CeriBell, Inc. (CBLL) Earnings Call Transcript

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 Cerebral Q2 2026 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 time. If you would like to ask a question during this time, simply press star followed by the number 1 on your telephone keypad. If you would like to withdraw your question, press the star 1. I would now like to turn the call over to Brian Johnston of Gilmartin Group. You may begin.

Good afternoon, and thank you all for participating in today's call. Joining me from Cerebell are Jane Chow, co-founder and chief executive officer, and Scott Blumberg, chief financial officer. Earlier today, Cerebell issued a press release announcing financial results for the quarter ended June 30th, 2026. A copy of the press release is available on the investor relations section of the company 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, 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 on your 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 annual report on Form 10-K filed with the SEC on February 24th, 2026, and quarterly report on Form 10-Q for the quarter ended June 30th, 2026. Thank you. conference call contains time-sensitive information and is accurate only as of the live broadcast today, August 10th, 2026. Therabold disclaims any intention or obligation as HIPAA is required by law to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. And with that, I'll turn the call over to Jane.

Good afternoon and thank you for joining us for our second quarter 2026 earnings call. Q2 marked another strong quarter for Ferriville, as we delivered revenue of $28.1 million, growing 33% year-over-year. This is an acceleration from the 29% year-over-year growth we reported in Q1, which reflects a particularly strong performance in same-store growth driven by our clinical account management team. We also increased our account base by 32 accounts to a total of 712 active accounts. While the increase is similar to what we delivered in recent quarters, Q2 growth relied less on VA accounts than previous quarters. Our sustained success in growing our account base is the result of the continued maturation and performance of our account acquisition team. While revenue and commercial acceleration get popularly, I do want to take a moment to focus on our growth margin. delivered record growth margin of 92% in Q2. This number was positively impacted by a refund on previously paid tariffs. Even when excluding this refund, we delivered a gross margin of 89%. This does not happen by accident. It is a direct result of our proactive efforts in supply chain optimization and manufacturing diversification. And growth margin is more than just a number. It generates the outsized growth profit we're reinvesting to fund our growth initiatives and R&D with the eye towards executing our mission. With 33 consecutive quarters of sequential revenue growth, we believe we have built a repeatable growth engine by pointing that engine squarely at our defining objective, establishing Cerebell as the standard of care for seizure detection in acute care setting. At the center of our growth strategy is our commercial infrastructure, with the dual purpose to acquire new customers and drive deeper adoption within our install base. Our account acquisition team continues to mature and is contributing in line with expectations. Their efforts are being supplemented by our newly added strategic account management team through top-down engagement of regional health systems. We have built a robust pipeline of prospects that gives us confidence in our ability to maintain an accelerated rate of new account additions in 2026 compared to 2025. While we continue to expand our account base, our clinical account management team is providing revenue through headband utilization expansion. Our strong performance this quarter reflects execution of our established utilization playbook, provider engagement, department expansion, and patient population protocolization. A robust and expanding body of clinical evidence validates our platform. Our aim is to make the case for Cerebel's clinical necessity by investing in high-quality evidence, demonstrating the clinical and economic value our system delivers. Adding to our established base of over 150 publications and abstracts, in Q2, a high-impact study was published in Critical Care Medicine, one of the leading journals in intensive care research. Studies found that when our clarity algorithm reported a peak facial burden of 90% or greater, patients were 3.6 times more likely to experience severe disability or death at discharge. Further, each additional hour of a clergy detected seizure activity was associated with nearly twofold increase in that risk. The premise that longer seizure duration correlates with worse outcome is not new. What is new is that a device output can quantitatively report seizure burden at the bedside in real time. and that this burden reliably correlates with patients' outcome. These findings sharpen the clinical imperative for using the Cerebell solution, particularly clarity to reduce seizure burden for patients. As the body of evidence compounds, we're increasingly confident that Cerebral's path to becoming the standard of care is not a question of if, but when. As we continue to deliver within our core season market, we remain encouraged by the traction in our emerging market opportunities. we launched our neonate and pediatric products and the commercial pilot of our delirium algorithm. We remain encouraged by the early commercial traction of our neonate and pediatric seizure line extensions. customer interest remains high. The clinical conviction is translating into early commercial success as we secured purchase orders from both new and existing customers in Q2. a robust and growing pipeline. We are well positioned to translate our commercial efforts into revenue contribution as we move into 2027. We are also excited about the momentum of our first of its kind, Delirium Monitoring Solution, which received 510K clearance in December. Delirium represents an estimated $1 billion U.S. market for Cerebell and a strong addition to our platform. Despite being the most common neurological complication in the ICU, before Cerebell, there had been no commercially available tool to continuously monitor delirium. We launched our commercial pilot in April and are now live in multiple sites. The early feedback has been positive with users praising improvements in clinical decision-making. For example, based on the survey, 40% of the patients were difficult to assess under CAM-ICU, the current standard of care, but could still be monitored with the