speaker
Lateef
Conference Call Operator

good afternoon and welcome to the castra medical technologies third quarter fiscal 2025 earnings conference call this conference call is being recorded for replay purposes we will be facilitating a question and answer session following prepared remarks from management at this time all participants are in a listen only mode i would now like to turn the call over to neil baladkar vice president of investor relations. Please go ahead.

speaker
Neil Baladkar
Vice President of Investor Relations

Thanks, Lateef. Thank you all for joining Kestra's third quarter fiscal 2025 earnings call. With me today are Brian Webster, President and Chief Executive Officer, and Vasim Meboob, Chief Financial Officer. This call includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements made on this call that do not relate to matters of historical fact should be considered forward-looking statements. These statements are based on Kestra's current expectations, forecasts, and assumptions, which are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Actual outcomes and results could differ materially from any results, performance, or achievements expressed or implied by the forward-looking statements due to various factors. Please review Kestra's most recent filings with the SEC, particularly the risk factors described in our registration statement on Form S-1 for additional information. Any forward-looking statements provided during this call, including projections for future performance, are based on management's expectations as of today. Kestra undertakes no obligations to update these statements except as required by applicable law. With that, I'll turn the call over to Brian.

speaker
Brian Webster
President and Chief Executive Officer

Thanks, Neil. Good afternoon, everyone, and welcome to Kestra's first earnings call as a public company. I'd like to take a moment to thank the entire Kestra team, our board of directors, and the investors that have supported Kestra throughout our journey, including and up through last month's initial public offering. With their support, we are well positioned to take the next steps forward towards our goal of making the Assure system the standard of care for patients at risk of sudden cardiac arrest. We're excited to share with you the details of our strong performance in the third quarter fiscal year 25. But first, I would like to provide a brief overview of Kestra for those who may be new to our story. Kestra is a commercial stage wearable medical device and digital healthcare company. focused on transforming patient outcomes in cardiovascular disease using monitoring and therapeutic intervention technologies that are intuitive, intelligent, and connected. We have developed in our commercializing our cardiac recovery system platform a comprehensive and advanced system that integrates monitoring, therapeutic treatment, digital health, and patient support services into a single, unified solution. The cornerstone of our platform is the Assure Next Generation Wearable Cardioverter Defibrillator, or WCD, which is used to protect patients at an elevated risk of sudden cardiac arrest, known as SCA. Sudden cardiac arrest, or SCA, is a life-threatening emergency characterized by the abrupt cessation of the heartbeat caused by an electrical malfunction in the heart. This is typically triggered by a ventricular arrhythmia and leads to a loss of consciousness and potentially death within minutes if not promptly treated. In fact, the American Heart Association estimates that SCA causes 436,000 deaths per year, making it the third leading cause of death in the United States. Defibrillation or the delivery of an electrical shock to the heart is the only way to restore a fibrillating heart to a normal rhythm. Time is of the essence as each minute of delay in restoring the heart to a normal rhythm reduces a patient's chance of survival by seven to 10%. The average time for EMS arrival is about seven minutes from the time of a 911 call in the US. The most common location of an SCA in adults is at home or their residence. That represents about 73% of all sudden cardiac arrests, with approximately 50% of SCAs going unwitnessed. For over 20 years, WCDs have been used to protect patients at elevated risk of SCA. However, until the Assure WCD began its full US commercial launch in August of 2022, Physicians and their patients were limited to a single incumbent's device. Despite the overwhelming evidence that an external depredation shock is effective at terminating dangerous ventricular cardiac rhythms, WCD therapy remains underutilized, reaching just 14% of the eligible U.S. patient population. We believe that the low penetration of the WCD therapy is due to the limitations of the incumbent commercially available device. Commonly cited reasons for patients or providers failing to use the incumbent's device include high false alarm rate frequency, poor wearability, patient discomfort, a unisex-only garment, low utility data, and limited connectivity with patients. The Assure WCD was purpose-built to enhance patient comfort and compliance and directly address the key barriers to adoption associated with the incumbent's device. The Assure WCD drives greater patient compliance as a result of a major reduction in false alarms and enhanced comfort and wearability. In addition to the Assure WCD, our cardiac recovery system platform includes digital solutions, such as the Assure Patient Application, the Kestra Care Station Remote Patient Data Platform, Heart Alert Services, and Assure Assist Services. The Assure Patient Application engages patients with real-time mobile updates to promote compliance, while the Kestra Care Station Remote Patient Data Platform equips healthcare providers with actionable insights to support timely and informed care decisions for their patients. Heart Alert Services and the Assure Assist Services work together to enhance safety and are designed to provide critical alerts to healthcare providers for significant arrhythmias and notify emergency