GeneDx Holdings Corp.

Good day, and thank you for standing by. Welcome to the GeneDx second quarter 2025 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there'll be a question and answer session. To ask a question during the session, you'll need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to turn the conference over to Sabrina Dunbar, Investor Relations. Please go ahead.

Thank you, Operator, and thank you to everyone for joining us today. On the call, we have Catherine Stoolin, President and Chief Executive Officer, and Kevin Feely, Chief Financial Officer. Earlier today, GNDX released financial results for the second quarter ended June 30, 2025. Before we begin, please take note of our cautionary statements. We may make forward-looking statements on today's call, including about our business plans, updated 2025 guidance, and outlook. Forward-looking statements inherently involve risks and uncertainties and only reflect our view as of today, July 29th, and we are under no obligation to update. When discussing our results, we refer to non-GAAP measures, which exclude certain items from reported results. Please refer to our second quarter 2025 earnings release and slides available at ir.gndx.com for definitions and reconciliations of non-GAAP measures. and additional information regarding our results, including a discussion of factors that could cause actual results to materially differ from forward-looking statements. And with that, I'll turn the call over to Catherine.

Thanks, Sabrina, and good morning, everyone. Today, I'm incredibly proud to share that our team's work not only met but exceeded expectations, achieving a major milestone of delivering over $100 million in revenue in a single quarter for the first time. Our strong second quarter performance was driven by our core business, underscoring its strength and resilience. These results, coupled with the ever-expanding opportunities ahead, demonstrate that we're just beginning to deliver on the promise of how our genomic technology can fundamentally transform healthcare. Our vision is for a world where genetic information is delivered as early as possible to prevent unnecessary suffering and lead to healthier lives for all. Today, we're waiting for symptoms to develop and for disease to progress, not only over the course of months, but over the course of years. We've never been more resolute about our commitment to radically change this. Shifting from sick care to healthcare, driving better health outcomes, better economic value, and a better healthcare system for us all. At a recent all company meeting, a patient advocate reminded us why we do this. His diagnostic odyssey, lasted nearly two decades before he received answers. His story highlights a systemic issue. Care often starts too late, with children waiting an average of five years for a genetic diagnosis. This is totally unacceptable given the solutions we have in hand today at GeneDx. Thanks to our investment in innovation and scale, genomic testing, once considered slow and costly, now delivers answers not in weeks, or even days, but sometimes hours, and it costs lower than ever before. Our technology is shifting healthcare from reactive to proactive, benefiting both patients and the healthcare system. GeneDx is uniquely positioned to bring genomic information into mainstream medicine. We diagnose more rare diseases than anyone in the world and are the number one genetic testing brand amongst pediatric healthcare providers with 80% market share amongst geneticists. Our unmatched expertise and proprietary data set enriched for rare disease, inclusive of asymptomatic individuals supported by clinical data and representative of the US population, has enabled us to identify over 500 gene disease relationships to date, ensuring more patients receive answers with greater accuracy. This is what sets GeneDx apart. and why we're the clear leader in ushering in the next era of genomics-informed healthcare. Our competitive advantage grows with every patient we test. With over 850,000 exomes and genomes and over 7 million phenotypic data points, we've built one of the world's most comprehensive genomic data sets, and we are putting it to work for patients. Our proprietary interpretation platform grows stronger with each new patient we test, building upon our data advantage and leveraging AI to drive greater accuracy, speed, and scalability. Our lead will only continue to expand as we integrate Fabric Genomics and its proprietary algorithms into the core platform, further strengthening our competitive edge and positioning us for unprecedented scale. As we grow the business and reach new clinicians, we will continue to stand out on quality, accuracy, scale, and experience. Put another way, there's no one who can check all the boxes of being better, faster, and cheaper than GeneDx. We have everything we need to remain the leader, even as competition emerges. We've established a strong foothold with geneticists who choose us eight times out of 10, demonstrating the trust we've built in our core market. These geneticists are key influencers, and their continued support is helping us win over other specialists as we grow. And that's what's happening today, as our reach has broadened and deepened. In the second quarter, pediatric neurologists made up a majority of new exome and genome ordering providers, and we've now captured nearly a third of our target clinicians in this segment. Most of our Q2 volume growth came from patients within our core indications, but we're also seeing early signs of increased adoption as we