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CeriBell, Inc.
2/25/2025
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 redraw your question, press star one again. I would now like to turn the conference over to Brian Johnston, Investor Relations. Please go ahead, sir.
afternoon and thank you all for participating in today's call joining me from sarah bell are jane chow co-founder and chief executive officer and scott holmberg chief financial officer earlier today sarah bell issued a press release announcing financial results for the quarter and year ended december 31st 2024. 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 statements 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 10Q filed with the SEC on November 12, 2024. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, February 25, 2025. Therabell 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. And with that, I'll turn the call over to Jane.
Thanks, Brian. Good afternoon, and thank you all for joining us today on our fourth quarter and full year 2024 earnings call. Today, I share key highlights of our fourth quarter results, and our outlook and strategic priorities for 2025. Scott will then provide a more detailed analysis of our financial performance and discuss our full year 2025 guidance. 2024 was a transformational year for Sarah Bell. I am incredibly proud of our team's many accomplishments. We made significant strides in driving commercial growth and laying the foundation for our R&D pipeline while beginning our journey as a public company. Most importantly, we made a life-changing impact on tens of thousands of patients, their caregivers, and their families. To that end, I'm pleased to report that our technology has been now used on over 200,000 patients since we first launched. For perspective, this likely translates to thousands of saved lives, tens of thousands of patients who avoided unnecessary medication and intubation, and potentially hundreds of thousands of unnecessary ICU days avoided. Before reviewing our performance, and expectations for 2025 in greater detail, I would like to take a moment to share a recent patient story that I feel perfectly illustrates the real-world impact of our mission. In this case, the 64-year-old woman arrived in emergency department of a local hospital. She was unable to follow commands and had difficulty speaking. Her care team suspected a stroke and immediately ordered a CT, which came back negative. The stroke-mimic patient was awake but continued to suffer from a variety of symptoms, including a fascia, facial droop, and mouth twitching that suggested ongoing neurological abnormalities. Her care team then applied a cerebral system to evaluate for seizure activity which quickly showed a 100% seizure burden, indicating non-compulsive status epilepticus. Empowered by this information, the care team was able to promptly and confidently administer anti-seizure medication, which resolved the seizure in under an hour. The patient was then transferred to the ICU where Cerebell was used for continuous EEG monitoring, during which time the patient remained seizure-free. Within 24 hours, the patient was stabilized and discharged from the hospital. Without Cerebell, this outcome likely would not have been possible. The patient may have remained in seizure much longer, potentially resulting in a poor clinical outcome and much longer length of stay in ICU. Further, this case validates findings from a recent study supporting the use of Cerebell EEG for identification of seizures in patients with stroke symptoms. In this study, a third of stroke mimic patients were found having seizure or high epileptiform abnormality, and Cerebell was found to be a critical tool in detecting nonconvulsive seizures in stroke evaluations. This experience is just one of many thousands like it. The impact we have on patient care every day is a core driver of the passion we have for our mission to optimize the standard of care. With that, let me shift to our first quarter and four-year results. I'm pleased to report that the revenue for the fourth quarter of 2024 was $18.5 million, reflecting 41% growth over the same period last year. For the full year, the revenue totaled $65.4 million, representing 45% growth over 2023. In both the fourth quarter and full year 2024, we maintained a strong margin profile with a growth margin of 88% and 87% respectively. Our strong first quarter and full year performance was driven by our team's continued success in acquiring and efficiently launching new accounts while also driving utilization across our established account base. Turning to our commercial performance, our active account sat at 529 accounts as of December 31st, an increase of 25 during the first quarter. For perspective, we estimated that there are 6,000 acute care facilities in the U.S. that could benefit from our offering. We intend to continue targeting the approximately 5,500 remaining prospective accounts through the efforts of our growing and increasingly tenured team of territory managers while driving penetration within existing accounts through our team of clinical account managers. Meanwhile, we continue to leverage both sales functions to facilitate high-quality account launch processes. Based on our experience, we believe that this approach through launches enable durable long-term utilization. We saw this strategy in action during a