services when therapy is administered. In the US, we estimate that there are approximately 850,000 cardiac patients each year that are eligible for WCD prescription, representing an annual addressable market opportunity of approximately $10 billion. In 2023, approximately 120,000 patients in the US utilized a WCD, generating sales of over $1 billion. Unfortunately, the other 730,000 eligible patients went unprotected. Our mission is to protect and support this large and growing population of at-risk patients by driving increased adoption of the Assure WCD. We continue to make significant investments in infrastructure to support rapid growth and scalability specifically in our commercial organization, our supply chain, our distribution capabilities, as well as our revenue cycle management processes. We utilize a leased business model. When a patient's wear time has concluded, the Assure device is returned for reprocessing and reintroduction into Kespra's distribution system. Our substantial investment in our fleet of devices Each with a capacity for approximately three patient wares per year enables the business to scale with an attractive unit economic profile. Now, turning to our recent performance in the third quarter, Kester generated $15.1 million of revenue, which represented growth of 82% as compared to the prior year period. We note that this result was in line with the preliminary estimated financial results that were previously disclosed in our IPO prospectus. In the third quarter, we continued to reach more patients at risk of SCA, generating over 3,400 prescriptions written for the Assure system. These prescriptions help protect families from the devastating impact of cardiac arrest. As of January 31st of 2025, which is the close of our fiscal third quarter, the Assured WCD is being actively prescribed by more than 550 hospitals, representing approximately 20% of WCD prescribing hospitals in the US. Clearly, we are still in the very early innings of activating new accounts and growing our market share. To give you a sense of our potential in our top 50 hospitals, we estimate our market share to be approximately 45%. We are expanding our sales force in targeted geographies where a high volume of WCD prescriptions are being written, and we now have strong in-network payer coverage. As of January 31st, we had approximately 70 sales territories with plans for continued commercial team headcount growth over the next 12 months. Our direct sales team is supported by a contracted team of over 250 Assure patient specialists who assist patients with fitting and training of their WCD. In March, Mr. Al Ford joined Kestra as our new chief commercial officer. Al most recently served as chief commercial officer at Exomics, where he led the development and execution of their commercialization strategy. Prior to that, he was the chief commercial officer at Cardiac Science Corporation, a leader in automated external defibrillation products. With significant experience managing strategic sales and commercial operations, Mr. Ford brings valuable knowledge, perspective, and leadership to our organization. We're confident that he will be an impactful addition as we continue to drive adoption of the Assure system. We're also continuing to build the body of clinical evidence supporting the safety, efficacy, and benefits of the Assured WCD. All patients prescribed the Assured WCD in the United States since August of 2022 have been included in our post-approval study and patient registry. As of January 31st of 2025, our registry has enrolled over 17,000 patients. The real-world findings are providing further validation of the results in our pivotal trials. Our most recent FDA submission from the study reported first shock conversion efficacy of approximately 96%, a median daily use of 23.2 hours, and a low false alarm rate of only 6%, compared to 46% for the competitor's device. In late March, data from our patient registry was presented at the annual scientific sessions of the American College of Cardiology, ACC, highlighting critical insights from over 4,700 patients with newly diagnosed dilated cardiomyopathy heart failure. We used who were prescribed the WCD system. The data revealed a substantial risk of SCA within a median of just 38 days, underscoring the need for early protection and also patient compliance. These results underscore the AssureWCD's competitive advantages in wearability, usability, and patient compliance, providing strong support for continuing adoption. On the market access front, we continue to secure in-network contracts with additional health plans, with the recent addition of Kaiser Permanente, covered lives for the Assure system now total more than 285 million health plan members in the U.S. In summary, I am proud of the hard work the Kestra team has done to protect thousands of at-risk patients from cardiac arrest and even more excited about the opportunity ahead. The foundation we have built has positioned Kestra for a strong growth for years to come. We are addressing a market that is large, growing, and highly under-penetrated. Our Assure system is a truly differentiated technology that clinicians are enthusiastically prescribing to their patients who are at risk of SCA. We are making targeted investments in our commercial infrastructure and rev cycle management capabilities to capitalize on the attractive market opportunity in front of us. Following our initial public offering, we are well capitalized and focused on executing on our commitments to patients and their prescribers. Before I wrap up, I would like to just give one more shout out to the incredible Kestra team. In our recent all team member survey, our team scored 92% on the very important engagement question. I have to say I'm humbled by the commitment and passion this team has for the Kestra mission. I will now turn it over to my partner, Vasim, who will discuss third quarter financial results in more detail and provide our fiscal year 2025 revenue outlook. Vasim?

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