introduce new indications like cerebral palsy. This expansion has helped us reach 14% of our target patients, which is growth from last quarter as it represents the same share as a larger patient pool. In Q2, we also began engaging pediatric immunologists, an entirely new audience, focusing on children with inborn errors of immunity. Based on our experience with pediatric neurologists, we expect to see momentum build in these new indications and call points as our relationships deepen. Another growth driver for the second half is the NICU, which represents a billion-dollar opportunity. Fewer than 5% of babies in the NICU currently receive a genetic test, so this is an important market for us to develop. Each year, 235,000 infants are treated at approximately 800 Level 3 or Level 4 NICUs that could benefit from rapid genomic testing, 20% of which are already GDX clients. Importantly, 42 out of 50 top NICUs have already ordered testing from us this year, and we're continuing to take a top-down and bottom-up approach to scale volume. We recognize the need for three things to succeed in the NICU. data, product, and scale, and we now have all three. Our enterprise sales team is equipped with seek-first data demonstrating up to 60% of infants in high-acuity NICUs would benefit from rapid genome sequencing and a CFO calculator that demonstrates the financial benefits of testing to each hospital. Our ultra-rapid test delivers results in as early as 48 hours and Epic Aura integrations are supporting a seamless delivery of our testing to patients. We have three health systems live on Epic Aura, and we expect to have a dozen hospitals on board and a few thousand tests performed by year end. As protocols evolve and whole system engagement increases, we're well positioned to scale NICU testing significantly. While the NICU represents a significant and growing frontier for us, An even larger transformative opportunity is the general pediatric market. This shift is largely driven by recent guidance from the American Academy of Pediatrics recommending pediatricians use exome and genome sequencing as a first-tier test for children with global developmental delay or intellectual disability. This is a sea change in pediatric healthcare. Previously, pediatricians referred these children to specialists be getting a long, painful odyssey for families. Now, with new guidance, that can all change. The general pediatrician market remains untapped. Of the 60,000 general pediatricians in the U.S., about 25,000 diagnosed children with developmental or intellectual delays, representing 600,000 children who could benefit from our testing. To accelerate adoption of the new guidelines, we will have a presence at the annual AAP meeting in September, where we'll engage directly with clinicians. We're also investing in continuing medical education to ensure pediatricians understand the new guidance and how to integrate exome and genome testing into their practice. By collaborating with local AAP chapters and leveraging our marketing engine, we're building awareness and trust in GeneDx, making it easier for pediatricians to navigate this shift and confidently order our tests. Concurrently, we're improving our customer experience to make it more accessible to a non-specialist. We're taking a targeted commercial approach in Q3, starting with the fewer than 5% of pediatricians already ordering genetic tests for a high number of CDID patients, allowing us to learn and refine our strategy before scaling up. With a $2.5 billion market opportunity ahead, we expect the broader adoption to take 18 to 24 months. while pediatricians represent a significant long-term opportunity. For the remainder of the year, we expect growth to be driven by our core customer base of specialists diagnosing patients with epilepsy, autism, and DDAD, supplemented by new medications and the NICU. Our work to date has shown the value of testing symptomatic patients, but we know the next step forward is to provide a diagnosis before symptoms begin with genomic newborn screening. The Guardian study has shown that whole genome sequencing can identify serious, treatable genetic conditions in over 3 percent of newborns, 92 percent of which would have been missed by standard screening. Legislative progress, such as Florida's Sunshine Genetics Act, is paving the way for broader adoption. With experience screening over 17,000 newborns, our robust underlying data and our ability to deliver at scale, we are uniquely positioned to play a key role as this initiative evolves. All the while, our team is forging partnerships with pharmaceutical companies of every size, because while only 5% of rare diseases have an approved therapy, we know that our unparalleled genomic data can help accelerate the development of new treatments. We are positioned as the partner of choice, ready to support biopharma in harnessing genetic insights to inform and transform therapeutic pipelines. Our commitment is simple, get families the answer they need sooner, helping patients get on the right path to better health while reducing unnecessary costs across the healthcare system. Not only are we leaders in genomic testing, but we're extending that lead and continually raising the bar by investing in our strategy, our technology, and our people. While our mission is bigger than profitability, we're proud that we've built a business that is both purposeful, and profitable. That success is thanks to our dedicated team, our partners, and a shared belief in what's possible when innovation meets conviction. With that, I'll hand things over to Kevin.