ongoing cost associated with the action, of course, that'll depend on the response and how long that lasts. But what I'll say to guide you is the amount of increase that we saw relative to normal in Q2 should about reflect what we're gonna see in the coming quarters of 25 and 26.

And on the delirium treatment, it is true that it's different from seizure management in that seizure management focused on very clear first line, second line treatment and that's mostly medication. Delirium doesn't have a single medication and that's proven to be effective or recommended by the guidelines, especially in the hypo delirium patient population. However, that being said, there's clear treatment pathways that the societies has developed a clear guideline and that involves in looking into potential medication, especially sedatives that can cause delirium therefore to eliminate certain medication from the patient or finding other root cause, potentially infection and other underlying unbalanced iron level treatment. So those can be different root cause for delirium. It's critical to identify those root cause and that can help delirium management. Another factor of delirium is that these patients often stay ICU for days or even weeks. And it's a disease state that can wax and wane and evolve over time. So often when physicians put patients in one treatment path, it's very hard for physicians to know, it could be hard for physicians to know whether or not they're on the right path. And this is where we received some of the feedback from the key opinion leaders at ABS that objective and the continuous monitoring device can help the physician not only to more accurately and potentially detect delirium early, but to know that whether or not they're on the right path in managing these patients.

Great, thanks for taking my question.

Thank

you,

Bill. Next question comes from the line of Jeffrey Cohen with Leidenberg-Thalmann. Your line is open.

Well, hi Jane and Scott. Thanks for taking our questions. I guess, firstly, could you delve into the neonate indication a little bit? Could you talk a little bit more about the pilot and number of patients and number of centers that you would anticipate to run through this and as far as timing when we may see some initial data?

Yeah, we don't disclose specific patient population or specific sites, but the pilot is still, I would say, relatively small. We're not talking about hundreds of sites. We're talking about probably a single, low double digit. And the reason is that for the pilot, we're really trying to achieve one, to further validate the ease of use and signal quality of our FDA cleared hardware, which is both the recorder as well as the head cap. And B, probably more importantly, it's again, understand specific patient needs here in this very unique patient population and also the specific dynamics workflow in the NICU. So all this would inform us when we are developing our -to-market plan. As we mentioned in the last earnings call, we will be sharing FDA clearance or approval when they come or other strategic regulatory milestones. So at the moment, we do not have those milestones to share, but what we can share is everything is on track related to our pipeline according to our internal milestone. And some of them are even ahead of schedule.

Got it, that's helpful. And then secondly, could you talk a little bit about the shift on the manufacturing to Vietnam? You did mention this could occur by the end of Q3. Is that gonna be a sole shift in its entirety or do you expect to have two facilities running? And then just clarify for us, will that be separate the both clarity as well as the headbands? Thank you.

We expect to maintain our current suppliers in China as well. The Vietnam facility is really to de-risk the single country supplier as well as to be able to change our manufacturing jurisdiction in order to take advantage of the differing trade policies we see. So I would consider it an added line. As it relates to manufacturing, we do a lot of the manufacturing related to the headbands internationally in China, Vietnam with final assembly inspection here in the US and the recorders have always been and will continue to be manufactured here in the US.

Okay, perfect. Thanks for taking our questions. Congrats on the quarter.

Next question comes from the line of Marie Thibault

with BTIG. Your line is open. Hi, good evening. Thanks for taking the questions and congrats on the nice quarter. Wanted to ask here, I think I heard in the prepared remarks that there would be opportunistic investments for the territory count. What are some of the drivers that would determine whether you make those investments?

Part

of our core strategy and how we operate is we always run pilots. So usually before we invest extensively in any initiative or function, we would have a rather proven pilot. So we have multiple commercial pilots ongoing and as we see strong signals and that's when we will pull the trigger to take those opportunities.

Okay, so strong signals from within a region or specific territory. Okay, very helpful, Jane. And then what are you hearing anecdotally so far? What are your sales folks seeing in the field from the competition given their recent launch?

Yeah, we created the Point of Care EEG Calibri. So there has been competition pretty much since day one we launched the product. With our success growing, we see more emerging players and more activities. However, we see the competition activity not really impacting our commercial performance as you could see from our Q2 performance and that we have high confidence to raise our 2025 guidance. The reason is that we fundamentally believe that our product is significantly superior than what's available from the competition. It's highly validated by hundreds of thousands of patients and our clinical evidence. The fact that we have a FedRAMP, which is one of the highest cybersecurity certification that any company can get, it really differentiates us as our customers pay more attention to cybersecurity now. So overall, we remain highly confident that we will remain the dominant category leader. Wonderful, very encouraging.

Thanks for taking the questions.

Thank you, Mary. That concludes the question and answer session. I would like to turn the call back over to Jane Chow for closing remarks.

Well, thank you everyone for your time. We are very pleased with our strong Q2 performance and we look forward to sharing more progress down the road. Thank you.

Ladies and gentlemen, that concludes today's call. Thank you all for joining and you may now disconnect.