recent account launch where our territory and clinical account managers worked closely on the ground to educate clinicians on the use case and the benefits of the Cerebral System. Moments after our team left, The cerebral system alerted 80% seizure burden detected for the very first patient who was monitored during the launch period. The neurologist was immediately consulted, and the patient was quickly treated. Clarity then continuously monitored the patient to assess the treatment effectiveness. This was a breakthrough for the entire care team. and the hospital's administrators. A-ha moments like this reinforce the value of the Cerebell system and highlight the major care gap that existed before the adoption of our technology, often resulting in durable, sustained clinical usage patterns. At a high level, our commercial strategy for 2025 is to maintain our key areas of focus and build upon our success in 2024. We will also continue to invest in and expand our commercial organization led by Sean Manny, who we are promoting to Chief Revenue Officer. We are currently on track to our goal of expanding our account acquisition team to 55 territory managers by mid-2025. We expect this expansion will begin impacting our rate of account acquisition growth in 2026. Meanwhile, we intend to continue building on our efforts to expand awareness around the clear clinical and economic benefits of rapid EEG monitoring for seizure detection in acute care setting. We will work to expand awareness around the unique features and capabilities of Cerebel platform solution to further cement our position as the category leader. As we look forward, we also intend to continue investing in optimizing algorithm performance and user experience of existing products. while expanding the indication beyond seizure. We envision our pipeline across three horizons. Currently, we are focused on becoming the standard of care for seizure management in acute care setting. In the near term, we expect to have clarity indication expanded to include pediatric patients following our submission of a 510K application with FDA in late 2024. We are also working this year to finalize the development and testing of our neonate clarity algorithm ahead of the submission of a separate 510 application in 2026. On the second horizon, our medium-term goal is to make EEG a new vital sign. Though EEG has historically been limited to the identification of seizures in clinical practice, EEG have been scientifically demonstrated to aid in the detections of a wide variety of other neurological conditions. We intend to leverage our scalable proprietary platform and AI capabilities to develop algorithms to address unmet needs across many of these critical conditions, which are common in acute care setting. Importantly, we believe we will be able to target these novel patient populations within our existing call points, largely by leveraging our existing Salesforce. We expect that the first such indication will be for detection and monitoring of delirium, for which we have already received breakthrough device designation from the FDA. We are now actively preparing to submit the application to FDA later this year. 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% mechanically ventilated patients in the ICU. The occurrence of delirium during a patient's ICU stay can lead to severe long-term morbidity and is correlated with significantly worse outcome. Following anticipated FDA approval, we believe our novel algorithm will present a paradigm shift in how delirium is managed and ultimately improve patient care. Meanwhile, we have recently accelerated our investment in the development of a stroke detection algorithm. We have collected data on over 200 patients and counting. This data will help us to further refine our algorithm and inform our regulatory strategy. As part of our longer-range third horizon, we aim to develop solutions for use beyond the acute care setting. Scientific publications have shown that EEG may be a biomarker for multiple neurological and psychiatric conditions, such as depression, OCD, ADHD, and dementia. Our platform technology, which makes EEG simple enough to acquire outside the acute care setting, along with our expertise in machine learning, uniquely positions us to pursue potential products that target this very large patient population. We are very excited about our extensive pipeline and will continue strategically invest across these exciting initiatives to drive future growth. Meanwhile, we remain laser focused on the substantial growth opportunity we have within our current $2 billion market in the U.S. for the detection and the management of seizure in acute care setting. Overall, we are very excited by our progress to date and view 2025 as a catalyst heavy year for Cerebel. To summarize, in the coming quarters, we plan to invest in our commercial organization to drive adoption of the Cerebel system for seizure detection in both new and existing accounts. Continue to drive awareness of seizures in the acute care setting by maintaining a leading presence in generating clinical and economic evidence. And finally, make further strides in expanding our market through our investments in R&D. With that, I will now turn the call over to Scott Blumberg, our CFO, to provide a review of our fourth quarter results and 2025 guidance.
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