GeneDx Holdings Corp.

Good day and thank you for standing by. Welcome to the GNDX fourth quarter 2024 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 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised, today's conference is being recorded. I would now like to hand the conference over to your speaker today, Sabrina Dunbar, Investor Relations. Please go ahead.

Thank you, operator, and thank you, everyone, for joining us today. On the call, we have Catherine Stuland, President and Chief Executive Officer, and Kevin Feely, Chief Financial Officer. Earlier today, GNDX released financial results for the fourth quarter and December 31st, 2024, and full year 2024. Before we begin, please take note of our cautionary statement. We may make forward-looking statements on today's call, including about our business plans, guidance, and outlook. Forward-looking statements inherently involve risks and uncertainties and only reflect our view as of today, February 18th, 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 fourth quarter 2024 and full year 2024 earnings release and slides available at ir.gnds.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. Good morning, everyone, and thank you for joining us today. 2024 was a remarkable year for GDX across all metrics. We cemented and extended our position as the market leader in exome and genome testing, expanded patient access, solidified our operating processes across all aspects of the business, and started to generate cash to fuel the next leg of growth. Our fourth quarter results surpassed expectations with revenues exceeding $95 million and gross margins expanding to 70%. While providing early and precise genetic diagnoses remains our purpose, creating a financially strong business drives our progress. We are dedicated to helping as many patients as possible, and it's not just about what we do, but how we do it in service of our customers. with clinical excellence, urgency, and integrity. Our flagship exome and genome business delivered enormous growth in 2024, and we're bringing our focused operational discipline and commitment to profitable growth with us into 2025. In the coming year, we'll be layering on additional investments into growth, scale, innovation, and talent to add velocity to our market development. Fueled by our 2024 and early 2025 momentum, We're setting guidance for 2025 to a range of $350 million to $360 million in revenue, with at least 30% growth in exome and genome volume and revenues. What's unique about our technology is that it enables a more efficient model, both for families and for the U.S. healthcare system. Broad genetic testing, like our differentiated exome and genome services, are massively underutilized. causing the over-utilization of other diagnostic tests that don't accurately diagnose disease. The economic burden of rare diseases is estimated to be around a trillion dollars annually, with delayed diagnoses contributing heavily to this cost. On average, a child with a rare disease will undergo around 16 ineffective tests and three misdiagnoses. The most recent literature tells us that on average, a child with a rare disease will go on a five-year diagnostic odyssey. That's down from six years previously, which implies that we're succeeding in our mission. By enabling earlier diagnosis with our products, GeneDx alleviates unnecessary suffering for patients and families and offers a readily available solution to reduce inefficient healthcare spending. There's a reason healthcare spend is top of mind for this administration, policy makers, insurers, and hospital systems. And GeneDx is in a unique position to help them solve this costly problem. GeneDx is proud to be helping American families have healthier kids and healthier lives, and by doing so, reducing healthcare costs. With a large market opportunity at hand, it's important to understand that not all exome and genome tests are created equal. There's a reason 8 out of 10 clinicians who order exome testing choose GeneDx. fueled by more than 750,000 exomes and genomes, our rapidly growing data asset and clinical expertise differentiate our products from competitors by enabling us to identify novel gene disease connections that are not widely available and ensuring we can offer the clinical utility, accuracy, and easy-to-understand reports that clinicians need. As we set our sights on offering these services to pediatricians, neurologists, cardiologists, and more specialists in the future. We've recruited some of the best product talent to deliver the smoothest end-to-end customer experience. Throughout 2025, we'll be releasing a steady stream of new features designed to further simplify our customer experience to make it the easiest to use for all. We already made great progress in the first few months of the year, and our Epic Aura integration is just one example of this. We've launched GDX ordering and resulting workflows at patients' bedsides and in clinician exam rooms. While we have the first mover advantage, there's a large unmet need ahead, and we're running as fast as we can to help as many families as quickly as possible. Our position becomes more formidable, and our competitive advantage strengthens with the compounding force of each additional patient that we sequence, creating a flywheel effect that makes our underlying interpretation platform smarter, faster, and more scalable. We're seizing our advantage to accelerate market development by scaling utilization of rapid genome testing in the NICU and expanding our dominance in the outpatient setting. Last week, we announced our ultra-rapid whole genome sequencing product, which delivers results in as soon as 48 hours. Our ability to offer an ultra-rapid genome demonstrates how our lab operations continue to innovate. Throughout 2025 and beyond, we're prepared to capitalize on coupling our clinically-enriched data set with AI, machine learning, and automation to drive cost and turnaround times down in service of patients, providers, and partners. In preparation for our full launch into the NICU in 2025, we recently expanded our enterprise sales team, launched multiple genome product enhancements and Epic Aura, and are bringing our ultra-rapid product to market. In the outpatient setting, pediatric neurology proved successful, driving most of the growth in 2024. We've only scratched the surface of the outpatient segment's potential with a focus on patients with epilepsy, autism, and intellectual and developmental delay. There are countless applications still to come in 2025. We'll be leaning into new patient populations. Cerebral palsy and hearing loss are just two such examples we'll target as we expand our footprint. Additionally, we're developing new patient access channels like our new telehealth pathway, which accelerates access to testing for parents and caregivers via a streamlined referral process. Ultimately, the first line of defense for families lies within their general pediatrician. When the American Academy of Pediatrics guidelines are updated and reimbursement pathways are clear, we are ready to deploy a commercial strategy and meaningfully expanded sales force against this new call point. Longer term, we will extend our market leadership to the genomic newborn screening market. In total, pediatric testing is a $25 billion market, and while we've made progress, this opportunity remains largely untapped with multiple levers for growth ahead. While rare diseases affect 1 in 10 Americans, they also affect over 300 million people worldwide. We will strategically target opportunities outside the U.S. to meet the incredible need for testing on a broader scale. All of this is underpinned by our ability to provide valuable products and services to biopharma, leveraging our unique data assets to enable faster, cheaper, and more effective therapeutic development, all in service of expediting therapies to market for patients. We're in a privileged position to be the market leader with the product, quality, scale, talent, and commercial strategy to transform the standard of care and win in an ever-expanding market. The opportunity ahead is ours for the taking, and we're moving quickly and decisively to claim it. With that, I'll turn it over to Kevin.