GeneDx Holdings Corp.

Good day, and thank you for standing by. Welcome to the GeneDx third 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 answer 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 Stulen, President and Chief Executive Officer, Brian DeTero, Chief Operations Officer, and Kevin Feeley, Chief Financial Officer. Earlier today, GDX released financial results for the third quarter and is September 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, October 28th, and we are under no obligation to update. When discussing our results, we refer to non-GAAP measures, which include certain items from reported results. Please refer to our third 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 Katherine. Thank you, Sabrina, and good morning, everyone.

The third quarter was another exceptional quarter for GeneDx. We continued to drive record growth while maintaining our commitment to profitability. For us, better patient care and profitability go hand in hand because our ambition is truly transformative. to fundamentally alter how precision healthcare is delivered, making it more accessible, effective, and patient-centric. We envision a world where any genetic disorder is diagnosed quickly to prevent disease progression and ensure everyone has a chance to live a long and healthy life. Achieving that vision requires a fast-growing, disciplined, profitable business that delivers both life-changing answers for patients and long-term value for shareholders. Based on our momentum exiting this quarter, we're raising our 2025 revenue guidance to $425 to $428 million. Our North Star, the goal that drives each and every one of us at ADX, is to diagnose disease earlier for as many families as possible. Our strategy to do so is to, one, drive high profitable growth, two, offer the best in class diagnostics products and experience for clinicians and patients globally, And three, build the network effects required to usher in the next era of precision medicine. Across all three focus areas, we are leveraging the power of GeneDx and Simity, the largest rare disease data set, to generate deep genomic insights that enable fast and reliable diagnoses and fuel the precision medicine revolution. Just last week, the FDA granted breakthrough device designation to our ExomeDx and GenomeDx tests. offering powerful validation that our industry-leading technology is the gold standard in transforming lives and shaping the future of health. There are over 10,000 rare diseases impacting one in 10 Americans, most of them children, and it still takes an average of five years to reach an accurate diagnosis. Receiving an accurate genetic diagnosis is a pivotal milestone in a patient's journey, but it's often not the end. Today, 95% of rare diseases have no approved treatment, that is the largest provider of rare disease diagnoses in the world. GeneDx will be central in changing that. As we look to our future, GeneDx isn't just a starting point for rare disease. We're the nexus, connecting patients, biopharma, health systems, payers, policymakers, and advocacy to unlock the full potential of genomic medicine. We recently announced two key executive hires, Lisa Gurry as Chief Business Officer and Dr. Mimi Lee as Chief Precision Medicine Officer. to unite our data, diagnostics, and partnerships so that clinical adoption, equitable access, and therapeutic advancements reinforce one another, creating a network effect. We are uniquely positioned to move our system from sick care to healthcare, and strengthened by the network effects, we will deliver on the promise of precision medicine for all. What fuels our business is growth and diagnostic testing at scale, and our strategy is twofold. We're deepening our penetration while widening the market enabling us to serve more patients today while opening access for patients tomorrow. Our existing markets of geneticists and pediatric neurologists continue to deliver impressive growth, and we have ample room to run. And with updated guidance from the American Academy of Pediatrics now in place, we can now shorten that multi-year diagnostic odyssey by meeting parents where they go first, their pediatrician. Our commercial build-out is underway, and we expect to nearly double our sales force over the coming quarters. for the dedicated Gen-T teams. We're also leading medical education on the updated guidance, expanding GeneDx's authority as the leader in genomics to this new cohort of clinicians, many of whom are learning about these changes for the first time from us. We're also investing in customer experience to drive utilization. The opportunity is significant, and we expect it will take 18 to 24 months from the June update before we see real adoption. Turning to the inpatient setting, the NICU remains underpenetrated and continues to be a focus, with less than 5% of NICU patients receiving any genetic testing today. We have eight Epic Aura integrations live and are on track to deliver at least 12 by the end of the year. Our ultra-rapid genome continues to prove its value for critically ill infants, and as protocols evolve and whole system engagement increases, we're well-positioned to significantly scale testing in Level 3 and Level 4 NICUs over time. Our work to date has shown the value of testing symptomatic patients, but we know the next step forward is to enable proactive personalized care beginning at the earliest moment possible. Our leadership in genomic newborn screening, from supporting pioneering research to enabling clinical adoption in Florida, reflects our mission to drive true longevity and highlights our unique ability to expand access to this technology at scale. Our work on the Guardian study generated foundational clinical data to support adoption, demonstrating an over 3% true positive rate for actionable conditions at birth. This quarter, we announced our role in two new pivotal initiatives, the NIH's Beacon Program and the Sunshine Genetics Network. These programs are relying on D&D Access as a trusted advisor in newborn screening because we have the unique talent and experience to design programs that are clinically impactful, equitable, and scalable. Broad adoption of newborn screening will force the system from reactive to proactive, advancing our mission and accelerating impact at population scale. At the same time, exome and genome testing can have significant utility later in life. Adult conditions represent another large, untapped market where GDX is uniquely positioned to offer diagnoses for cardiovascular conditions, neurodegenerative diseases, and many others. And as we grow our footprints domestically, we're also poised to address growing opportunities internationally. The Fabric Genomics platform offers us flexibility to serve global markets at scale, and we're excited to have seeds on the ground in key ex-US regions to develop these markets. We're proud to have built a business that delivers both purpose and profit to fuel reinvestment. And the strength of our model today is laying the foundation for an exciting future. With that, I'll pass it over to Kevin to share more about our results.