Cerebral Solution. Beyond the clinical signal, we are also seeing a utilization effect. Existing Cerebral customers that have joined the delirium pilot are increasing advanced utilization. We believe this is a reflection of both the clinical value of the delirium detection algorithm and the incidence overlap between seizure and delirium, and just scoring the synergistic value of our platform. We are also pleased to share that we just received a favorable final rule from CMS, establishing a new technology add-on payment or NTEP for our Delirium Monitoring Solution. The NTAP, which becomes effective October 1, 2026, provides up to $2,171 in incremental reimbursement per qualified patient. This is a meaningful milestone. It will support adoption by adding favorable economics to the strong clinical interest we're already seeing in the field. Our launch strategy is coming into focus. And we now have the confidence that we will launch Gilerion commercially this year. With the commercial and clinical updates covered, I'd like to turn to our vision for the future. We believe we are well on our way to establishing the Cerebell system as a standard of care for seizure management. At the same time, our longer-term vision to establish EEG as a new vital sign is no longer theoretical. We have made material progress and believe we can begin translating this vision to reality in 2027. Enterpene-ness is a two-pronged product strategy. We invested in algorithm and hardware enhancement to reach more patient populations while improving patient care and meeting physician needs. Our first prong is centered around developing novel algorithms to further improve clinical decision-making. Valerian and LVO are excellent examples of clinical expansion to new patient populations under this strategy. Through these advancements, rare delivery continues objective brain monitoring to a set of underserved patient populations. We also apply algorithm development to improve care for patients we already serve. We are pleased to announce today the receipt of FDA 510 clearances for two new algorithms, targeting our core seizure market. We believe each meaningfully adds to our platform clinical utility, strengthening the case for TheraVal as the standard of care. First, represents a significant enhancement to clarity's ability to identify and reduce EEG artifact signals. Artifact recognition has long been the leading challenge to EEG interpretation in the acute care environment. not uncommon for even neurologists to mistake electrical signal from various medical equipment as seizure activity. EEG is so sensitive that even the electrical signal from an IV drip's movement can create artifacts. Our new algorithm trained on a large artifact database created by Cerebell can differentiate between brain activity and artifact, adding a layer of AI-driven sophistication. The new algorithm significantly simplifies EEG interpretation for neurologists and improves the point-of-care experience. We anticipate rolling this out in the third quarter. The second clearance is for epileptiform abnormality detection. This algorithm targets abnormal brain activity in a gray zone between clear seizure and normal signals. This activity is clinically important, but has historically been difficult to consistently measure. our knowledge, Cerebel is the first software to be FDA cleared for the detection of both seizure and epileptic form abnormality. This is the capability that neurologists have specifically asked for, and we are proud to be the first one to deliver it. We expect to activate this algorithm by the end of the year. These new algorithms serve to strengthen the clinical benefits offered by our system. We believe that by widening the gap between the value offered by Cerebral System compared to conventional EEG, we create a clinical imperative to adopt our leading-edge technology. The second prong of our product strategy centers on enhancing and expanding our hardware platform. Over recent months, we have received FDA 510 clearances for several products that together form the foundation of our new hardware platform. This includes clearances for a recorder with video and ECG capability, compatibility to integrate with other vital sign measurements, and the ability to monitor continuously while plotting. We have also received clearances for two headband designs that provide optionality for formal touch and multiple day continuous monitoring when needed. The features offered by our new platform serve to support our effort to make EEG a new vital sign. For example, delirium patients often require days in the ICU before resolution. and the new system can be even more seamless in supporting this new use case. And when we add LVO in the future, a bigger screen will be needed to monitor multiple disease states. Within our core market, we believe our current product is optimized for the majority of patients in acute care setting. It is quick, simple, and reliable in a care setting where these are the most important needs. However, with our hardware line extensions, clinicians no longer have to worry about the cost of the product. longer have to choose between the speed of point of care EEG and the comprehensiveness of conventional EEG for patients who need both. Cerebel can offer both with one device. We are continuing to test our products, refine the design, and scale our manufacturing with the target launch of our new hardware platform in 2027. We will share more details as we get closer to the product launch. As I step back, struck by how much is converging at once. Our core business continues to perform, delivers 33% year-over-year growth and an acceleration compared to last quarter. We are the first and only point-of-care seizure platform indicated for use with patients of all ages. At the same time, the work we have been building towards for years is coming to a head. New algorithms, new hardware appearances, a delirium pilot tracking towards commercial launch and a new ANTEP. These advancements stand to meaningfully strengthen our value proposition while reinforcing our market leadership position with significant innovation-based barriers to entry. We see 2027 as a pivotal year with Neonate gaining more scale, Delirium commercially launched, our expanded hardware platform on the market, and an increasingly mature Salesforce delivering even greater impact. I'm more convinced than ever. that we are building the right platform at the right moment. Our goal of creating a single brain monitoring solution for the acute care setting is within reach. With that, I will now turn the call over to Scott Blomberg, our CFO, to provide a review of the second quarter results and 2026 guidance.

Thank you, Jane, and good afternoon, everyone. As Jane highlighted, total revenue for the second quarter of 2026 was $28.1 million, which represents a 33% increase from $21.2 million in the second quarter of 2025 and a 6% sequential increase quarter over quarter. The increase was primarily driven by the success of our same-serve growth strategy, in addition to increased adoption of the CeraVel system across new and existing accounts. PRODUCT REVENUE FOR THE SECOND QUARTER OF 2026 WAS $21.2 MILLION, REPRESENTING AN INCREASE OF 33% FROM $15.9 MILLION IN THE SECOND QUARTER OF 2025. Subscription revenue for the second quarter of 2026 was $6.9 million, representing an increase of 30% from $5.3 million in the second quarter of 2025. We ended Q2 with an active account base of 712 hospitals, representing an increase of 32 accounts in the quarter. We have been pleased to see our investments in driving same-store growth continue to deliver. While we saw signs of typical seasonality in Q2, when warmer months tend to result in reduced ICU census, our same-star growth performance exceeded expectations, including an acceleration in year-over-year growth from recent quarters. We continue to believe that we have a significant untapped growth opportunity within our install base in which our top accounts continue to use our product at roughly three times the rate of average accounts of similar size. Gross margin for Q2, 2026 was 92% compared to 88% in the prior year period. This includes the impact of $1.6 million in tariff refunds received in the quarter, of which $1 million was recognized in cost of goods sold and $0.6 million was capitalized to inventory. Excluding this adjustment, gross margin was 89%. Our strong margin for quality is a direct reflection of cost reduction efforts and the expansion of manufacturing capabilities in Vietnam. We feel confident in our ability to maintain gross margins in the high 80% range throughout 2026 based on current fair policies, and believe we have built flexibility in our manufacturing capabilities to manage any future policy shifts. Total operating expenses for the second quarter of 2026 were $45.9 million, an increase of 37% compared to $33.6 million in the second quarter of 2025. Non-CAS stock-based compensation expense was $6.0 million in the second quarter of 2026 and $3.2 million in the prior year period. Sales and marketing expense in the second quarter grew as a result of headcount expansion, including the newly established strategic account management function and expansion of our CAN infrastructure in advance of delirium launch. G&A expense remains elevated in the second quarter of 2026 as a result of expenses related to our ongoing IHIN, which total $3.9 million. Looking ahead to the third and fourth quarters of 2026, we anticipate a reduction in lawsuit-related activities and associated expense. Research and development expense in the second quarter reflects investments we've made into our platform, including our next generation hardware, algorithm development, and clinical studies. NET LOSS WAS $19.3 MILLION FOR THE SECOND QUARTER OF 2026, OR A LOSS OF 51 CENTS PER SHARE COMPARED TO A LOSS OF $13.6 MILLION OR A LOSS OF 38 CENTS PER SHARE IN THE SECOND QUARTER OF 2025. An average weighted share count of 38.0 million shares was used to determine loss per share Last quarter, we instituted the disclosure of adjusted EBITDA to represent the ongoing operating performance of our business. Adjusted EBITDA reflects our net loss before interest, taxes, depreciation, and amortization expense, and also excludes non-cash stock-based compensation expenses, as well as legal expenses associated with our ongoing IT litigation. Adjusted USL loss for the second quarter of 2026 was $9.8 million as compared to a $10.0 million loss in the second quarter of 2025. This reflects our continued strategy of thoughtfully deploying gross profits from our expanding revenue base back into the business to pursue long-term growth opportunities. Our cash, cash equivalents, and marketable securities as of June 30th, 2026 were $129.3 million. We remain committed to our objective of achieving cash flow break-even with cash on hand, and the strength of our balance sheet and strong gross margin profile give us a high degree of confidence in our ability to do so. Finally, following close of the quarter, we successfully refinance our existing credit facility, securing access to up to $60 million in committed capital with an additional $25 million uncommitted. The structure includes a non-formular revolver plus term loan that remains available to draw through year-end 2028. We expect that this structure will reduce our interest expense starting in Q4 and extend our repayment timeline by roughly three years into 2031. We do not have plans to draw the committed but undrawn term loan in the near term, but we believe that its availability will provide us with greater strategic flexibility. Turning now to our outlook for 2026. We expect full year 2026 total revenue to range from $114 to $117 million, up from our prior guidance of $112 to $116 million. This references annual growth of 28 to 31% over 2025. This change to guidance reflects the momentum we are seeing in our core business, with success driven both by new account additions and usage within our established account base. This range does not include material contributions from our neonate, pediatric, or delirium product, which we expect will begin to translate into revenue more meaningfully in 2027.

With that, I will turn the call back to Jane. Thank you, Scott, and thank you all for your time today. Q2 reinforced the confidence we have in our trajectory. Our core business is growing and accelerating. Our commercial execution across new accounts, utilization, and neonate is on track. and the product and clinical evidence investments we have been making are beginning to compound in ways that will matter over the next year and beyond. We have less than 4% penetration in our core seizure market. This tells you how much runway is still ahead of us. And we are advancing into new greenfield markets with urgency and purpose. Our mission to establish EEG as a new vital sign remains our North Star. And the progress we made in Q2 gives us every reason to push harder.

Now I will turn the call over to the operator for 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. 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. We do request for today's session that you please limit to one question and re-queue for any follow-up question. Thank you. Our first question comes from the line of Travis Teed with Bank of America. Your line is open.

Hey, congrats on the progress. I wanted to spend a little more time on all the FDA approvals that you guys have gotten and put together. And I don't know if there's anything else you want to add to that, but I think the real question is, like, what can all these approvals and new indications and everything do for kind of the revenue growth rate and kind of the incremental revenue dollars you can add to this business that'd be kind of helpful to context but anything else you want to say on all the approvals would be helpful just to put in context for everybody.

Yes. Thank you, Travis. So, I will put our recent FDA clearance into two groups aligned with our two-prong strategy. The first groups are the algorithm clearances that include artifact rejection as well as epileptiform abnormality. As we launch both of these algorithms, algorithm later this year, we do not plan to charge more, but we see this tool will be very beneficial, especially for the neurologists. And directly or indirectly, this would further increase the stickiness and potentially increase the utilization as a count. We have always seen our top accounts always have very strong neurologist support. So we could see at this as a leverage to drive usage and potentially increase the deal velocity as well. In terms of our new hardware platform, we are not launching this platform yet, and similar to the previous strategies we have deployed, we are planning on a limited market release for the new hardware platform and potentially launch the platform in 2027. This new hardware platform really has been aiming at making EEG a new vital sign in junction to delirium and the future LVO we're working on. So we see this as giving us access to additional patients or even additional market segments. So we do see this can be a revenue driver in 2027 directly. As we get closer to the launch time, we will share even more details.

Our next question comes from the line of Robbie Marcus with JP Morgan.

open great congrats on the quarter and thanks for the question Scott, I wanted to ask on Op-Eps. Companies your size typically need to make a strong beeline towards leverage. And we've seen OpEx grow faster than sales the past several quarters. So maybe just speak to the investments and the spending that you're doing now. What's driving that? And when can we start to see leverage on OpEx? Thanks a lot.

Sure thing, Robbie. First of all, the two things I'd like to point out in the Q2 OpEx that were a little bit out of the normal is stock-based compensation sequentially increasing by about $2.3 million. an annual equity cycle that happens in Q2. So you'll tend to see that step function in Q2 and then carry forward until the next cycle. The other, of course, is the IP litigation, which remained elevated, lower than Q1, but higher than we'd expect going forward. As it relates to our investment philosophy, we've maintained adjusted EBITDA loss roughly at around 10 million, give or take, for the past many quarters in a row. Our strategy has been to continue to grow the top line, generate outsized gross profits with our high gross margin and then reinvest that back into the business. And that investment comes in the form of sales infrastructure in this quarter, both building the strategic account management function out as well as expanding our CAM infrastructure a bit ahead of our DeLorean launch, as well as R&D. And as we make those investments, we're very mindful of our objective to achieve cash flow, break even with cash on hand, having guided specifically as to when we come, but we keep a very close eye on it to ensure that we control our own destiny and make sure that we're self-sufficient as far as our cash position goes.

Next question comes from the line of Brandon Vasquez with William Beer.

Your line is open. Hey, everyone. Thanks for taking the question, and congrats on a nice quarter. Jane, I think you had mentioned that, you know, like there was kind of an inflection here, or a driving factor of growth in the quarter was from new account ads. There's clearly a bunch of tailwinds going on in the business with new indications and things like that. So I was hoping you could just spend a minute on unpacking, you know, are you guys seeing kind of like an inflection in interest from end users. I think you even said that neonate and pediatrics was driving new account openings that you weren't even in before. So just kind of give us a little bit of an update on interest in driving new accounts and expectations on how durable that can be going forward. Thank you.

Thank you, Brendan. Yes, definitely echo your statement. We do see a lot of tailwinds. On the account acquisition front, we saw the new purchase order related to Neonate, both in existing accounts as well as new accounts. And I would say in Q2, it's still relatively early phase. As you know, it does start. takes the sales cycle and we just launched the Neonate recently, we do expect the impact from Neonate is going to be even bigger second half of the year and especially in 2027. And as I mentioned in my previous call last quarter that we started the strategic account management team. So we also continue seeing the pipeline and the momentum from this team in closing accounts as the regional hospital system level. And we remain very optimistic for the impact to come later this year and in 2027. Another dimension of revenue drive, of course, is from the utilization or the same store growth. As Scott mentioned, Q2 usually is our low seasonality quarter, but the same store growth this quarter exceeded the expectation. And the majority of that is the continuous execution of the known plate scope we have. In addition to that, we also see coming tailwind as we later launch Delirium as the limited market release did show that these existing Cerebral Camps, when they start to use Delirium, it meaningfully increased the utilization as well. So we are very excited about the.

different tailwinds we're having. Next question comes from the line of Joshua Jennings with TD Cowen. Your line is open.

Good afternoon. Thanks, Jan, Scott. Congratulations on another strong quarter. I wanted to, you know, you've laid out some additional layers of growth that will be kicking in in 2027. Right now the street's projecting a 7% similar kind of revenue growth rate prior to today as the lower end of 2026 guidance that you just revised up. I don't think you're going to provide explicit guidance for 2027, but with pediatric neonate kicking in next year, delirium, you know, the, uh, new hardware, Cerebel headband platform, how should we be thinking about trajectory of growth. It seems like there could be an acceleration even in 27 versus 26.

Yes, Josh, you know, we're not yet going to comment on 2027 guide, but as you pointed out, there's a lot of tailwinds that are all coalescing around the same time. We feel really good about what we know. We feel good about what we learned on the new and early launch, the DeLorean pilot. There are still things we need to learn. learn how the Delirium launch plan for later this year goes, as well as the limited market release on the new product platform. But we've got about six or seven months here before we're guiding for 27, and we're learning. I'm very happy to share our learnings with you when we issue our guide.

Our next question comes from the line of Bill Povanek with Canaccord Genuity. Your line is open.

Hi, it's Zachary on for Bill. Thank you for taking the question and congrats on the quarter. Can you talk more about the magnitude of the gross margin impact from the Vietnam manufacturing shift? I thought that was going to be more impactful later in the year. It sounds like you're starting to get some benefit now. Can you try to quantify that, please?.

Thank you. Sure. I view the 89%, which effectively is if there had not been any sort of refund as effectively the steady state for where we are. I mean, as we've mentioned, we plan to be in the – expect to be in the high 80% range for the remainder of the year. That 89%, which would have been more than 80% for the remainder of the year, that's included the burden of tariffs is essentially back to where we were, even a little better, before all the tariff noise. And that's a direct reflection of both the manufacturing moves Vietnam, but also some general cost reduction initiatives that we put into place over the course of the last year and a half to.